Today's News and Commentary

About the public’s health

Dr. Fauci: Second wave isn't inevitable if we do this: In a video interview he says we need to follow the science (masks, social distancing, etc.) and not open up public activities too early. Oh, yes…and hydroxychloroquine does not work against SARS-CoV-2

WHO creates foundation to boost funding in coronavirus fight: “The World Health Organization announced on Wednesday the creation of a foundation to tap new sources of funding that could help ease a potential cash shortage as it leads the global fight against the coronavirus pandemic.”

Comparison of Clinical Characteristics of Patients with Asymptomatic vs Symptomatic Coronavirus Disease 2019 in Wuhan, China: “Our finding…suggests that damage to the immune system in asymptomatic infections was milder compared with symptomatic infections. Although patients who were asymptomatic experienced less harm to themselves, they may have been unaware of their disease and therefore not isolated themselves or sought treatment, or they may have been overlooked by health care workers and thus unknowingly transmitted the virus to others. Fortunately, patients with asymptomatic SARS-CoV-2 infection have a shorter duration of viral shedding from nasopharyngeal swabs and lower risk of a recurring positive test result of SARS-CoV-2 from nasopharyngeal swabs, which can provide a reference for improving the prevention and control strategies for patients who are asymptomatic.”

Effects of a Workplace Wellness Program on Employee Health, Health Beliefs, and Medical Use: A Randomized Clinical Trial: Evaluations of workplace wellness programs have revealed widely different results- depending on such factors as the target of the intervention (like smoking cessation or weight loss), the company culture, and method of intervention (such as bonuses, penalties, or other benefits). So each study needs to be interpreted very cautiously when generalizations are made about their effectiveness. In this study: “…a comprehensive workplace wellness program had no significant effects on measured physical health outcomes, rates of medical diagnoses, or the use of health care services after 24 months, but it increased the proportion of employees reporting that they have a primary care physician and improved employee beliefs about their own health.See the editorial as well: Taking Stock of Employer Wellness Program Effectiveness—Where Should Employers Invest?

Half of Americans in new poll say they would get COVID-19 vaccine: The Associated Press-NORC Center for Public Affairs Research poll found that 49 percent of respondents said they would get a vaccine for the disease, which is caused by the novel coronavirus. Twenty percent of respondents said they would not, and 31 percent said they weren’t sure yet.” Safety is the major concern of those who said they would not get the vaccine.  

GSK targets production of 1bn doses of coronavirus vaccine booster: “UK drugmaker GlaxoSmithKline plans to produce 1bn doses of a vaccine booster as it steps up its preparations for an eventual immunisation for coronavirus.” Such boosters, called adjuvants, enhance the immunologic response to vaccines and also may allow a lower effective dose to be used - thus extending the available supply.

EMA Picks University to Lead Real-World Monitoring of COVID-19 Vaccines “European Medicines Agency (EMA) has signed a contract with Utrecht University to lead a research project for real-world monitoring of COVID-19 vaccines once they are authorized in the European Union.”

Thinking twice about the rush to give CPR to COVID-19 patients: From the AMA, here is a discussion of and references on ethical decisions regarding exposure of healthcare workers to contagion while performing CPR.

About pharma

Remdesivir for 5 or 10 Days in Patients with Severe Covid-19:”In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined.” With cost becoming more of a consideration, this finding is good news if results are further confirmed.

FDA finds likely carcinogen in the common diabetes drug metformin. Will recalls follow?:”The FDA found carcinogen contamination in extended-release formulations of metformin, supporting outside laboratory Valisure's findings in early March, a spokesman said Thursday. 
Tested lots of extended-release metformin showed levels of N-Nitrosodimethylamine (NDMA)—a likely human carcinogen that's led to recalls of ‘sartan’ blood pressure drugs and the heartburn remedy Zantac—above acceptable limits, the FDA said. Those elevated levels weren't found in samples of metformin's immediate-release formula.”

Financial ties between leaders of influential US professional medical associations and industry: cross sectional study: “Financial relationships between the leaders of influential US professional medical associations and industry are extensive, although with variation among the associations. The quantum of payments raises questions about independence and integrity, adding weight to calls for policy reform.” You should look at the methodology (is research money that is disclosed a problem?) and differences across organizations (ties involving the American College of Physicians and American Psychiatric Association are markedly lower than for other groups). Also, the article splits the analysis between the ties with pharma and devices.

Merck adopts ‘error catastrophe’ coronavirus drug: “Merck is launching its hunt for a coronavirus treatment with a pill developed by US academics that is designed to force an “error catastrophe” on viruses. The compound, which is known as EIDD-2801, works by planting molecules in a virus’s RNA genetic material that then trigger a cascade of mutations, which ultimately kill it. The drug completed its first safety trial in about 100 human volunteers in the UK and is set to begin extensive clinical testing in the US and UK early in June.”

FDA Approves Only Drug in U.S. to Treat Severe Malaria: “…the U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients. Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen…According to the CDC, approximately 2,000 cases of malaria are diagnosed in the United States each year, with 300 of those infected having severe disease.”

6 BCBS companies sue CVS, claiming decadelong insurance fraud scheme: “Six Blue Cross Blue Shield companies filed a lawsuit against CVS Health, claiming the retail pharmacy chain has ‘intentionally engaged’ in a fraud scheme for more than a decade to overcharge for prescription drugs by submitting insurance claims for payment at artificially inflated prices.”

Evidence-Based Quality Scores for Rating Drug Products and Their Utility in Health Systems: This pre-reviewed paper proposes: “A system of quality scores… to enable health-systems and other purchasers and payers of medication to differentiate among drug products according to evidence-based metrics. Metrics influencing the quality scores described herein include both broadly applicable regulatory information and more drug-specific, third-party chemical analysis information.” The quality measure evaluates manufacturing not the actual drug effectiveness.

About healthcare IT

Barriers to Hospital Electronic Public Health Reporting and Implications for the COVID-19 Pandemic: This survey is another reminder about interoperability problems: “Public health agencies’ inability to receive electronic data is the most prominent hospital-reported barrier to effective syndromic surveillance. This reflects the policy commitment of investing in information technology for hospitals without a concomitant investment in IT infrastructure for state and local public health agencies.”

Is the glass half full or half empty? Here are two articles about the same survey whose headlines reach opposite conclusions:
Surveys Suggest Seniors Aren’t Using Telehealth During COVID-19 Crisis: ”In a survey of roughly 1,000 seniors on Medicare Advantage plans conducted earlier this month by the Better Medicare Alliance, just 24 percent said they’ve used telehealth during the COVID-19 crisis. And just 52 percent of the seniors said they’d be comfortable using telehealth to access care, while 30 percent said they’d be uncomfortable and 18 percent were unsure.”

Medicare Advantage members are taking to telehealth: “A new poll found that roughly half of seniors are comfortable using telehealth to get healthcare, and those that do largely say they had a favorable experience.
The poll, conducted by Morning Consult and sponsored by the Better Medicare Alliance, comes as providers and insurers have started to embrace telehealth amid the COVID-19 pandemic.
The survey of more than 1,000 seniors found 52% are comfortable using telehealth for their healthcare, with 30% uncomfortable and another 18% unsure.”

About health insurance

Hospitals not entitled to additional payments after 'two-midnight' rate cut: “A federal appeals court said a group of hospitals that received lower Medicare reimbursement because of a rate reduction implemented by HHS aren't entitled to additional payments, according to court documents.
For fiscal year 2014, HHS implemented a 0.2 percent rate reduction in an effort to reduce costs associated with its ‘two-midnight’ rule. The rule says costs for hospital stays of a least two midnights are presumptively appropriate for reimbursement at inpatient rates. After revisiting the actuarial processes behind the cuts, HHS eliminated the 0.2 percent rate reduction for fiscal year 2017 and implemented a one-time 0.6 percent reimbursement rate increase to account for the three years of cuts.”

Public Option Could Lower Health Insurance Premiums, But Would Not Substantially Raise Number of Insured: This RAND Corporation study, published today, modeled “four scenarios for adding a public option for individual coverage available nationwide” The “researchers found that premiums for public plans could be 10% to 27% lower than private insurance plans because of lower provider payment rates in the public option.”
However, a “public option had much less impact on boosting the number of people with insurance. Under three of the scenarios, the number of uninsured people fell 3% to 8%, while the number of uninsured declined marginally under a fourth scenario studied.”

About healthcare companies

20 healthcare companies with biggest annual profits: The list is from the latest “Fortune 500.”

Today's News and Commentary

About the public’s health

Here’s what we have to do to show a coronavirus vaccine works: A good review of what it takes to develop a successful vaccine against SARS-CoV-2.

New Ranking of Nations Top Employers’ Response to Pandemic: From Forbes, here are highlights of the top 25 companies. The top 5 are: Verizon, Target, At&T, Walmart, an T-Mobile.

They Evoke Darth Vader, but These Masks May Save Your Doctor’s Life: A good pictorial view of what different masks look like and how well they work.

Where U.S. coronavirus cases are on the rise: “Alabama had the biggest weekly increase at 28%, Missouri’s new cases rose 27% and North Carolina’s rose 26%, according to the analysis of data from The COVID Tracking Project, a volunteer-run effort to track the outbreak. 
New cases in Georgia, one of the first states to reopen, rose 21% after two weeks of declines. The state attributed the increase to a backlog of test results and more testing.”

‘The house was on fire.’ Top Chinese virologist on how China and U.S. have met the pandemic: The article is a good summary of what China did to combat the COVID-19 pandemic and what the situation is now.

About pharma

Taxpayers paid to develop remdesivir but will have no say when Gilead sets the price: A reminder that the government funds basic research for many important medications, but does not demand payback from the companies that manufacture and sell the products.

Big Pharmacy Chains Also Fed the Opioid Epidemic, Court Filing Says:”New details emerge in a lawsuit asserting that chains including CVS, Rite Aid and Walgreens sold millions of pills in small towns but rarely flagged suspicious orders to authorities.”

FDA updates COVID-19 compounding guidance with reporting clarification:”The FDA updated two separate guidance documents regarding compounding of fifteen drugs that are currently in shortage; most of them are medicines that treat patients who require intubation and mechanical ventilation. The first applies to outsourcing facilities, while the second applies to smaller pharmacy compounders.”

FDA approves 2 drugs to combat COVID-19 shortages: “The FDA approved an application from Amneal Pharmaceuticals to make dexmedetomidine hydrochloride 0.9 percent sodium chloride injection, which is used to sedate ventilated patients and non-intubated patients during surgery. 
The agency also approved an application from Accord Healthcare to make succinylcholine chloride injection, which is used for general anesthesia and to provide muscle relaxation during surgery or ventilation.”

Exclusive: big pharma rejected EU plan to fast-track vaccines in 2017:”The world’s largest pharmaceutical companies rejected an EU proposal three years ago to work on fast-tracking vaccines for pathogens like coronavirus to allow them to be developed before an outbreak, the Guardian can reveal.
The plan to speed up the development and approval of vaccines was put forward by European Commission  representatives sitting on the Innovative Medicines Initiative (IMI) – a public-private partnership whose function is to back cutting-edge research in Europe – but it was rejected by industry partners on the body.”

About healthcare professionals

Practice closures and staff layoffs resulting from pandemic: “Around 58,000 primary care practices may close by the end of June, according to the American Academy of Family Physicians, while many others have laid off and furloughed stuff.
Via its HealthLandscape interactive web-based tool, AAFP projects that physician practice wages and salaries will plummet by more than $64 billion by the end of June and practice job losses—including physicians—will be slashed by 784,133.
By the end of May, AAFP projects that 38,693 practices will close, 522,756 job losses will occur, and wages and salaries will be reduced by more than $43 billion.
In more bad news, only 47 percent of primary care practices said they had enough cash on hand to stay open for four more weeks, according to an April Primary Care Collaborative survey, and 42 percent are furloughing or laying off staff.”

About hospitals

Ascension reports $2.7B net loss in Q3: A reminder about how much the COVID-19 pandemic has hit hospitals’ finances.

About health insurance

CMS: 88 Part D, Medicare Advantage insurers sign up for insulin copay model: “The Trump administration announced 88 Medicare Advantage and Part D plan sponsors have applied to lower insulin costs for the 2021 plan year in a bid to grapple with the rising expense of the diabetes treatment.
The Centers for Medicare & Medicaid Services (CMS) said Tuesday that means more than 1,750 standalone plans have decided to participate in the Part D Senior Savings Model. Participating Part D plans will provide Medicare beneficiaries with insulin capped at a $35 copay for a monthly supply.
That $35 copay will extend from the beginning of the year and through the Part D coverage gap.”

About healthcare quality

Survival After Cancer Treatment at Top-Ranked US Cancer Hospitals vs Affiliates of Top-Ranked Cancer Hospitals: “These findings suggest that short- and long-term survival after complex cancer treatment were superior at top-ranked hospitals compared with affiliates of top-ranked hospitals.” Consider the implications for brand dilution.

About healthcare IT

List of ransomware that leaks victims' stolen files if not paid: Each of 15 companies is profiled. If so much information is available, why haven’t they been shut down?

Today's News and Commentary

About the public’s health

Cloth Masks May Prevent Transmission of COVID-19: An Evidence-Based, Risk-Based Approach: “When we apply the principles of evidence-based medicine to public policy, there is high-quality, consistent evidence that many (but not all) cloth masks reduce droplet and aerosol transmission and may be effective in reducing contamination of the environment by any virus, including SARS-CoV-2. No direct evidence indicates that public mask wearing protects either the wearer or others. Given the severity of this pandemic and the difficulty of control, we suggest that the possible benefit of a modest reduction in transmission likely outweighs the possibility of harm.” A major caveat: Effectiveness depends on the material, number of layers, how the mask is worn and how often it is used.

WHO warns that 1st wave of pandemic not over, dampens hopes: “As Brazil and India struggle with surging coronavirus cases, a top health expert is warning that the world is still in the very middle of the outbreak, dampening hopes for a speedy global economic rebound and renewed international travel.
‘Right now, we're not in the second wave. We're right in the middle of the first wave globally,’ said Dr. Mike Ryan, the World Health Organization's executive director.”

77 Nobel Laureates Denounce Trump Officials For Pulling Coronavirus Research Grant: “In an open letter to a top Trump Administration official, 77 Nobel prize-winning American scientists say they are ‘gravely concerned’ about the recent abrupt cancellation of a federal grant to a U.S. non-profit that was researching coronaviruses in China. The laureates say that the move, announced on April 24, ‘sets a dangerous precedent by interfering in the conduct of science’ and ‘deprives the nation and the world of highly regarded science that could help control one of the greatest health crises in modern history and those that may arise in the future.”

WHO says 80 million babies are missing out on routine childhood vaccines: As perviously reported, the COVID-19 pandemic has severely curbed needed routine immunizations, particularly for children. This article further quantifies how serious this problem is.

For Parents: Multisystem Inflammatory Syndrome in Children (MIS-C) associated with COVID-19: From the CDC: This publication explains the severe form of COVID-19 that can afflict children.

Safety of sugar substitutes remains inconclusive after years of research: The message is in the headline but the article offers a good summary of the data and current opinions.

‘This Is Not the Hunger Games’: National Testing Strategy Draws Concerns: “The Trump administration’s new testing strategy, released Sunday to Congress, holds individual states responsible for planning and carrying out all coronavirus testing, while planning to provide some supplies needed for the tests.
The proposal also says existing testing capacity, if properly targeted, is sufficient to contain the outbreak. But epidemiologists say that amount of testing is orders of magnitude lower than many of them believe the country needs.”

Here’s How Wuhan Tested 6.5 Million for Coronavirus in Days: And on a similar theme, why can Wuhan test so many people in such a short time and this country cannot do the same?

Findings from investigation and analysis of re-positive cases: From the Korean CDC:

○  Investigation and contact investigation have been completed for 285 (63.8%) of the total 447 re-positive cases (as of 15 May).

○ 59.6% were tested as a screening measure, and 37.5% were tested because of symptom onset. Of the 284 cases for which symptoms were investigated, 126 (44.7%) were symptomatic.

○ From the 285 re-positive cases, a total of 790 contacts were identified (351=family; 439=others). From the monitoring of contacts, as of now, no case has been found that was newly confirmed from exposure during re-positive period alone.(Emphasis added)

The dynamics of humoral immune responses following SARS-CoV-2 infection and the potential for reinfection : “It is clear that most people infected with SARS-CoV-2 display an antibody response between 10 and 14 days after infection. In some mild cases, detection of antibodies requires a long time after symptoms, and in a small number of cases, antibodies are not detected at all, at least during the time scale of the reported studies. There is a paucity of information about the longevity of the antibody response to SARS-CoV-2, but it is known that antibodies to other human coronaviruses wane over time, and there are some reports of reinfection with homologous coronaviruses after as little as 80 days. Thus, reinfection of previously mild SARS-CoV-2 cases is a realistic possibility that should be considered in models of a second wave and the post-pandemic era. Obtaining longitudinal serological data where both binding titres and functional neutralization titres are stratified by age groups and previous disease severity status should be undertaken as a matter of urgency.”

SARS-CoV-2 infection protects against rechallenge in rhesus macaques: And one more article that may provide useful information in humans: “These data show that SARS-CoV-2 infection induced protective immunity against re-exposure in nonhuman primates.”

What Role Should Employers Play in Testing Workers?: Companies have an interest in their workers’ testing results for two reasons: They want them to return to work safely and they act as the insurer for many employees. “While public health experts and government officials have emphasized that widespread testing will be critical to reopening, there is little clear guidance from state and federal agencies on the role employers should play in detecting and tracking the coronavirus. As a result, businesses are largely on their own in sorting out whether to test — and how to do it — to reassure employees and customers. For now, many companies are just waiting.”

The government has spent decades studying what a life is worth. It hasn’t made a difference in the covid-19 crisis:”The calculation — known as Value of a Statistical Life or VSL — is the amount people are willing to spend to cut risk enough to save one life. The VSL at most federal agencies, developed over several decades, is about $10 million. If a new regulation is estimated to avoid one death a year, it can cost up to $10 million and still make economic sense…
Two key federal agencies that previously have used this type of research to support policy decisions under Trump — including the Centers for Disease Control and Prevention and the White House Office of Management and Budget, which oversees federal regulations — say they are not using this type of cost-benefit analysis in their response to the pandemic.” This measure is obviously very different from a Quality Adjusted Life Year (QALY) which economists generally value at $100 thousand.

About pharma

Japan delays approval of Fujifilm drug for treating coronavirus: “Japan has delayed the approval of an anti-flu drug as a potential coronavirus treatment after interim results from its first randomised clinical trial provided no solid evidence of its effectiveness.”

WHO halts hydroxychloroquine trial for coronavirus amid safety fears:”The WHO’s director-general Tedros Adhanom Ghebreyesus said in light of a paper published last week in the Lancet that showed people taking hydroxychloroquine were at higher risk of death and heart problems than those who were not, it would pause the hydroxychloroquine arm of its solidarity global clinical trial.”

Remdesivir for the Treatment of Covid-19 — Preliminary Report: “Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.” Note the focus on hospitalized patients with evidence of lower respiratory tract infection.

About health insurance

Congress said COVID-19 tests should be free — but who’s paying?: This article raises a question I previously asked- who picks up the final bill if COVID-19 related services are”free” to the patient? The article explains a variety of practices but does not give any firm answers. Ultimately, the insurer is responsible but getting to that point is not straightforward.

CMS caps out-of-pocket insulin costs for Medicare: “CMS is capping out-of-pocket insulin costs for Medicare beneficiaries at $35 per month, the agency said May 26. 
More than 1,750 standalone Medicare Part D prescription drug plans will offer the lower insulin copays through the Part D Senior Savings Model for the 2021 plan year.”

About healthcare IT

COVID-19 contact tracing text message scams: This warning comes from the FTC and has examples of scams.

Money still makes the cyber-crime world go round - Verizon Business 2020 Data Breach Investigations Report is live: “Basic human error accounted for 31 percent of Healthcare breaches, with external breaches at 51 percent (up from 42 percent in the 2019 DBIR), slightly more common than insiders at 48 percent (59 percent last year). This vertical remains the industry with the highest number of internal bad actors, due to greater access to credentials.”

Today's News and Commentary

About the public’s health

FDA names 28 antibody tests to be taken off the market: “The 28 serology tests, mostly manufactured overseas, include ones that were voluntarily withdrawn by their sponsors as well as those that neglected to pursue an official FDA Emergency Use Authorization.
Under a policy in place from mid-March through early May, the agency allowed over 180 antibody blood tests to be sold and distributed in the U.S. without federal review but with certain conditions for manufacturers: They must notify the FDA of their plans, perform self-validation studies and carry a label saying the product is not authorized and incapable of diagnosing COVID-19 on its own.”

After Coronavirus, Office Workers Might Face Unexpected Health Threats: “Stagnant plumbing systems in emptied commercial buildings could put returning employees at risk of Legionnaires’ and other illnesses.”

Exclusive: A quarter of Americans are hesitant about a coronavirus vaccine - Reuters/Ipsos poll: “Fourteen percent of respondents said they were not at all interested in taking a vaccine, and 10% said they were not very interested. Another 11% were unsure.
…but experts estimate that at least 70% of Americans would need to be immune through a vaccine or prior infection to achieve what is known as ‘herd immunity,’ when enough people are resistant to an infectious disease to prevent its spread.”

U.S. Gives AstraZeneca $1.2 Billion to Manufacture COVID-19 Vaccine: The UK-based drugmaker [which has a joint venture with the University of Oxford] is partnering with HHS to make at least 300 million doses of the vaccine AZD1222. The funding will go toward development, production and delivery of at least 300 million doses.
The first doses are expected to be delivered as early as October.”

CDC estimates that 35% of coronavirus patients don't have symptoms: “The CDC also says its ‘best estimate’ is that 0.4% of people who show symptoms and have Covid-19 will die, and the agency estimates that 40% of coronavirus transmission is occurring before people feel sick.”

Scientists Warn CDC Testing Data Could Create Misleading Picture Of Pandemic: “The CDC combines the results of genetic tests that spot people who are actively infected, mostly by using a process known as polymerase chain reaction, or PCR, with results from another, known as serology testing, which looks for antibodies in people's blood. Antibody testing is used to identify people who were previously infected.” This mistake can cause authorities to miss a second spike in new cases. Such a mistake was one reason Toronto missed a second big peak during the SARS epidemic in 2003.

As States Start to Ease Coronavirus Restrictions, Few Americans Expect to Stay in Hotels or Fly This Summer, Though Most Plan to Visit a Doctor, Get a Hair Cut and Dine Out: This Kaiser Family Foundation poll revealed marked differences in behavioral attitudes between Democrats and Republicans. For example, 75% of Republicans said they would eat at a restaurant in the next 3 months, while the same response was only 39% for Democrats.

About healthcare costs

Milliman Medical Index [MMI]: Healthcare costs reach $6,553 for the average American, $28,653 for hypothetical family of four: “In 2020, healthcare costs for our hypothetical family of four reached $28,653. Healthcare costs for the average person are at $6,553. While these are averages, the MMI allows for greater specificity thanks to an interactive tool that was first released last year.”

About pharma

Gilead to start selling remdesivir in coming weeks, expects 'multi-year commercial opportunity': “The company will pivot to a commercial plan after the donated supply of 1.5 million doses runs out around June or early July…
The Institute for Clinical and Economic Review [ICER] recently found remdesivir would be cost-effective at $28,670 if the analysis used as a benchmark the common $100,000 per incremental quality-adjusted life-year gained. But the U.S. drug cost watchdog argued that $50,000/QALY should be applied to remdesivir during a public health emergency. After that calculation, ICER pegged a reasonable price at $4,460.”

Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis: “In summary, this multinational, observational, real-world study of [96,000] patients with COVID-19 requiring hospitalisation found that the use of a regimen containing hydroxychloroquine or chloroquine (with or without a macrolide) was associated with no evidence of benefit, but instead was associated with an increase in the risk of ventricular arrhythmias and a greater hazard for in-hospital death with COVID-19. These findings suggest that these drug regimens should not be used outside of clinical trials and urgent confirmation from randomised clinical trials is needed.” And yet…the President still insists his use is justified.

About health insurance

Trump Administration Announces Changes to Medicare Advantage and Part D to Provide Better Coverage and Increase Access for Medicare Beneficiaries: “The Centers for Medicare & Medicaid Services today finalized requirements that will increase access to telehealth for seniors in Medicare Advantage (MA) plans, expand the types of supplemental benefits available for beneficiaries with an MA plan who have chronic diseases, provide support for more MA options for beneficiaries in rural communities, and expand access to MA for patients with End Stage Renal Disease (ESRD).”

Today's News and Commentary

About the public’s health

Differential Effects of Intervention Timing on COVID-19 Spread in the United States: Here is the study reported in many media outlets today that calculates how many lives could have been saved if social isolation were implemented a week earlier. “Specifically, nationwide, 61.6% [95% CI: 54.6%-67.7%] of reported infections and 55.0% [95% CI: 46.1%-62.2%] of reported deaths as of May 3, 2020 could have been avoided if the same control measures had been implemented just one week earlier. We also examine the effects of delays in re-implementing social distancing following a relaxation of control measures. A longer response time results in a stronger rebound of infections and death.”

COVID-19: The CIDRAP Viewpoint: This third-in-a-series report is from the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. It is an excellent review of the process necessary for effective population testing and test interpretation for SARS-CoV-2. One major criticism is lack of systems coordination of all efforts. An important recommendation is that:
“The US secretary of Health and Human Services (HHS) should appoint by July 1, 2020, a blue- ribbon panel of national experts. The panel should include representatives from public health, clinical laboratory, and medicine; the laboratory testing research and development, marketing, and product support industries; ethicists; legal scholars; and elected officials. We have identified eight key objectives for the blue-ribbon panel to address.”

Majority of practices seeing patients in person again: “In a poll of more than 1,000 practice leaders conducted by the Medical Group Management Association  MGMA), 89 percent of practices surveyed indicated they were seeing patients in person again.” And a related article: The Impact of the COVID-19 Pandemic on Outpatient Visits: A Rebound Emerges, looks at actual patient volume increase.

Will government mandate COVID-19 vaccinations?: Recall that pre-COVID-19, many states were changing immunization requirements for children because of measles outbreaks. Now the question arises; When we have a vaccine for SARS-CoV-2, will vaccinations be mandated by federal/state/local governments?

‘It’s something I have never seen’: How the Covid-19 virus hijacks cells: “A deep dive into how the new coronavirus infects cells has found that it orchestrates a hostile takeover of their genes unlike any other known viruses do, producing what one leading scientist calls ‘unique’ and ‘aberrant’ changes.
Recent studies show that in seizing control of genes in the human cells it invades, the virus changes how segments of DNA are read, doing so in a way that might explain why the elderly are more likely to die of Covid-19 and why antiviral drugs might not only save sick patients’ lives but also prevent severe disease if taken before infection.”
The original article in Cell concludes: ”Cell and animal models of SARS-CoV-2 infection, in addition to transcriptional and serum profiling of COVID-19 patients, consistently revealed a unique and inappropriate inflammatory response. This response is defined by low levels of type I and III interferons juxtaposed to elevated chemokines and high expression of IL-6. We propose that reduced innate antiviral defenses coupled with exuberant inflammatory cytokine production [emphasis added]are the defining and driving features of COVID-19.”
In other words, SARS-CoV-2 reduces some antiviral responses while magnifying a harmful response.

Wuhan bans eating wild animals as coronavirus drives a crackdown in China: The headline speaks for itself. It took 2 pandemics (SARS and SARS-CoV-2) to make it happen.

HHS overrides states, lets all pharmacists give COVID-19 tests:”HHS decided May 19 that the Public Readiness and Emergency Preparedness, or PREP, Act preempts state laws restricting pharmacists' ability to order and administer COVID-10 diagnostic tests.”

How COVID-19 Spreads: This information is the latest CDC update. It emphasizes the primacy of person-to-person contact in transmission and measures to lessen that possibility.

Americans Who Rely Most on White House for COVID-19 News More Likely to Downplay the Pandemic: This research from the Pew Research Center for Journalism & Media is a MUST READ to gauge the harmful influence the White house has on dealing with the COVID-19 pandemic.

GOP fronts ‘pro-Trump’ doctors to prescribe rapid reopening:”Republican political operatives are recruiting “extremely pro-Trump” doctors to go on television to prescribe reviving the U.S. economy as quickly as possible, without waiting to meet safety benchmarks proposed by the federal Centers for Disease Control and Prevention to slow the spread of the new coronavirus. 
The plan was discussed in a May 11 conference call with a senior staffer for the Trump reelection campaign organized by CNP Action, an affiliate of the GOP-aligned Council for National Policy. A leaked recording of the hourlong call was provided to The Associated Press by the Center for Media and Democracy, a progressive watchdog group.”

Prostate Cancer Incidence 5 Years After US Preventive Services Task Force [USPTF] Recommendations Against Screening: “For all races/ethnicities combined, incidence for local-stage disease declined beginning in 2007 in men aged 50-74 and ≥75 years though the decline stabilized during 2013-2016 in men aged ≥75 years….In contrast, incidence for regional- and distant-stage disease increased in both age groups during the study period.” The USPTF had recommended eliminating routine PSA testing for men over 75. After that recommendation there was less early stage disease and more late stage disease. These findings raise the questions about the ability to pick up early disease and the high risk of false positives. The long-term solution would be a better test for prostate cancer.

Nasal Gene Expression of Angiotensin-Converting Enzyme 2 in Children and Adults: SARS-CoV-2 has an affinity for ACE2 receptors. This study of 305 people under age 60 shows an “age-dependent expression of ACE2 in nasal epithelium, the first point of contact for SARS-CoV-2 and the human body. Covariate-adjusted models showed that the positive association between ACE2 gene expression and age was independent of sex and asthma.” This finding may account for the fact that children account for less than 2% of identified cases of COVID-19.

READ: CDC reopening guidance: The latest version of this guidance.

Global regulators commit to cooperate on observational research in the context of COVID-19: At a conference co-organized by the European Medicines Agency (EMA) and Health Canada, international regulators agreed to enhance cooperation on three priority areas of observational research during the COVID-19 pandemic: pregnancy research, medicines used in clinical practice and vaccine safety and effectiveness monitoring.

About healthcare IT

Apple and Google launch contact tracing API for COVID-19 exposure: “Apple and Google's exposure notification application programming interface (API) will now be available to states, public health agencies and governments to build apps that will notify people via smartphone if they've come into contact with someone with the coronavirus…” The API became available yesterday “through a new software update in the Android and iOS operating systems…” This technology presumably can be used to track other illnesses, like influenza.

Different Approaches to a Coronavirus Vaccine: This article provides a really good explanation of the different methods being used to prepare vaccines.

Researchers: Nearly Half Of Accounts Tweeting About Coronavirus Are Likely Bots: Researchers at Carnegie-Mellon University “culled through more than 200 million tweets discussing the virus since January and found that about 45% were sent by accounts that behave more like computerized robots than humans. It is too early to say conclusively which individuals or groups are behind the bot accounts, but researchers said the tweets appeared aimed at sowing division in America.”

About pharma

7 things to know about startup drugmaker Phlow: As previously reported, “President Donald Trump this week signed a four-year, $345 million contract with Phlow, a little-known generic drugmaker that was founded less than six months ago, to manufacture drugs for the national medication stockpile.” This article provides more information about this company. In a related story, check: How Civica helped under-the-radar Phlow nab a $354M COVID-19 manufacturing deal.

Coverage for Biosimilars vs Reference Products Among US Commercial Health Plans: “This study found that, in 2019, US health plans covered biosimilars as preferred in only 14% of decisions. It also revealed biosimilar coverage differences across health plans. Reasons for this variation are unknown but may include more successful negotiation of rebates at some plans than others. Because rebate agreements are not publicly disclosed, however, it was not possible to examine this hypothesis empirically…The slow uptake of biosimilars in the US has been attributed to factors such as patent disputes and reference product manufacturer tactics to delay biosimilar market entry. This study suggests that a lack of preferred coverage among health plans may also be delaying uptake.”

About hospitals

States with the Highest Hospital Expenses: Considering that most of hospital costs are personnel and benefits, the order of states here is surprising.

100 great hospitals in America | 2020: The list is from Becker’s Healthcare.

Today's News and Commentary

About the public’s health

Fact-checking Trump’s letter blasting the World Health Organization: The headline is self-explanatory.

Location, location, location: This Castlight research found that: “More than half (54 percent) of America’s counties have zero COVID-19 testing sites. This testing shortfall is not limited to counties with very low populations. Of 1,176 metro counties, meaning they have a population above 50,000, 38 percent have zero testing sites.” Texas and Florida are given as examples and a chart provides data for all states.

Florida Ousts Top COVID-19 Data Scientist: “Rebekah Jones was the manager of the Geographic Information System team at Florida's Department of Health. She helped create a data portal that for months has provided easily accessible and detailed information on COVID-19 cases broken down by ZIP code. The Florida COVID-19 dashboard has been praised by researchers in the state and by Dr. Deborah Birx, the White House coronavirus task force coordinator.
Last week, Jones notified public health researchers in an email that she'd been removed from the project.”

States accused of fudging or bungling COVID-19 testing data: This article is the “other side” of the one above.

Study projects US COVID-19 deaths to triple by end of year:”A new study suggests the number of Americans who will die after contracting the novel coronavirus is likely to more than triple by the end of the year, even if current social distancing habits continue for months on end.
The study, conducted by the Comparative Health Outcomes, Policy and Economics Institute at the University of Washington's School of Pharmacy, found that 1.3 percent of those who show symptoms of COVID-19 die, an infection fatality rate that is 13 times higher than a bad influenza season.”

COVID-19 patients testing positive for second infection not contagious, study shows: “Researchers in Korea found evidence that patients who test positive for COVID-19 a second time aren't capable of infecting others, and may have neutralizing antibodies that protect them from getting sick again.”

Johnson & Johnson Stops Selling Talc-Based Baby Powder In U.S. And Canada: “Johnson & Johnson will stop selling talcum-based baby powder in the United States and Canada after being ordered to pay out billions of dollars related to lost legal battles over claims the product causes cancer.”

Roe v Wade: Woman behind US abortion ruling was paid to recant: “Norma McCorvey, known as Jane Roe in the US Supreme Court's decision on Roe v Wade, shocked the country in 1995 when she came out against abortion.  But in new footage, McCorvey alleges she was paid to switch sides.The documentary, AKA Jane Roe, airs this Friday on the US channel FX. The programme was filmed in the last months of McCorvey's life before her death at age 69 in 2017 in Texas…In her ‘deathbed confession’, as she calls it, a visibly ailing McCorvey says she only became an anti-abortion activist because she was paid by evangelical groups. ‘I was the big fish,’ she said. ‘I think it was a mutual thing. I took their money and they'd put me out in front of the cameras and tell me what to say.’”

U.S. Births Continue to Fall, Fertility Rate Hits Record Low: “The report on provisional data from the Centers for Disease Control and Prevention indicates notable birth and population measures reached record lows in 2019. American women, for example, are now projected to have about 1.71 children over their lifetimes – down 1% from 2018 and below the rate of 2.1 needed to exactly replace a generation.
’The (total fertility) rate has generally been below replacement since 1971 and consistently below replacement since 2007,’ the report says.”
These trends will have a profound effect on future funding of Medicare and Social Security, among other programs.

All 50 States Have Eased Coronavirus Restrictions: “All 50 states have begun to reopen in at least some way, more than two months after the coronavirus thrust the country into lockdown. But there remain vast discrepancies in how states are deciding to open up, with some forging far ahead of others.” This NY Times article surveys these changes and other COVID-19 topics.

About pharma

8 recent drug approvals: Good to see non-COVID-19 activity.

Today's News and Commentary

About the public’s health

Trump Threatens to Leave W.H.O. and Permanently End Funding: The president repeats this threat as HHS Secretary Azar rants against the WHO at the annual World Health Assembly.

Sweden’s Covid-19 strategy has caused an ‘amplification of the epidemic’: While Sweden’s open model has been touted by some US politicians, that country has fared more poorly than its neighbors with respect to COVID-19 control.

Long-acting injectable drug prevents HIV infections: “A long-acting antiretroviral drug given as an injection every 2 months powerfully protected uninfected people from HIV in a large-scale study that was disrupted by the COVID-19 pandemic. The apparent success—the study has not been published in a peer-reviewed journal or presented to HIV researchers at a meeting—offers a potentially easier alternative to taking daily pills of other antiretrovirals, which has proved difficult for many people.”

Medicaid Clinics And Doctors Have Been Last In Line For COVID-19 Relief Funding: ”In March, Congress authorized $100 billion for health care providers to compensate them both for the extra costs associated with caring for COVID-19 patients and for the revenue that's not coming in because of interruptions in the usual sorts of care they provide. more than half that money has been allocated by the Department of Health and Human Services, and the majority of it so far has gone to hospitals, doctors and other facilities that serve Medicare patients.
Officials said at the time that this was an efficient way to get the money beginning to move to large numbers of providers. That approach, however, has left out a large swath of the health system infrastructure that serves the low-income Medicaid population and children.”

Exclusive: CDC plans sweeping COVID-19 antibody study in 25 metropolitan areas: “The U.S. Centers for Disease Control and Prevention (CDC) plans a nationwide study of up to 325,000 people to track how the new coronavirus is spreading across the country into next year and beyond…The CDC study, expected to launch in June or July, will test samples from blood donors in 25 metropolitan areas for antibodies created when the immune system fights the coronavirus…”

WHO Director Says Even in Worst-Case Areas, Only About 20 Percent of Population Has Coronavirus Antibodies: “‘Early serology studies are painting a consistent picture: Even in the worst-affected regions, the proportion of the population with the telltale antibodies is no more than 20 percent," [WHO Director-General] Ghebreyesus said. ‘And in most places, less than 10 percent.’”

Global emissions plunged an unprecedented 17 percent during the coronavirus pandemic: “As covid-19 infections surged in March and April, nations around the globe experienced an abrupt reduction in driving, flying and industrial output, leading to a startling decline of more than a billion tons of carbon dioxide emissions. That includes a peak decline in daily emissions of 17 percent in early April, according to the study published in the journal Nature Climate Change. For some nations, the drop was much steeper.”

About pharma

Trump to Tap New Company to Make Covid-19 Drugs in the U.S.: “The Trump administration will announce on Tuesday that it has signed a $354 million four-year contract with a new company in Richmond, Va., to manufacture generic medicines and pharmaceutical ingredients that are needed to treat Covid-19 but are now made overseas, mostly in India and China.
The contract, awarded to Phlow Corp. by the Biomedical Advanced Research and Development Authority, meshes President Trump’s “America First” economic promises with concerns that coronavirus treatments be manufactured in the United States. It may be extended for a total of $812 million over 10 years, making it one of the largest awards in the authority’s history.”

Today's News and Commentary

About the public’s health

Moderna: Early coronavirus vaccine results are encouraging: “The vaccine by Cambridge, Massachusetts-based Moderna Inc., generated antibodies similar to those seen in people who have recovered from COVID-19 in study volunteers who were given either a low or medium dose.
In the next phase of the study, led by the U.S. National Institutes of Health, researchers will try to determine which dose is best for a definitive experiment that they aim to start in July.”

Targets of T cell responses to SARS-CoV-2 coronavirus in humans with COVID-19 disease and unexposed individuals: In order to be able to develop an effective vaccine, the body must be able to respond to an infection. This research confirms that, indeed, the body’s immune system is able to recognize SARS-CoV-2 and respond.

China has been trying to avoid fallout from coronavirus. Now 100 countries are pushing for an investigation: Today is the start of the annual World Health Assembly and it is expected that the WHO (which convenes the conference) will call for a summary of COVID-19 pandemic activities. Included is an investigation into whether China withheld early information. Also, see: Unprecedented World Health Assembly Convenes Online As Pandemic Rages

State and Federal Data on COVID-19 Testing Don’t Match Up: “ The CDC has quietly started releasing nationwide numbers. But they contradict what states themselves are reporting…
[D]ata sets have one known major difference: Some states report the total number of people tested, while the CDC reports every test, even if a single person is tested more than once. A spokesperson for Indiana’s public health department pointed to this difference to explain the state’s test gap. But our analysis suggests this—or any other methodological factor—does not fully explain the widespread discrepancies.”

As coronavirus testing expands, a new problem arises: Not enough people to test: “A Washington Post survey of governors’ offices and state health departments found at least a dozen states where testing capacity outstrips the supply of patients. Many have scrambled to make testing more convenient, especially for vulnerable communities, by setting up pop-up sites and developing apps that help assess symptoms, find free test sites and deliver quick results.
But the numbers, while rising, are well short of capacity — and far short of targets set by independent experts.”

Serological testing for SARS-CoV-2 antibodies: This article from the AMA is an excellent update on the types of tests, their drawbacks and recommendations for use and interpretation.

 HHS announces leadership team for Operation Warp Speed: The headline is self-explanatory.

Strong Social Distancing Measures In The United States Reduced The COVID-19 Growth Rate: Shelter-in-place orders (SIPOs) do work to reduce spread of SARS-CoV-2.
“Adoption of government-imposed social distancing measures reduced the daily growth rate by 5.4 percentage points after 1–5 days, 6.8 after 6–10 days, 8.2 after 11–15 days, and 9.1 after 16–20 days. Holding the amount of voluntary social distancing constant, these results imply 10 times greater spread by April 27 without SIPOs (10 million cases) and more than 35 times greater spread without any of the four measures (35 million).”

Fitbit plans to make emergency ventilators for Covid-19: The news is not that another company is making a ventilator. The CEO of Fitbit says that he “intends for the devices to be the ‘most advanced’ emergency user ventilator that’s still available at a ‘lower’ price point.” This product would be a true disruptive innovation- high quality, lower price and widely available. Shows that the market can rapidly change for the better.

Effect of Patient Portal Reminders Sent by a Health Care System on Influenza Vaccination Rates: Patient reminders are often cited as a means to increase recommended care. In this study, however, using reminders via patient portals were only “slightly effective in increasing influenza vaccination rates.” More intensive and targeted methods are recommended.

The online competition between pro- and anti-vaccination views:  This fascinating study from Nature performs opinion mapping regarding vaccine use employing a “global pool of around three billion Facebook users. Its core reveals a multi-sided landscape… that involves nearly 100 million individuals partitioned into highly dynamic, interconnected clusters across cities, countries, continents and languages. Although smaller in overall size, anti-vaccination clusters manage to become highly entangled with undecided clusters in the main online network, whereas pro-vaccination clusters are more peripheral. Our theoretical framework reproduces the recent explosive growth in anti-vaccination views, and predicts that these views will dominate in a decade. Insights provided by this framework can inform new policies and approaches to interrupt this shift to negative views.” Look at Figure 1 and notice how the antivax messages are right in the middle of the undecideds, while provax messages are at the periphery.

Fear Of Contracting Coronavirus Propels Some Smokers To Quit: The article is just a few anecdotes with no system-wide data. But it would be great if fear does motivate quitting.

About pharma

COVID-19-Related Medication Errors: This article highlights common, but easily fixed errors. The types of errors are not new- for example, getting the patient’s correct weight.

New Study Finds Hydroxychloroquine Provides No Benefit for COVID-19: Yet another study with this finding. This one is from France, from where the original treatment suggestion originated.

About healthcare IT

Most promising healthcare tech in 2020: 15 execs from CommonSpirit, Kaiser Permanente, UPMC & more: An interesting read with opinions from leading experts.

Apple, Google team up for COVID-19 tracing app & 16 other key notes: A really good summary of “who is doing what.”

CO Health Information Exchange Incorporates Medical Image Exchange: The COVID-19 pandemic has accelerated activities like this one. “CORHIO, a top health information exchange (HIE) in Colorado, has unveiled a partnership with a medical image exchange company to power the transfer of medical images between healthcare providers in the state.
Regardless of the health system or EHR system, the HIE can now facilitate images between its 19,000-plus users in Colorado.
Using this partnership, providers will be able to exchange MRIs, CT scans, ultrasounds, mammograms, and x-rays.”

About emerging science

Reprogramming a patient’s own skin cells to replace cells in the brain that are progressively lost during Parkinson’s disease has been shown to be technically feasible: ”The McLean-MGH team reprogrammed a 69-year-old patient’s skin cells to embryo-like pluripotent stem cells (called induced pluripotent stem cells) and then differentiated them to take on the characteristics of dopaminergic neurons, which are lost in Parkinson’s…In a series of two separate surgeries in 2017 and 2018 at Weill Cornell Medical Center and MGH, the patient underwent transplantation of the replacement dopamine neurons…As for how the patient feels, in the time that has passed since surgery, the patient has enjoyed improvements in his day-to-day activities and reports an improvement in his quality of life. Routine activities, such as tying his shoes, walking with an improved stride, and speaking with a clearer voice, have become possible again.”

Designing vaccines from artificial proteins: Ecole Polytechnique Fédérale de Lausanne scientists “developed a new computational approach to create artificial proteins, which showed promising results in vivo as functional vaccines. This approach opens the possibility to engineer safer and more effective vaccines.”

About health insurance

States face looming crisis over Medicaid growth, which could trigger changes for providers and payers: “States are about to face a major budget crisis due to exponential growth in Medicaid enrollment and a decline in tax revenue, which experts say could lead to provider payment cuts or other measures to contain costs.”

About hospitals

Hospitals Knew How to Make Money. Then Coronavirus Happened: A really good article with examples of how hospitals may have to shift from their money-making elective procedures to stay in business.

About healthcare professionals

Medscape Physician Compensation Report 2020: Lots of information in this study, including figures on decreased volume and revenue during the COVID-19 pandemic, specialty salary rankings (as usual, orthopedics is at the top and primary care/public health is at the bottom), as well as persistent sex differences in income.

Today's News and Commentary

About the public’s health

White House Announces Effort to Beef Up Strategic National Stockpile: Instead of having 1 to 3 weeks’ worth of supplies in the stockpile, the plan is to expand to 90 days, including a billion N95 masks.

CDC Issues Tools To Guide Reopening Of Schools, Businesses, Transit: The CDC issued flow chart-like documents for each category of institution considering reopening. For example, “all workplaces [should] hold off on reopening unless they are ready to protect employees at higher risk for severe illness, including those 65 and older and people of all ages with underlying medical conditions.”

U.S. Likely to Get Sanofi Vaccine First If It Succeeds: “Americans will likely get Sanofi’s Covid-19 vaccine before the rest of the world if the French pharmaceutical giant can successfully deliver one. That’s because the U.S. was first in line to fund Sanofi’s vaccine research, Chief Executive Officer Paul Hudson said in an interview with Bloomberg News.” The announcement provoked outrage by French officials. Sanofi replied that there will be enough vaccine available so its home country need not worry.

NYU study flags false negatives from Abbott's portable coronavirus test, while FDA lists concerns: A new study measuring the performance of Abbott’s rapid, point-of-care coronavirus test found the device could miss nearly half of positive cases, depending on how the samples were handled and fed into the machine [emphasis added].” Abbott says the specimens were not processed properly, for example, some of the nasal swabs were put in transport media, when they were supposed to be inserted directly into the testing machine.

U.S. to Accuse China of Attempts to Hack Coronavirus Research: “The Trump administration is planning to issue a warning that hackers tied to the Chinese government are attempting to pilfer information from U.S. researchers working on the race to develop a coronavirus vaccine, according to a person familiar with the matter.” While I know there have been numerous hacking events over the years, the reasons for this one doesn’t make sense. Academic papers and public media of research studies have been flowing freely. Further, this area is one in which all they should have to do is ask, as it benefits us to provide the information.

The Association of Energy and Macronutrient Intake at Dinner Versus Breakfast With Disease-Specific and All-Cause Mortality Among People With Diabetes: The U.S. National Health and Nutrition Examination Survey, 2003–2014: “Isocalorically replacing 5% of total energy at dinner with breakfast was associated with 4% and 5% lower risk of diabetes… and CVD [cardiovascular disease]…mortality, respectively.” In other words: “Higher intake of energy, total fat, and protein from dinner than breakfast was associated with greater diabetes, CVD, and all-cause mortality in people with diabetes.” The research recommends shifting calories from dinner to breakfast.

About health insurance

Employers Can Let Workers Change Health Plans Without Waiting: “Normally, strict rules prevent employees from changing health insurance plans in the middle of a year. But the I.R.S. is giving employers a way to let workers make changes without waiting for the usual enrollment period.
Under the new guidance, employers can let their workers drop out of their health insurance if they have another option, or sign up if they failed to earlier in the year. Workers could also be allowed to add more family members to their plan, or switch from one workplace plan to another.
The change doesn’t require employers to offer these options; they must opt in if they want to give their employees the added flexibility.”

About healthcare IT

Top 10 Routinely Exploited Vulnerabilities: The federal Cybersecurity and Infrastructure Security Agency (CISA) published this list. It is not exclusive to healthcare organizations, but useful nevertheless.

About pharma

Coalition of U.S. Attorneys Announce $15.3 Million Settlement With Omnicare, Inc., a CVS Health Company, For Improper Dispensing of Controlled Substances: The headline is self-explanatory.

NIH to test hydroxychloroquine, azithromycin combination as potential COVID-19 treatment : Given all the preliminary evidence of no effect (or harm), I wonder if politics is motivating this study.

Pfizer plans to farm out manufacturing for some of its drugs to make way for COVID-19 vaccine: “Pfizer plans to outsource production of some of its drug portfolio to make way for a rapidly growing vaccine manufacturing effort…
The drugmaker will lean on its 200-strong network of contractors as part of a plan to ‘build a robust U.S.-based supply chain as well as one based in Europe,’ a Pfizer spokesperson said.”

About healthcare professionals

Small medical practices struggle to survive amid coronavirus pandemic: “A survey done by a Richmond-based advocacy group for primary care doctors, called the Larry A. Green Center, found that half the doctors who sought such loans [Paycheck Protection Act loans] were unsuccessful. Of 2,774 doctors who responded to the survey, 19 percent said they had to temporarily close their practices because of financial problems; 42 percent had to lay off or furlough staff. About 10 percent say they will have to close in the next month because of financial shortfalls.” At a time when we need primary care physicians more than ever, lack of support is forcing them out of business. At best they will be forced into the empty of healthcare systems and take a pay cut.

The COVID-19 pandemic is influencing consumer health behavior. What does this mean for healthcare providers?: Many articles have commented that spending on and use of healthcare services have not only decreased during the COVID-19 pandemic but will continue after the crisis eases. This study by PwC’s Health Research Institute takes a deeper dive into public opinion and details projected behavior divided by market segments of health status and healthcare beliefs.

Today's News and Commentary

About the public’s health

Watch: Viral Japanese Video Shows How Quickly COVID-19 Can Spread At A Buffet: Fascinating!

The airborne lifetime of small speech droplets and their potential importance in SARS-CoV-2 transmission:”…loud speech can emit thousands of oral fluid droplets per second. In a closed, stagnant air environment, they disappear from the window of view with time constants in the range of 8 to 14 min, which corresponds to droplet nuclei of ca. 4 μm diameter, or 12- to 21-μm droplets prior to dehydration. These observations confirm that there is a substantial probability that normal speaking causes airborne virus transmission in confined environments.”

Inside the NIH’s controversial decision to stop its big remdesivir study: “The National Institute of Allergy and Infectious Diseases has described to STAT in new detail how it made its fateful decision: to start giving remdesivir to patients who had been assigned to receive a placebo in the study, essentially limiting researchers’ ability to collect more data about whether the drug saves lives — something the study, called ACTT-1, suggests but does not prove. In the trial, 8% of the participants given remdesivir died, compared with 11.6% of the placebo group, a difference that was not statistically significant.”

Waste in covid-19 research: A deluge of poor quality research is sabotaging an effective evidence based response: On the same theme as the above article, this BMJ editorial reviews the problems with current research activities.

How Virginia Juked Its COVID-19 Data: “A lack of federal guidelines has created huge variation in how states are reporting their COVID-19 data and in what kind of data they provide to the public.
These gaps can be used for political advantage. In at least one state, Virginia, senior officials are blending the results of two different types of coronavirus test in order to report a more favorable result to the public. This harms the integrity of the data they use to make decisions, reassure residents, and justify reopening their economies.”

Sugar‐Sweetened Beverage[SSB] Intake and Cardiovascular Disease [CVD] Risk in the California Teachers Study: “Consuming ≥1 serving per day of SSB was associated with CVD, revascularization, and stroke. SSB intake might be a modifiable dietary target to reduce risk of CVD among women.” Some drinks are worse than others: Compared to those who did not consume SSBs, those who drank fruit drinks with sugar added had a 42% greater likelihood of experiencing CVD while soda drinkers had a 23% greater likelihood. The article provides some possible mechanisms for this higher risk.

SARS-CoV-2 causes other, non-respiratory, illnesses: Here are a three examples:
1. An outbreak of severe Kawasaki-like disease at the Italian epicentre of the SARS-CoV-2 epidemic: an observational cohort study
2. Acute Kidney Injury in Patients Hospitalized with COVID-19
3.Infection of bat and human intestinal organoids by SARS-CoV-2

About health insurance

AHIP wants payers to offer a grace period for any surgeries canceled or postponed due to COVID-19: Pre-authorization for nonemergency surgeries are often good for a limited time. Since the COVID-19 pandemic has delayed many elective procedures, the insurance trade organization is calling on payers to to extend the time periods.

Coronavirus drives health insurers back to Obamacare: Many newly uninsured people are healthy, but lost coverage because they lost their jobs. This situation has created an opportunity for insurers to re-enter the health exchanges. For example: “United Healthcare, the nation’s biggest insurer, on Tuesday said it’s re-entering Maryland’s Obamacare market and planning other expansions after abandoning 34 states’ ACA exchanges since 2016.”

Today's News and Commentary

About the public’s health

Coronavirus Treatment Acceleration Program (CTAP): “The FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP).” This site provides information about how the FDA is streamlining its review and advice processes to expedite studies and implement results as quickly as possible.

Moderna's potential coronavirus vaccine gains FDA's 'fast track' status: “Moderna Inc said on Tuesday the U.S. Food and Drug Administration granted ‘fast track’ designation to its experimental coronavirus vaccine, a move that speeds up the regulatory review process…

A vaccine or treatment that gets the ‘fast track’ designation is eligible for the agency’s ‘priority review’ status, under which the FDA aims to take a decision on approving the drug within six months…
Moderna expects to start a late-stage study of the vaccine in early summer and says there is potential for a marketing application approval in 2021. 
The vaccine works on the messenger RNA (mRNA) technology…”

UV light robot destroys coronavirus in 2 minutes: “A machine that uses ultraviolet light to disinfect hospitals has been shown to deactivate the novel coronavirus in just two minutes, providing a potentially effective method of removing the virus from public spaces. 
Texas-based Xenex Disinfection Services recently announced a successful test of its LightStrike robot against the virus. The robot, sold in Japan by medical equipment maker Terumo, emits light of wavelengths between 200 and 315 nanometres to decontaminate beds, doorknobs and other surfaces.”

How Coronavirus Spreads through the Air: What We Know So Far: A good summary of the evidence so far…lots of “it depends” conditions.

Association Between Prenatal Exposure to Alcohol and Tobacco and Neonatal Brain Activity: Results From the Safe Passage Study: Even low levels of prenatal alcohol exposure (PAE) and prenatal tobacco exposure (PTE) are associated with changes in offspring brain development. In other words, there is no safe level of consumption.

About pharma

How Civica Rx has responded to drug shortages caused by COVID-19:”Civica Rx was formed to combat drug shortages, which have become a prominent issue as the COVID-19 pandemic exhausts hospital supplies around the country. 
The nonprofit generic drug company was formed in 2018 by seven major health systems with the goal of preventing drug shortages. Today it works with U.S. 1,200 hospitals.
Civica has launched 20 drugs that it supplies to hospitals, and it plans to add another 20 drugs to the list this year. By 2023, the company hopes to provide 100 drugs…
Hospitals tell Civica which drugs they need, and Civica then works with generic drugmakers to manufacture and stock up on the drugs, which it keeps in warehouses. It keeps about six months' worth of drug inventory in warehouses for its hospital partners to access whenever needed…” Filling shortages is particularly important now. See: Pandemic exposes drug supply shortages doctors have grappled with for "more than two decades"

About hospitals

17 states where hospitals are largest employers: This article emphasizes the economic importance of hospitals in addition to their essential provision of healthcare.

About health insurance

More than 20M of newly unemployed could qualify for ACA tax credits: “As unemployment continues to skyrocket due to COVID-19, a new analysis shows that more than 20 million people losing job-based insurance could get a tax credit on the Affordable Care Act’s (ACA's) insurance exchanges.
But nearly 6 million people will not be eligible for such credits and must pay the full cost of coverage, according to the analysis from the Kaiser Family Foundation released Wednesday.”

Proportion of Racial Minority Patients and Patients With Low Socioeconomic Status Cared for by Physician Groups After Joining Accountable Care Organizations: “In this cohort study, there were no changes in the proportions of vulnerable patients cared for by ACO-participating physician groups after joining an ACO compared with changes among nonparticipating groups.” The participating ACO patients were in a Medicare Shared Savings Program.
While the results seems to be “good news,” it would be surprising if they were otherwise. Recall patients are assigned to primary care physicians by the last Evaluation and Management codes billed to Medicare. In many, if not most, cases, physicians do not know if a patient belongs to an ACO. Further, physicians may not have any financial incentives to care for lower risk patients.

Today's News and Commentary

About the public’s health

Fauci tells Congress that states face serious consequences if they reopen too quickly: Here is the video of his comments as well as written details. The headline is the bottom line of the message.

The ‘biggest challenge’ won’t come until after a coronavirus vaccine is found: Once a vaccine against SARS-CoV-2 is found, many other problems will prevent widespread dissemination through the supply chains, starting with manufacturing on a massive scale. The article argues we are unprepared to conduct those processes.

Wuhan To Test All 11 Million Residents After New Coronavirus Cases Emerge: “The Chinese city of Wuhan will begin what it is calling "10 days of mass battle" to test all 11 million residents after the discovery of a new cluster of coronavirus cases…” They can test 11 million people? Perhaps we are not the most prepared nation as the President insists.

White House pushes states to test 2 percent of their populations for coronavirus: On the same theme as the above article, this goal would achieve testing for 12.9 million people. Not only is the percent too low, it does not take into account needed retesting. The Wuhan testing is its second round.

Becoming ‘King of Ventilators’ may result in unexpected glut: Due to the ramped up production and changes in treatment protocols, our country has more than enough ventilators, given current disease projections. This article is a good summary of what happened and is happening to supplies of this product.

Identification and Monitoring of International Travelers During the Initial Phase of an Outbreak of COVID-19 — California, February 3–March 17, 2020: This CDC analysis of feasibility and success/failure of traveler screening provides broader insights into this method of disease containment.
”Despite intensive effort, the traveler screening system did not effectively prevent introduction of COVID-19 into California. Incomplete traveler information received by federal officials and transmitted to states, the number of travelers requiring follow-up, and the potential for presymptomatic and asymptomatic transmission likely contributed to onset of community transmission and the need to shift to mitigation measures.”

About health insurance

CMS pitches increase in inpatient rates, new payment category for CAR-T: “The Trump administration proposed changes for acute care and long-term care hospitals Monday, including an approximately 1.6% increase to inpatient hospital stay payments.
The Centers for Medicare & Medicaid Services (CMS) announced the payment adjustment, which could also include potential penalties for excess readmissions. The change is expected to increase total Medicare spending on inpatient hospital services by about $2.1 billion in the fiscal year beginning in October….
The proposed changes also include creating a new hospital payment category for chimeric antigen receptor (CAR) T-cell therapy it says would provide a predictable rate to hospitals offering the treatment.”

Florida pharmacists charged in $87M Tricare scheme: The headline is self-explanatory. When was the last time a private payer was hit by such a level of fraud?

About pharma

Association of Treatment With Hydroxychloroquine or Azithromycin With In-Hospital Mortality in Patients With COVID-19 in New York State: Yet another study rebutting effectiveness of this regimen: “Among patients hospitalized with COVID-19, treatment with hydroxychloroquine, azithromycin, or both was not associated with significantly lower in-hospital mortality.”

Gilead inks deals with generics makers to supply COVID-19 therapy remdesivir for 127 countries: “Gilead will work with Cipla, Mylan, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences to manufacture the drug primarily for low- and lower-middle income countries. The list also includes higher-income countries "that face significant obstacles to healthcare access…”

About healthcare technology

Mass General Brigham: 12 disruptive innovations in healthcare: “Mass General Brigham named 12 technologies and innovations that will have the most significant effect on healthcare through the end of 2021 based on interviews with Harvard faculty.” Do you agree? What’s on YOUR list?

Today's News and Commentary

About the public’s health

Canadian study finds temperature, latitude not associated with COVID-19 spread: “A new study finds that temperature and latitude do not appear to be associated with the spread of coronavirus disease 2019 (COVID-19), but school closures and other public health measures are having a positive effect.” Humidity had a weak association with spread. The findings are significant, since many policy makers are predicting the warm summer weather may slow SARS-CoV-2 transmission.

How Climate Change Is Contributing to Skyrocketing Rates of Infectious Disease: An excellent article that describes how destruction of biodiversity enhances more rapid emergence of diseases that will affect humans. An interesting (staggering) statement- “One study estimates that more than 3,200 strains of coronaviruses already exist among bats, awaiting an opportunity to jump to people.”

The "Pill" at 60: promises unkept — unintended pregnancies must still be stamped out: Saturday was the 60th anniversary of the FDA’s approval of the first birth control pill. “Six decades later, however, the ‘pill’ has yet to deliver on its warrant to render unintended pregnancies a thing of the past. Nearly half of all pregnancies in the United States are still unintended.”

Triple combination of interferon beta-1b, lopinavir–ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial: The triple therapy reduced the median number of days to a negative test result from 12 to 7, compared with a control group that only received lopinavir-ritonavir. However, the “trial was open label, without a placebo group, and confounded by a subgroup omitting interferon beta-1b within the combination group, depending on time from symptom onset.”

U.S. FDA authorizes first at-home saliva test for COVID-19: “The U.S. Food and Drug Administration said on Friday it has authorized the first diagnostic test for the new coronavirus that allows patients to collect saliva samples at-home.” The test costs $150 and must be mailed to a commercial lab.

Abbott Says Research Confirms Accuracy of COVID-19 Antibody Test: The test has “high specificity” and 100% sensitivity. But the figures are for tests done 17 days or more after symptoms began.

Schumer calls on VA to explain use of unproven drug on vets: “Sen. Charles Schumer of New York said the VA needs to provide Congress more information about a recent bulk order for $208,000 worth of hydroxychloroquine.” The problem is that the drug probably does not work in COVID-19 treatment.

About hospitals

National Patient and Procedure Volume Tracker: This report details which hospital departments were hardest hit by the elective procedure slowdown. Ophthalmology leads the list at 81%.

About pharma

Generic Pharmaceutical Company Admits to Fixing Price of Widely Used Cholesterol Medication: “According to the one-count felony charge filed in the U.S. District Court for the Eastern District of Pennsylvania in Philadelphia, Apotex and other generic drug companies agreed to increase and maintain the price of pravastatin, a commonly prescribed cholesterol medication that lowers the risk of heart disease and stroke.  The conspiracy began in May 2013 and continued through December 2015.” The criminal penalty is $24.1 million.

Today's News and Commentary

About the public’s health

Commemorating the 40th Anniversary of Smallpox Eradication: Finally, something to celebrate. Today, the WHO celebrates the 40th anniversary of the eradication of smallpox. “Smallpox is the first and only disease to be permanently eradicated worldwide. Until it was wiped out, smallpox had plagued humanity for at least 3 000 years, killing 300 million people in the 20th century alone, that is 4 million people annually.  
In 1967, WHO launched the 10‐year Intensified Smallpox Eradication Programme to concentrate on endemic countries.” It is a model of a public health initiative.

HRSA Provider Relief Fund – General Allocation: Check this site to see the amounts healthcare organizations received under the CARES Act and the Paycheck Protection Program and Health Care Enhancement Act. The list is organized by state.

EUA Authorized Serology Test Performance: On the heels of the FDA announcement that it is more carefully evaluating SARS-CoV-2 tests, it approved 12 of them. This site provides the details. The problem is that predictive values (positive and negative) depend on the disease’s prevalence, which is unknown and can vary by geography. Check this site for the FDA calculator for predictive values given certain sensitivity, specificity and prevalence. It also calculates those values if you use two tests.

About healthcare IT

Congress must tackle patient matching amid COVID-19, says Pew Charitable Trusts: If we want to do meaningful disease tracing, we need unique patient identifiers. This problem is long overdue to be addressed and now has a compelling reason to finally resolve it.

About health insurance

Wide State-Level Variation In Commercial Health Care Prices Suggests Uneven Impact Of Price Regulation: “…we found that average commercial prices for inpatient and outpatient facility services were about double Medicare fees, while commercial prices for professional services were about 60 percent higher. Finally, average hospital revenue would fall about 35 percent if commercial prices were limited to Medicare rates, but this would vary widely by state. If Medicaid rates were also increased to match Medicare rates, hospital revenue would likely fall by about 30 percent.”

CMS Announces Final Payment Notice for 2021 Coverage Year: Lots of information about ACA exchange plans. One of the most controversial has been whether patients can count coupons for drugs toward annual deductibles or out of pocket limits. The final rule language is a bit confusing. It seems to say the insurer can, but is not obligated, to allow this practice. Here is the language:

“…we are revising § 156.130(h) to state that, to the extent consistent with applicable state law, amounts paid toward reducing the cost sharing incurred by an enrollee using any form of direct support offered by drug manufacturers for specific prescription drugs may be, but are not required to be, counted toward the annual limitation on cost sharing. However, we are not finalizing any change to the definition of cost sharing.”

Today's News and Commentary

About pharma

Physicians criticize remdesivir distribution process: “Physicians are criticizing the government's distribution of remdesivir, Gilead's drug that received emergency authorization from the FDA May 1 to treat COVID-19, saying the government isn't prioritizing the hospitals that need the drug most…
So far, about two dozen hospitals have reportedly been selected by the government to receive remdesivir. But it's unclear how the government is deciding which hospitals get the drug and which part of the government is making the decisions.”

Cholesterol lowering drugs – statins – are linked to improved gut bacteria composition in obese people : Interesting science: ‘Statins are commonly prescribed to reduce risk of developing cardiovascular diseases like myocardial infarction and stroke…Besides their cholesterol-lowering effects, statins also tend to appease patients' systemic inflammation levels which in part may be related to a disrupted gut microbiota… statins could potentially modulate the disrupted gut microbiota and linked inflammation in obesity.”

About the public’s health

AP Exclusive: US shelves detailed guide to reopening country: “The 17-page report by a Centers for Disease Control and Prevention team, titled “Guidance for Implementing the Opening Up America Again Framework,” was researched and written to help faith leaders, business owners, educators and state and local officials as they begin to reopen. 
It was supposed to be published last Friday, but agency scientists were told the guidance ‘would never see the light of day,’ according to a CDC official. The official was not authorized to talk to reporters and spoke to The Associated Press on the condition of anonymity.”

About health insurance

Blue states file opening salvo in Supreme Court battle over ACA: With all the COVID-19 news we forget other important healthcare issues are being played out. The Supreme Court is starting to hear arguments over whether the ACA should be repealed in its entirety because the penalty for not being insured is now $0. Also, despite yesterday’s story about AG Barr’s recommendation not to invalidate the entire law, the Trump administration is planning to continue its present course, favored but Republican states’ attorneys general.

UnitedHealth Group to Provide Over $1.5 Billion in Assistance and Premium Support to Customers: United joins other insurers in providing financial relief to members: “UnitedHealth Group will provide more than $1.5 billion in initial assistance, including customer premium credits, to its UnitedHealthcare customers as many people have been unable to access routine or planned care due to the COVID-19 pandemic. Consequently, UnitedHealthcare has seen a lower volume of medical care being delivered than was anticipated when pricing was initially established.
For UnitedHealthcare commercial fully insured individual and employer customers, credits ranging from 5% to 20% -- depending upon the specific plan -- will be applied to premium billings in June.”

Today's News and Commentary

About the public’s health

Researchers hypothesize that a highly contagious strain of the coronavirus is spreading, but other experts remain skeptical: This article updates the one yesterday that was originally published in the LA Times. Not all infectious disease experts are accepting the theory that a mutation in SARS-CoV-2 is responsible for its rapid spread.

Researchers Hope New CRISPR Technique Could Speed Up Coronavirus Testing: This simple test from MIT would cost about $6.

Israeli research team gets a step closer to developing a Covid-19 vaccine: “Israel's Defense Ministry said that the Israel Institute for Biological Research (IIBR) has completed the development phase of a coronavirus antibody or passive vaccine…
Meanwhile, a second Israeli research team, MigVax, has also reported that it is close to completing the first phase of development of a coronavirus vaccine.”
These initiatives appear to be far ahead of any others in development.

Cardiovascular groups share joint guidance on continuation of procedures, diagnostic tests during COVID-19 pandemic: Healthcare providers are setting the conditions under which they can safely return to providing non-urgent services. This article is one example of this effort. “A group of cardiovascular societies, including the American College of Cardiology (ACC) and American Heart Association (AHA), has published a new guidance designed to help providers resume important procedures and diagnostic tests during the COVID-19 pandemic.”

Task force will continue: The day after media reports about the closing of the Covid-19 task force, the President’s morning tweet said:” …the Task Force will continue on indefinitely with its focus on SAFETY & OPENING UP OUR COUNTRY AGAIN.”

U.S. traffic deaths fell in 2019 for third straight year: Some good news: “The National Highway Traffic Safety Administration (NHTSA) reported an estimated 36,120 people died in motor vehicle traffic crashes last year, down 1.2% from 36,560 in 2018, even as travel rose 0.9% to 3.23 trillion miles.”

About pharma

CVS Health reports first quarter results, provides update on COVID-19 response: Not every business has been adversely affected bu Covid-19. CVS reported first quarter total revenues increased 8.3% to $66.8 billion and GAAP operating income increased 28.6% to $3.5 billion. The full year earnings per share guidance was unchanged.

AbbVie and Allergan Receive Clearance from U.S. Federal Trade Commission for AbbVie's Acquisition of Allergan: This press announcement gives details for the $63 billion deal.

Pharmaceutical Shipping Costs Spike in Response to Global COVID-19 Pandemic: “The survey of AAM’s [Association for Accessible Medicines] generic and biosimilar drug manufacturers revealed that travel and transport costs have skyrocketed 224% on average, with at least one manufacturer reporting as much as a 413% increase in shipping expenses compared to the same costs before the crisis…
As a result of the global slowdown and restrictions placed on international air travel resulting from the coronavirus pandemic, there has been a dramatic reduction in airline flights that carry pharmaceuticals and available cargo capacity. Government mandated work from home orders, along with unpredictable trade and export restrictions, have further exacerbated the difficulties supplying medicines during a time of significantly increased demand for treatments.”

About health insurance

Humana waives cost-sharing for primary care, behavioral health visits through end of 2020: Health plans are waiving some out of pocket expenses for members. For example,” Humana will now waive all cost-sharing for in-network primary care and behavioral health care visits through the end of the year for its Medicare Advantage members.”
But I am not sure exactly how it would work (none of the reports, including this one, go into detail). 
For example, if copays are waived, does the health plan make up that amount in provider payments? Likewise, if the patient is not responsible for the deductible or coinsurance, does that mean providers will not have that amount deducted from their payments?
The implication is that insurers may seem to be “doing good” while shifting the financial burden to already-stressed providers.

Barr urges Trump administration to back off call to fully strike down Obamacare: “According to four sources familiar with the meeting, Barr argued for modifying the administration's current stance to preserve parts of the law, rather than fully back the lawsuit filed by a group of Republican states. As it stands now, the Trump administration's position seeks to invalidate the entire Affordable Care Act, signed by President Barack Obama in 2010 and commonly known as Obamacare.”

Report Card on State Price Transparency Laws : “A total of 34 states received failing letter grades because they either did not have an APCD [All-Payer Claims Database] or they did not mandate consumer-friendly, public-facing price transparency websites.” Only Maine and New Hampshire received an “A.”

Toady's News and Commentary

About pharma

Exclusive: AmerisourceBergen eyes Walgreens' drug distribution business: “AmerisourceBergen Corp, one of the largest U.S. drug distributors, has approached Walgreens Boots Alliance Inc to explore a deal for its pharmaceutical wholesaling division, people familiar with the matter said on Monday.
Walgreens owns about 27% of AmerisourceBergen and is its biggest customer.”

About hospitals

Dramatic GDP Reduction Reflects Unprecedented Financial Stress on U.S. Hospitals: From the Federation of American Hospitals: “According to the U.S. Bureau of Economic Analysis (BEA), this drop in health care spending is a driving force behind the estimated 4.8% decrease in Gross Domestic Product (GDP) in the first quarter of 2020. The decline in hospital revenues during this period represents the most drastic reduction in recorded history …”

About the public’s health

French hospital discovers country's first known Covid-19 case, from December: “Yves Cohen, head of resuscitation at the Avicenne and Jean Verdier hospitals in the northern suburbs of Paris, told French media that scientists had retested samples from 24 patients treated in December and January who tested negative for the flu.
’Of the 24, we had one who was positive for Covid-19 on Dec. 27," he told the news channel on Sunday.”
Latest epidemiology seems to show that the US was exposed not only from China but from Europe as well. See the next story.

A mutant coronavirus has emerged, even more contagious than the original: “The new strain appeared in February in Europe, migrated quickly to the East Coast of the United States and has been the dominant strain across the world since mid-March…” It may be a different strain than the one in Wuhan, which is worrisome since current treatments and vaccine development are based on a stable virus.

'It makes no sense': Feds consider relaxing infection control in US nursing homes:”The federal government is considering rolling back infection control requirements in U.S. nursing homes – even as the long-term-care industry's residents and workers are overwhelmed by the coronavirus… The regulation has not been finalized, but CMS last week defended its proposal, saying it aims to reduce regulatory burden and strengthen infection control.” How smart is that????

About health insurance

How the COVID-19 Recession Could Affect Health Insurance Coverage: This report from the Urban Institute projects the health insurance consequences of a 20% unemployment rate: “Findings include:

  • An estimated 25-43 million people could lose their employer-sponsored health insurance coverage.

  • More than half of the newly jobless will obtain Medicaid coverage in states that expanded Medicaid under the Affordable Care Act (ACA), while only about one-third will receive Medicaid coverage in the 15 states that have not expanded the program.

  • Less than a quarter of these workers and their dependents in expansion states will become uninsured, while about 40 percent in non-expansion states will become uninsured.”

Today's News and Commentary

About the public’s health

Pence: 'I Should Have Worn A Mask' When Visiting The Mayo Clinic: Not quite an apology, he said: "I didn't think it was necessary, but I should have worn a mask at the Mayo Clinic." 

Cost of vaccinating billions against Covid-19 put at more than $20bn: “International health organisations suggest the full cost could reach $25 billion, once funding needed to manufacture doses in vast quantities and distribute them globally is taken into account.”

FDA steps up scrutiny of coronavirus antibody tests to ensure accuracy: As previously noted, due to the pressure for results, oversight of SARS-CoV-2 tests has been lax. Now that more than 100 assays are on the market, the FDA is scrutinizing their effectiveness.

We aren’t piling on pounds in lockdown, digital scale maker finds: “Despite concerns about gaining a ‘quarantine 15,’ the average user [of a web-enabled scale] gained 0.21 pounds during that month. Some 37 percent of people gained more than a pound.
How you view those numbers, however, is a matter of perspective. In a typical year, Americans gain one to two pounds.” In part, more selective food purchasing has been given as a reason for this finding.

Why The U.S. Government Stopped Funding A Research Project On Bats And Coronaviruses: The decade-long support of early detection efforts was terminated when the White House found out that some of the funds were going to the Wuhan Institute of Virology.

White House and Congress clash over liability protections for businesses as firms cautiously weigh virus reopening plans: Republicans want employers to be shielded from liability for COVID-19 infections when employees come back to work, provided government guidelines are followed. The Democrats do not want to grant protection. Wonder what the role is of trial lawyers in this struggle.

About health insurance

Coronavirus Florida: Some Medicare Advantage plans allow for mask purchases: “Medicare Advantage members can use their benefits to purchase over-the-counter items such as masks and other personal protective gear in demand during the COVID-19 pandemic.
Depending on the plan, this may include disposable gloves, hand sanitizer, masks and antiseptic wipes.”

White House to Replace HHS Inspector General: “President Trump is replacing the inspector general [Christi Grimm] at the Department of Health and Human Services (HHS) several weeks after she issued a report critical of the administration's efforts in fighting the COVID-19 pandemic.
In a little-noticed announcement Friday evening, Trump nominated Jason Weida, an assistant U.S. attorney in Boston, for the post. The nomination must be approved by the Senate.”

About pharma

Fair price for Gilead's COVID-19 med remdesivir? $4,460, cost watchdog says: “…the Institute for Clinical and Economic Review (ICER)—which routinely weighs in on drug costs—says the drug is cost-effective at $4,460 per course of treatment.
Even at $1,000 per patient, less than a quarter of ICER's fair price, Gilead could rake in $1 billion in sales this year…”

Prices and clinical benefit of cancer drugs in the USA and Europe: a cost–benefit analysis: “The median monthly treatment costs for the included cancer drugs were $13179 … in the USA, $6206… in England, $5696… in Switzerland, $5121… in Germany, and $4866… in France…
Cancer drug costs per month in the USA were a median of 2·31 times as high as their corresponding median costs in the four European countries considered…. In repeated measure analyses of the 46 drugs approved for solid tumours with data pooled across all assessed countries, we found no significant difference in monthly treatment costs between drugs with high clinical benefit compared with low benefit…”
Yes, it’s the prices!

The top pharma companies in social media: Researchers at Ogilvy Health developed a scale to measure pharma companies’ performance on social media. They explain the process thusly: ““In the early days, it was all about the big numbers: who had the largest community of followers, which social page achieved the greatest number of favorites or likes. But the paid social model now means that it’s less about having the biggest following and more about using the sophisticated targeting capabilities of social advertising to reach the right audience at the right time. Through promotion you can ensure a greater number of people see your posts, or even drive more ‘likes’, but does this really make a difference to your business and how the world views your company?” Read the article for an explanation of the criteria specifics and how the 15 rated companies performed.

About hospitals

Data shows U.S. hospitals are losing $1.4B in daily revenue, due to patient volume decline: The headline is self explanatory. It highlights the profitability of elective surgical procedures.

U.S. hospitals promise new safety measures to ease patient fears after coronavirus crush: The article emphasizes that safety measures put into effect for COVID-19 are likely to remain after the disease subsides- from plexiglass barriers to telemedicine.

About healthcare IT

Epic, Meditech gain U.S. hospital market share as other EHR vendors lose ground: The headline speaks for itself. “Epic and Cerner now have more than 50% market share of the acute care market. Combined with Meditech, they control close to 75% of the market.”

Today's News and Commentary

About the public’s health

FDA grants emergency authorization to drug that showed promise in treating covid-19, Trump says: “The FDA issued an emergency use authorization for Gilead Sciences’s antiviral drug remdesivir for patients hospitalized with a severe case of covid-19.”

Three-fifths of new coronavirus cases in China show no symptoms: “A Financial Times analysis of the more complete data into Covid-19 that the Chinese government began publishing at the start of April found that 60 per cent of confirmed cases recorded over the past month were non-symptomatic at time of testing.” This finding has significant public health implications, since these people can easily spread the disease.

Structural Basis for Potent Neutralization of Betacoronaviruses by Single-domain Camelid Antibodies: Llamas (and other members of the camelid family) have two types of antibodies, those similar to humans and much smaller ones called single-domain antibodies or “nanobodies.” Researchers at the University of Texas are exploring these later versions for their ability to attack the spikes on coronavirus that are necessary for cellular attachment.

Trump Administration Issues Second Round of Sweeping Changes to Support U.S. Healthcare System During COVID-19 Pandemic: The first interesting thing about this “article” is that it is an official announcement from CMS, yet Trump appears in the headline.
This announcement has many different provisions so you will need to read the entire document to get the full message. Examples include:

  • To help ensure that Medicare beneficiaries have broad access to testing related to COVID-19, a written practitioner’s order is no longer required for the COVID-19 test for Medicare payment purposes.

  • CMS is giving providers flexibility during the pandemic to increase the number of beds for COVID-19 patients while receiving stable, predictable Medicare payments. 

  • CMS is highlighting flexibilities that allow payment for outpatient hospital services -- such as wound care, drug administration, and behavioral health services -- that are delivered in temporary expansion locations, including parking lot tents, converted hotels, or patients’ homes (when they’re temporarily designated as part of a hospital).

  • Nurse practitioners, clinical nurse specialists, and physician assistants can now provide home health services, as mandated by the CARES Act. These practitioners can now (1) order home health services; (2) establish and periodically review a plan of care for home health patients; and (3) certify and re-certify that the patient is eligible for home health services. Previously, Medicare and Medicaid home health beneficiaries could only receive home health services with the certification of a physician. These changes are effective for both Medicare and Medicaid.

  • CMS will not reduce Medicare payments for teaching hospitals that shift their residents to other hospitals to meet COVID-related needs, or penalize hospitals without teaching programs that accept these residents.

NIH begins taking pitches for its $1.5B COVID-19 diagnostics competition: “The National Institutes of Health kicked off what it describes as a ‘Shark Tank’-like effort to select and fund new diagnostic tests for the novel coronavirus, and its offering a total of $1.5 billion to be divvied up among the winners. 
The Rapid Acceleration of Diagnostics initiative, or RADx, aims to fast track companies’ validation, regulatory review and production, with the goal of delivering millions of at-home or point-of-care tests per week to the public by the end of the summer.”

A SARS-CoV-2 protein interaction map reveals targets for drug repurposing: If you are interested in the basic science of SARS-CoV-2, this article from Nature provides potential targets and drug candidates to attack the virus.

The Future of the COVID-19 Pandemic: Lessons Learned from Pandemic Influenza: The Center for Infectious Disease Research and Policy (CIDRAP) predicts that SARS-CoV-2 is likely to keep spreading for at least another 18-24 months, until there is some “heard immunity,” with about 60% to 70% of the population having been infected. In a worst-case scenario there will be a second wave of infections in fall and winter.

About healthcare quality and safety

Leapfrog Hospital Safety Grade: This announcement is the semiannual report that grades hospitals on safety. You can look up individual institutions. Very few received “A” grades for all measures.

About health insurance

Estimating the impact of COVID-19 on healthcare costs in 2020: Key factors of the cost trajectory: As previously explained, COVID-19 costs will be the net of an increase from treating the disease less savings from postponement of elective procedures. The actuarial firm, Milliman, projects “a net reduction in medical costs for healthcare payers by at least $75 billion and as much as $575 billion if the deferral and elimination of care continues through the end of 2020.”

Financial updates from Cigna, Anthem, Centene & Humana: Basically, revenue is up and net earnings are down- but no losses.

About healthcare IT

As coronavirus strikes, crucial data in electronic health records hard to harvest: Pooling ”data from the digital records systems in thousands of hospitals has proved a technical nightmare thus far. That’s largely because software built by rival technology firms often cannot retrieve and share information to help doctors judge which coronavirus treatments are helping patients recover.” That’s the price of not creating a national standard for interoperability when Meaningful Use was enacted.

Today's News and Commentary

About the public’s health

Senate Dems unveil bill to federalize medical supply chain, boost production: “The legislation would establish a new executive officer to oversee the production of supplies and who would issue reports every week on the supplies that are needed in the fight against the coronavirus. The officer would then be required to issue purchase orders under the Defense Production Act for those needed supplies and oversee their distribution.” Since it is a Democratic initiative, the chances of passage are slim. Below is a similar Republican proposal.

Trump administration launches 'Operation Warp Speed' to accelerate vaccine development: “The Trump administration is pushing agencies to speed up the vaccine development process in the hopes of quickly coming up with an effective way to guard against the coronavirus, two people familiar with the effort confirmed Wednesday.
The push, dubbed ‘Operation Warp Speed,"‘involves the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), among other government agencies, according to one official.”

Germany’s First COVID-19 Vaccine Trial Gets Under Way: Perhaps we won’t have to wait 18 months or so. “Twelve participants were dosed with BNT162 since dosing began on April 23. Approximately 200 healthy subjects will be assessed to determine the vaccine’s safety and the patients’ immune response as well as the optimal dose for further studies.
Participants with a higher risk of severe COVID-19 infection will be included later in the study.”

Dogs are being trained to sniff out coronavirus cases: The headline is self-explanatory, and yes, this story is real.

About pharma

FDA will reportedly authorize use of remdesivir for Covid-19 after trial shows 'positive effect' on recovery time: This article is a followup on yesterday’s post. “‘The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,’ Dr. Anthony Fauci said at the White House during a meeting with President Donald Trump.”

Remdesivir: Five things to know about the antiviral drug: Good overview from the Financial Times (restricted access).