Today's News and Commentary

About pharma

NIAID-led trial shows Gilead's remdesivir speeds up recovery in advanced COVID-19: “Early data from the Phase III ACTT trial led by the US National Institute of Allergy and Infectious Diseases (NIAID) indicate that hospitalised patients with advanced COVID-19 given Gilead Sciences' remdesivir had a 31% faster time to recovery than those on placebo.”

Top 15 specialty pharmacies by revenue: FYI: Here are the top 4- revenue drops considerably after.

1. CVS Specialty — $43.9 billion

2. Accredo/ Freedom Fertility — $32.1 billion 

3. AllianceRx Walgreens Prime/ Walgreens stores — $21.2 billion 

4. Optum Specialty Pharmacy  — $17.8 billion 

California fines more than a dozen drug makers for not providing drug pricing data: “Over the past six months, California state authorities fined more than a dozen drug makers a total of $17.5 million for failing to report price hikes as required by law, and more than half of the penalties were levied since the beginning of the year…”

About the public’s health

Leaving Off Mask At Mayo Clinic, Pence Said He Wanted To Look Workers 'In The Eye': A few things are very wrong here:
1. If the excuse for not wearing a mask was that he couldn’t look workers in the eye, then he is putting his mask on the wrong part of his head.
2. He also said he is tested regularly and so he knows he is not infected. Guess the words “role model” do not apply.
3. The Mayo Clinic informed him before his visit of their masking policy. I wonder when he visits foreign countries as a US representative if he ignores their local customs.

Quest Diagnostics rolls out direct-to-consumer coronavirus antibody tests: Quest will screen “patients online to determine whether or not an antibody test is appropriate and then sends them to have their blood drawn at one of the company’s 2,200 laboratories…The test costs $119, according to Quest’s website.” Since no physician order is needed, it is unclear if insurance will pick up the cost.  

Wolters Kluwer Launches MediRegs COVID-19 Regulatory Search for Federal and State Regulations: “ Wolters Kluwer Legal & Regulatory U.S. today launched the MediRegs COVID-19 Regulatory Search, the first free resource of its kind that offers quick access to state and federal regulations related to the pandemic. The digital resource is available on the open web to support coding, reimbursement and compliance professionals.”

Profile of RT-PCR for SARS-CoV-2: a preliminary study from 56 COVID-19 patients:In 56 patients with mild to moderate disease (none required ICU care), the majority tested positive for SARS-CoV-2 “within 3 weeks after the onset of symptoms.” The negative results started substantially to decline “from week 4 after onset of symptoms and by the end of follow-up (6 weeks), all results of RT-PCR test were negative… According to the results in our study, we suggested prolonged observation and repeat confirmation of RT-PCR test from respiratory specimens for safe discharges and discontinuation of quarantine.”

Aerodynamic analysis of SARS-CoV-2 in two Wuhan hospitals:“The concentration of SARS-CoV-2 RNA in aerosols detected in isolation wards and ventilated patient rooms was very low, but it was elevated in the patients’ toilet areas. Levels of airborne SARS-CoV-2 RNA in the majority of public areas was undetectable except in two areas prone to crowding, possibly due to infected carriers in the crowd…Although we have not established the infectivity of the virus detected in these hospital areas, we propose that SARS-CoV-2 may have the potential to be transmitted via aerosols. Our results indicate that room ventilation, open space, sanitization of protective apparel, and proper use and disinfection of toilet areas can effectively limit the concentration of SARS-CoV-2 RNA in aerosols. Future work should explore the infectivity of aerosolized virus.”

About healthcare systems

Advocate Aurora offers bonuses to more than 60,000 workers: While many systems are cutting pay, even for those in the “front lines,” this system is honoring its bonus system by “providing $15 million in award payments to more than 60,000 eligible employees in recognition of their work during 2019.”

About health insurance

COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing and Treatment of the Uninsured: Here is the website providers can consult for reimbursement for COVID-19 treatment delivered to uninsured patients.

CMS Announcement May Create More Medicare Advantage Opportunities for Home Care Providers: CMS announced that Medicare Advantage plans can enhance benefits mid-year to accommodate problems caused by COVID-19. Usually the benefits need to be locked-in at the beginning of the contract year.

Health insurers prosper as COVID-19 deflates demand for elective treatments: “…credit rating agency Moody’s… looked at a range of pandemic scenarios—from mild to severe—and concluded that ‘U.S. health insurers will nonetheless remain profitable under the most likely scenarios.’”

Assessment of Completeness of Hospital Readmission Rates Reported in Medicare Advantage Contracts’ Healthcare Effectiveness Data and Information Set [HEDIS]: “…the readmission rates of underreported admissions were approximately 2 times greater than the readmission rates of those included in HEDIS data. The proportion of underreported index admissions in HEDIS varied widely across MA contracts. Medicare Advantage contracts with the most complete reporting were penalized in rankings compared with contracts with less-complete HEDIS data [emphasis added]…Because HEDIS performance affects star ratings, bonus payments, and patients’ plan choices, CMS should consider rigorous audits of HEDIS data, particularly their denominators.”

Today's News and Commentary

About the public’s health

'No Evidence' Yet That Recovered COVID-19 Patients Are Immune, WHO Says: “In a scientific brief dated Friday, the United Nations agency said the idea that one-time infection can lead to immunity remains unproven and is thus unreliable as a foundation for the next phase of the world's response to the pandemic.”

FDA warns 10 firms against sale of products promoting teen vaping: “The U.S. Food and Drug Administration (FDA) on Monday warned 10 manufacturers and retailers against selling or producing products likely to promote e-cigarette use among teenagers.”

U.S. deaths soared in early weeks of pandemic, far exceeding number attributed to Covid-19: ”The excess deaths are not necessarily attributable directly to Covid-19, the disease caused by the coronavirus. They could include people who died because of the epidemic but not from the disease, such as those who were afraid to seek medical treatment for unrelated illnesses, as well as some number of deaths that are part of the ordinary variation in the death rate. The count is also affected by increases or decreases in other categories of deaths, such as suicides, homicides and motor vehicle accidents.”

U.S. states build stockpiles of malaria drug touted by Trump: “At least 22 states and Washington, D.C., secured shipments of the drug, hydroxychloroquine, according to information compiled from state and federal officials by The Associated Press. Sixteen of those states were won by Trump in 2016, although five of them, including North Carolina and Louisiana, are now led by Democratic governors.” Oklahoma alone spent $2 million. I suppose if there is that much money to waste on ineffective treatments that there is plenty to help people get good health care.

About health insurance

HHS files appeal to reinstate controversial MA overpayment rule: “The Department of Health and Human Services (HHS) has filed an appeal to reinstate a key rule that handles overpayments to Medicare Advantage (MA) plans, arguing a lower court's ruling was based on a flawed premise.
The appeal…could decide how much money MA plans, an increasingly lucrative market for insurers, will have to give back to Medicare for diagnosis errors.” Recall MA plans’ payments depend on the diagnoses.

About hospitals

Amid coronavirus distress, wealthy hospitals hoard millions: This article is a nice review of the disparities in hospital financial viability.

Today's News and Commentary

About pharma

Gilead sues US, claims it illegally acquired Truvada patents:Gilead Sciences has filed a lawsuit accusing the CDC of breaching several contracts to obtain patents for the intellectual property behind the drugmaker's Truvada HIV-prevention drug…
In the suit, filed April 24, Gilead claims the CDC violated the terms of a 15-year-old collaboration between the two parties by failing to tell Gilead that it would obtain patents on the research that led to the development of Truvada.”

About health insurance

Supreme Court rules government must pay billions to Obamacare insurers: In the early years of the ACA, the federal government had a “risk corridor” program to cap both profits and losses. The financial underpinnings, however depended on more profitable plans subsidizing those with losses. Since, overall, the program sustained more losses than gains, the federal government argued it did not owe money to the insurance companies.So the insurers sued. In the meantime, some smaller startups who needed the subsidies went out of business.
In an 8-1 vote today, the Supreme Court decided the government does owe the money.

Expansion of the Accelerated and Advance Payments Program for Providers and Suppliers During COVID-19 Emergency: “Beginning on April 26, 2020 CMS will not be accepting any new applications for the Advance Payment Program, and CMS will be reevaluating all pending and new applications for Accelerated Payments in light of historical direct payments made available through HHS’s Provider Relief Fund. Significant additional funding will continue to be available to hospitals and other healthcare providers through other programs.” This announcement is a huge change for the way CMS pays providers and it may be a while before it is reversed.

A Dozen Facts About Medicare Advantage in 2020: This article is a really good summary of the status of the MA program. “In 2020, more than one-third (36%) of all Medicare beneficiaries – 24.1 million people out of 67.7 million Medicare beneficiaries overall – are enrolled in Medicare Advantage plans; this rate has steadily increased over time since the early 2000s.”

About the public’s health

Symptoms of Coronavirus: The CDC just updated its list of symptoms and signs of COVID-19:

• Fever

• Cough

• Shortness of breath or difficulty breathing

• Chills

• Repeated shaking with chills

• Muscle pain

• Headache

• Sore throat

• New loss of taste or smell

FDA greenlights two blood-filtering systems for COVID-19:”The FDA granted two emergency authorizations to blood-filtering devices designed to assist the distressed immune and respiratory systems of patients with severe cases of COVID-19.”

Trump team moves to scrap protections for LGBTQ patients:”The Trump administration is moving to scrap an Obama-era policy that protected LGBTQ patients from discrimination, alarming health experts who warn that the regulatory rollback could harm vulnerable people during a pandemic.”
HHS is “close to finalizing its long-developing rewrite of Obamacare’s Section 1557 provision, which barred health care discrimination based on sex and gender identity.” 

Total and High-density Lipoprotein Cholesterol in Adults: United States, 2015–2018: Finally, some good news: “High total cholesterol prevalence declined from 1999–2000 to 2017–2018. Low HDL-C prevalence declined from 2007–2008 to 2017–2018.” The prevalence of high cholesterol in the total population declined about 8% in that time.

Ninety-seven million Vietnamese people escape death from Coronavirus: While these data are “unaudited,” if true they provide insight into what can be done with an aggressive, early response to a pandemic.

Coffee consumption and mortality from cardiovascular diseases and total mortality: Does the brewing method matter?: Bottom line: “Unfiltered brew [such as espresso, boiled coffees and coffee made with a French press] is associated with higher mortality than filtered brew, and filtered brew was associated with lower mortality than no coffee consumption.”

About healthcare IT

IBM Rapid Supplier Connect: Emergency supplier onboarding and inventory availability: “IBM Rapid Supplier Connect makes it possible for buyers and suppliers – including non-traditional suppliers joining the fight to help keep hospitals and key support organizations ready – to quickly find each other, accelerate verification and onboarding processes, and gain near real-time insights into inventories of life-saving equipment. It combines a scalable blockchain for business network, proven supply chain solutions, and a network of dedicated industry and technical experts.”

And just interesting

Billionaire Bonanza 2020: Wealth Windfalls, Tumbling Taxes, and Pandemic Profiteers: “Between March 18 and April 10, as the U.S. employment rate approached 15 percent, the combined wealth of America’s billionaires increased by $282 billion — nearly a 10 percent increase. After a brief decline, the combined wealth of U.S. billionaires is greater than their 2019 levels.”

Today's News and Commentary

About the public’s health

Trump suggests 'injection' of disinfectant to beat coronavirus and 'clean' the lungs: Undoubtedly you have heard or heard about this statement. The White House claims it was taken out of context. Here is the video clip of what he said- you decide. By the way, I asked my 6 year old grandson what he thought about taking disinfectant to wipe out the corona virus. His response: “[Visual wince] It’s poisonous!”

What Impact Has COVID-19 Had on Outpatient Visits?: Bottom line: “The number of visits to ambulatory practices declined nearly 60 percent in mid-March and has remained low through mid-April.”

No need to wipe down groceries or takeout, experts say, but do wash your hands: The headline has the message but there is good documentation on the article.

About health insurance

From CMS: Information Related to Coronavirus Disease 2019 - COVID-19: Many requirements for quality and payment reporting are being relaxed during the COVID-19 pandemic. This latest summary also includes the recommendation that Medicare Advantage plans relax prior authorizations.

About pharma

Did Gilead's remdesivir flop a Chinese trial? Analysts beg to differ: The World Health Organization (WHO) "accidentally revealed data from a study in China” showing that Gilead Sciences' remdesivir treatment “neither improved patients’ condition nor tamped down on the amount of virus in their blood…” However, the conclusion is not that clear and the quick look at the data might be easily misinterpreted. This article is a good analysis of how findings are analyzed and a good lesson to do your own evaluation.

Today's News and Commentary

About the public’s health

How coronavirus spreads through a population and how we can beat it: This excellent article with interactive graphics explains how a pandemic can spread given infectivity, contact rates and mortality. Even if you are a public health professional, it is worth a read.

Two major stories today chronicle Health and Human Services Secretary Alex Azar’s role in the COVID-19 pandemic. The first is from The Wall Street Journal’s front page: Health Chief’s Early Missteps Set Back Coronavirus Response. The other is from Reuters: Special Report: Former Labradoodle breeder was tapped to lead U.S. pandemic task force. The reference is to Azar’s former chief of staff, Brian Harrison, whom Azar recruited to run the HHS pandemic task force before VP Pence took over. Harrison previously ran a dog-breeding business for six years.

‘Where are all our patients?’: Covid phobia is keeping people with serious heart symptoms away from ERs: “A survey of nine major hospitals earlier this month showed the number of severe heart attacks being treated in U.S hospitals had dropped by nearly 40% since the novel coronavirus took hold in March, leaving cardiologists worried about a second wave of deaths caused indirectly by Covid-19: patients so afraid to enter hospitals that they are dying at home or waiting so long to seek care that they’re going to suffer massive damage to their hearts or brains. Some call it ‘a virus of fear.’”

KFF Health Tracking Poll - Late April 2020: Coronavirus, Social Distancing, and Contact Tracing: “The latest KFF Health Tracking Poll conducted April 15-20th finds about half the public (51%) now saying that when it comes to the coronavirus outbreak in the U.S., “the worst is yet to come.” This is down 23 percentage points from the share who said the same (74%) in the… poll conducted less than three weeks ago. Majorities of Democrats (64%) and independents (56%) continue to say ‘the worst is yet to come,’ but now twice as many Republicans say ‘the worst is behind us’ (53%) as say ‘the worst is yet to come’ (27%).
While an increasing share of the public now say the worst of the outbreak is behind us, most Americans (80%) say strict shelter-in-place measures are worth it…”

Tiny Drugmaker Joins 3M, J&J in $7.2 Billion U.S. Virus Windfall: Here are the top 20 companies contracted by the federal government to combat COVID-19. Most contracts are for ventilators, masks and vaccines (presumably development).

The race to develop a COVID-19 vaccine: 5 updates: A good summary of where we are on this development.

Two cats in New York are first pets known to have coronavirus in the US: “Two cats in New York have been infected with the novel coronavirus, federal officials announced Wednesday. Both had mild respiratory symptoms and are expected to make a full recovery.
’These are the first pets in the United States to test positive,’ the US Department of Agriculture said Wednesday in a joint statement with the US Centers for Disease Control and Prevention.
The agencies emphasized that there is no evidence pets play a role in spreading coronavirus in the United States. ‘There is no justification in taking measures against companion animals that may compromise their welfare,’ they said.”

California OKs resumption of elective procedures: “California hospitals will be allowed to resume nonemergency surgeries and procedures, including removing tumors, heart valve replacements and key preventive care services like colonoscopies. Purely cosmetic procedures are still banned.” Other states are also slowly rolling back restrictions for procedures on which hospitals are economically dependent.

Adding A Nylon Stocking Layer Could Boost Protection From Cloth Masks, Study Finds: The study has not been peer-reviewed but the recommendation makes sense.

Court allows Arkansas ban on surgical abortions due to virus: “A three-judge panel of the 8th U.S. Circuit Court of Appeals dissolved a judge’s temporary restraining order that allowed surgical abortions to continue after the Arkansas Department of Health told the state’s only surgical abortion clinic to stop performing the procedure unless it was needed to protect the life or health of the mother.”

The Post-Pandemic Style: An interesting article on how architectural changes occurred to address public health issues.

About health insurance

2020 Annual Report of the Boards of Trustees of the Federal Hospital Insurance [Medicare Part A] and Federal Supplementary Insurance [Medicare Part B] Trust Funds: Start on page 6 of the document for a summary. In short: “In 2019, HI expenditures exceeded income by $5.8 billion. The Trustees project deficits in all future years until the trust fund becomes depleted in 2026….The HI trust fund does not meet either the Trustees’ test of short-range financial adequacy or their test of long-range close actuarial balance.” The Medicare effect of COVID-19 infections is yet to be determined but will be a balance of the increased cost for acute care in the short run versus the reduced long term costs due to deaths.

Some providers facing issues getting paid for telehealth visits: The article is a good summary (with examples) of the problem in the headline.

However…

Coronavirus Fuels Explosive Growth In Telehealth ― And Concern About Fraud: This article explains the “other side” of facilitating telehealth payments.

Administration offers plan to cover COVID care for uninsured: “Under the approach detailed by Health and Human Services Secretary Alex Azar, hospitals and doctors would submit their bills directly to the government and they would get paid at Medicare rates.
Uninsured people would not be liable for costs, and health care providers would not have to ask any questions about a patient’s immigration status, an issue that’s been cited as a barrier to care in communities with many foreign-born residents.
‘This says if you don’t have insurance, go get taken care of — we have you covered,’ Azar said in an interview.”

About healthcare quality

CMS Suspends Quality Reporting Measures Amid Pandemic: The suspended measures are the Qualified Health Plan Enrollee Survey, Quality Improvement Strategy, and Quality Rating System for plan year 2021.

Consumer Perspectives on Patient Experience in the U.S.: “Despite lower engagement in healthcare activities and the spread of COVID-19, consumers are more positive about overall healthcare quality (+13%) and their own care experiences (+7%) compared to January. 
Cost remains the most important healthcare issue for consumers. The top 3 issues include affordable health insurance coverage, out-of-pocket costs, and the cost of health insurance premiums.”

About healthcare personnel

International Docs Held Back From COVID Front Lines: The article explains the precarious situation of International Medical Graduates, who are essential to meeting our country’s healthcare needs (even before the COVID-19 pandemic).

Today's News and Commentary

Happy Earth Day!

50 Years of Earth Day: What’s Better Today, and What’s Worse: Good summary from The New York Times of the status of the environment.

What's the State of YOUR Air?: This interactive site from the American Lung Association allows you to check the quality of your local air.

About healthcare IT

Healthcare Interoperability Expanded Significantly in 2019 with More than 19 Billion Secure Health Data Transactions Nationwide: “Healthcare interoperability and enhanced information sharing continued to improve healthcare quality, safety and cost for U.S. patients and providers, according to the Surescripts 2019 National Progress Report. The nationwide health information network processed 19.15 billion secure transactions in 2019, while connecting 1.78 million healthcare professionals and organizations with actionable patient data for 95% of the U.S. population.” See the report for more details.

CMS Interoperability and Patient Access final rule: “CMS is extending the implementation timeline for the admission, discharge, and transfer (ADT) notification Conditions of Participation (CoPs) by an additional six months. In the version of the rule displayed on March 9, 2020 on the CMS website, it stated these CoPs would be effective 6 months after the publication of the final rule in the Federal Register. We have changed this in the final rule now displayed on the Federal Register to state that the new CoPs at 42 CFR Parts 482 and 485 will now be effective 12 months after the final rule is published in the Federal Register.”

Nearly 25,000 email addresses and passwords allegedly from NIH, WHO, Gates Foundation and others are dumped online: The SITE Intelligence Group, which monitors online extremism and terrorist groups…"was unable to verify whether the email addresses and passwords were authentic…” The information was released Sunday and Monday and “almost immediately used to foment attempts at hacking and harassment by far-right extremists. An Australian cybersecurity expert, Robert Potter, said he was able to verify that the WHO email addresses and passwords were real.”

About the public’s health

CDC director warns second wave of coronavirus is likely to be even more devastating: “…the director of the Centers for Disease Control and Prevention warned Tuesday that a second wave of the novel coronavirus will be far more dire because it is likely to coincide with the start of flu season.” But COVID-19 hit in flu season this year. Perhaps more people will get flu shots next time around. This year we were also lucky that the flu strains were sensitive to the usual anti-viral drugs.

Guidance for Licensed Independent Freestanding Emergency Departments (EDs) to Participate in Medicare and Medicaid during the COVID-19 Public Health Emergency: “CMS is creating additional flexibilities to allow licensed independent freestanding emergency departments (EDs) to participate in Medicare and Medicaid to help address the urgent need to increase hospital capacity to provide care to patients…
Due to their existing infrastructure, independent freestanding EDs, which have no hospital affiliation and are specifically licensed by the state to operate independently to provide emergency services, have been identified as a critical resource to assist in expanding capacity for inpatient and outpatient hospital services for patients requiring a higher level of care. Currently, only four states license independent freestanding EDs to operate without hospital affiliation Colorado, Delaware, Rhode Island, and Texas.”

Immediate Use Steam Sterilization (IUSS) Sterilizes N95 Masks Without Mask Damage: In addition to hydrogen peroxide and UV light treatments: “Despite the limitations of this study, the data herein provide a valid basis for the use of IUSS [Immediate-use steam sterilization] N95 masks to prevent the spread of COVID-19 to healthcare workers.”

About pharma

Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19: Here is the original pre-publication paper that was widely referenced in today’s media. “In this study, we found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with Covid-19. An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone. These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs.” The death rate in the hydroxychloroquine [HC] group was 27.8%, compared to 11.4% in the no- HC group.

Glaucoma could be successfully treated with gene therapy : “A new study led by the University of Bristol has shown a common eye condition, glaucoma, could be successfully treated with a single injection using gene therapy, which would improve treatment options, effectiveness and quality of life for many patients.”

DOJ Won’t Challenge AmerisourceBergen’s COVID-19 Efforts: “The DOJ decided earlier this month to waive antitrust concerns about collaborative efforts by McKesson and Cardinal Health to distribute medical supplies during the pandemic.”

About hospitals

How COVID-19 Could Inform the Future of Hospital Design: Fascinating discussion of creative and flexible hospital designs from Smithsonian Magazine.

5th Circuit upholds CMS rule tweaking DSH payment calculations: “A federal appeals court has upheld a rule that would allow the Centers for Medicare & Medicaid Services (CMS) to include payments from Medicare and private payers in calculating disproportionate share hospital (DSH) payment caps. 
The opinion (PDF), issued Monday, reversed a lower court win for eight Mississippi hospitals challenging the payment changes. The 5th Circuit Court argues that wording in the Medicaid Act on how the payments must be calculated is ambiguous, giving the Department of Health and Human Services (HHS) room to interpret it. “

About healthcare personnel

Emergency room doctors facing pay cuts and understaffing during pandemic: “CBS News spoke with ER doctors in at least half a dozen states who said they're taking pay cuts of up to 40%.
The American College of Emergency Physicians said cutting benefits and shifts could force some emergency rooms to shut down.”
The physicians who are busiest and taking the highest risk are getting pay cuts? I would think they would be getting “combat pay” as a way to thank them.

Today's News and Commentary

About the public’s health

F.D.A. Approves First In-Home Test for Coronavirus: “The Food and Drug Administration on Tuesday said it had granted emergency approval to the first in-home test for Covid-19, a nasal swab kit that will be sold by LabCorp… Patients will swab their own nose using a testing kit sent by the company, and will mail it in an insulated package back to the company. The test, called the Pixel, will be available to consumers in most states, with a doctor’s order, the agency said.”

Study Raises Questions About False Negatives From Quick COVID-19 Test: A related article discusses how the sensitivities of some of the commonly used tests can greatly vary. READ THIS ONE!

US lockdowns coincide with rise in poisonings from cleaners: “Reports of accidental poisonings from cleaners and disinfectants are up this year, and researchers believe it’s related to the coronavirus epidemic.”

Los Angeles coronavirus infections 40 times greater than known cases, antibody tests suggest:”Some 4.1% of adults tested positive for coronavirus antibodies in a study of Los Angeles County residents, health officials said on Monday, suggesting the rate of infection may be 40 times higher than the number of confirmed cases.” Read this article, not as an LA story, but how prevalence in the U.S. may be much greater than is documented.

Reports suggest many have had coronavirus with no symptoms: In a related article to the one above, this one delves into more details.

Association Between Breastfeeding and Ovarian Cancer Risk:”Breastfeeding is associated with a significant decrease in risk of ovarian cancer overall and for the high-grade serous subtype, the most lethal type of ovarian cancer. The findings suggest that breastfeeding is a potentially modifiable factor that may lower risk of ovarian cancer independent of pregnancy alone.” Longer breast feeding yields greater benefits, e.g., “breastfeeding for 12 or more months was associated with a 34% lower risk.” 

About health insurance

Moody's: Payers likely to weather the COVID-19 financial storm: “ The analysts said that even in the most severe scenario modeled, where 40% of Americans are infected by the virus, companies would likely break even on EBITDA and have notable capital and liquidity. “

CMS to pay providers via MIPS for participating in COVID-19 drug treatment trials:”Clinicians can earn a credit via the Merit-based Incentive Payment System (MIPS) if they participate in a clinical trial and report clinical information on COVID-19, the Trump administration announced late Monday….To receive the credit, clinicians must attest to CMS they are participating in a clinical trial on a COVID-19 drug or biologic to treat patients. The clinicians have to report their findings via a clinical data repository or data registry for the duration of the study, the agency adds.” With reduced volumes, clinicians need other means to preserve their payments and avoid penalties beyond their control.

About healthcare IT

Google opens Cloud Healthcare API to health systems to support data exchange: “Google is making its Cloud Healthcare API (application programming interface) available to the industry at large. The tool facilitates the exchange of data between healthcare applications and solutions built on Google Cloud and enables a unified view of patient data…The Cloud Healthcare API supports popular healthcare data standards such as HL7 FHIR (Fast Healthcare Interoperability Resources), HL7 v2 and DICOM.”

Covid-19: remote consultations: This excellent graphic from BMJ is ”intended for use in a primary care setting…”

About healthcare personnel

Trump says he will suspend immigration, but provides few details about the plan: The status of healthcare workers is unknown- particularly international medical graduates who need visas to start their training.

About pharma

Amid Pandemic, FDA Seizes Cheaper Drugs From Canada: “The Food and Drug Administration in the past month has stepped up seizures of prescription drugs being sent to American customers from pharmacies in Canada and other countries, according to operators of stores in Florida that facilitate the transactions…
The latest seizures come as the Trump administration works with Florida, Colorado and other states to set up a system to help more Americans import drugs from Canada, where many brand-name medications are significantly cheaper than in the United States.
About 2% of American adults say they buy drugs from outside the United States — either over the internet or during travels to Canada or overseas.”

Today's News and Commentary

About the public’s health

Influential Covid-19 model uses flawed methods and shouldn’t guide U.S. policies, critics say: The University of Washington predictions for COVID-19 spread have been used by policy makers for addressing the epidemiology of this disease. This article is an excellent summary of the critiques of the model.

No proof of immunity in recovered coronavirus patients, says WHO: “Speaking at a press conference in Geneva, Dr Maria van Kerchief said: ‘There are a lot of countries that are suggesting using rapid diagnostic serological tests to be able to capture what they think will be a measure of immunity. Right now, we have no evidence the use of a serological test can show that an individual has immunity or is protected from reinfection.’”

Twelve takeaways from the 1918 flu epidemic that help us think about the novel coronavirus: This interview with the author of “The Great Influenza,” John M. Barry provides useful historical insights into our current pandemic. I enjoyed reading the book several years ago; it is worth your time to gain its insights.

FDA, CDC, NIH to begin validating COVID-19 antibody tests as more enter the market: “The FDA will work with the Centers for Disease Control and Prevention as well as the infectious disease and cancer research arms of the National Institutes of Health (NIH) to help generate validation data and make sure blood tests are finely tuned to detect the specific antibodies for the novel coronavirus and not for other pathogens, which may cause false positive results.”

About healthcare IT

CDC to launch clinical reporting app for COVID-19 in May: “For providers that don't have EHRs with the ability to electronically send case reports, CDC is creating a FHIR-based app to connect COVID-19 electronic case reporting (eCR) to existing health IT infrastructure to confirm cases and route the data to appropriate end users. The goal is to give public health officials a more accurate, timely picture of the pandemic.”

About healthcare finance

Private equity pushes into healthcare: 11 latest deals: Investments continue despite COVID-19. The article explains 11 private equity deals announced since March 1.

About pharma

Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency: Because of past contamination problems at compounding pharmacies, the FDA recently enhanced (and in some cases began) regulation of those facilities. In the face of potential drug shortages, the FDA is “temporarily” relaxing regulation.

16 recent drug, device recalls: “16 reported to the FDA in the last two months.”

Lilly's half-price, generic insulins now available: “‘Authorized generic’ versions of two of Eli Lilly's most popular insulins are now available for order by U.S. pharmacies, with list prices 50% lower than the companys branded versions, according to an industry press release.”

With Federal Nod, Consumers Could Lose The Boost They Get From Drug ‘Coupons’: The federal government is allowing Exchange plans to exclude the value of drug coupons when calculating deductibles and out of pocket limits- thus shifting some costs to members.

About health insurance

2020 Medical Loss Ratio Rebates: From the Kaiser Family Foundation: “Using preliminary data reported by insurers to state regulators and compiled by Market Farrah Associates, we estimate insurers will be issuing a total of about $2.7 billion across all markets – nearly doubling the previous record high of $1.4 billion last year. The amount varies by market, with insurers reporting about $2 billion in the individual market, $348 million in the small group market, and $341 million in the large group market. These amounts are preliminary estimates, and final rebate data will be available later this year.” The article has historical graphs of the MLR as well. The actual MLR will largely depend on the increased costs of treating COVID-19 offset by reductions in costs from elective procedures.

In Fine Print, HHS Appears To Ban All Surprise Billing During The Pandemic: “Federal officials offering emergency funding to hospitals, clinics and doctors’ practices have included this stipulation: They cannot foist surprise medical bills on COVID-19 patients.
But buried in the Department of Health and Human Services’ terms and conditions for eligibility is language that could carry much broader implications. It says ‘HHS broadly views every patient as a possible case of COVID-19,’ the guidance states.” We will need to see how this provision plays out, but could be a significant step to remove surprise billing.

Today's News and Commentary

About the public’s health

G7 backing for WHO leaves Trump isolated at virtual summit: “Donald Trump found himself isolated among western leaders at a virtual G7 summit, as they expressed strong support for the World Health Organization after the US’s suspension of its funding.” For another view that discusses the WHO’s warnings, see: W.H.O., Now Trump’s Scapegoat, Warned About Coronavirus Early and Often, the headline speaks for itself.

Docs could face looming health crisis as COVID-19 disrupts care for chronically ill: “…69% of chronic disease patients reported some degree of impact on their ability to manage one of seven high-risk conditions. Those conditions include diabetes, high blood pressure, migraine, asthma, cancer, multiple sclerosis and autoimmune illnesses such as rheumatoid arthritis.
Patients voiced concerns about access to care during the health crisis and worried about how to pay for their medications after being furloughed or laid off.”

Joint Statement: Roadmap for Resuming Elective Surgery after COVID-19 Pandemic: The criteria were developed by the: American College of Surgeons, American Society of Anesthesiologists, Association of periOperative [sic] Registered Nurses and American Hospital Association. This site provides a download link to a monograph. It is a well-considered, clear outline for when elective surgery should resume and how it should be re-instituted.

Most Americans Say Trump Was Too Slow in Initial Response to Coronavirus Threat: More important than the political part of this Pew Research Center poll is that: “73% of U.S. adults say that in thinking about the problems the country is facing from the coronavirus outbreak, the worst is still to come…
About twice as many Americans say their greater concern is that state governments will lift restrictions on public activity too quickly (66%) as say it will not happen quickly enough (32%).” Perhaps this strong public sentiment will hold down the infection’s spread. But opinions were divided along political party lines.

China says nearly 1,300 virus deaths not counted in Wuhan, cites early lapses: “Nearly 1,300 people who died of the coronavirus in the Chinese city of Wuhan, or half the total, were not counted in death tolls because of lapses, state media said on Friday, but Beijing dismissed claims that there had been any kind of cover-up.”

Clinical prediction models were appraised for detecting risk for admission for COVID-19 pneumonia; diagnosis in suspected COVID-19 infection; and prognosis in patients with a COVID-19 diagnosis: “This review indicates that proposed models are poorly reported, at high risk of bias, and their reported performance is probably optimistic.” In other words, we need more and better research on this topic.

About healthcare personnel

State of the World’s Nursing- 2020: The World Health Organization (WHO) has designated 2020 as the “Year of the Nurse and Midwife,” in honor of the 200th birth anniversary of Florence Nightingale. This site provides a link to an excellent monograph on this subject.

About diagnostics

Proteomics International Earns CE Mark for Kidney Disease Test: “The blood test assesses the risk of diabetic kidney disease in type 2 diabetes patients using a unique protein fingerprint that can signal onset of the disease up to four years ahead of symptoms.” Could be of real help in anticipatory treatment.

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About health insurance

CMS boosts Medicare payments for high-throughput COVID-19 diagnostic tests: “The agency said Medicare will pay a higher payment of $100 for COVID-19’s clinical diagnostic lab tests that use ‘high-throughput technologies developed by the private sector that allow for increased testing capacity, faster results and more effective means of combating the spread of the virus.’”

UnitedHealth Reports Profit, Citing Falling Demand for Elective Care: Despite lower enrollment (see yesterday’s blog), “UnitedHealth reported earnings from operations increased by 3 percent, to $5 billion, for the first quarter of 2020, compared with the same three months of 2019, on revenue of $64 billion.”
Elective procedure volume was markedly down, but so was its surgicenter volume. The Optum division also contributed to the increased revenue. Its PBM has not been hit because there is no treatment for COVID-19 and premiums continue to come in.

The telehealth services Aetna, UnitedHealthcare & more payers are covering during COVID-19 pandemic: Here is a list of where to find telehealth coverage for the major private insurers.

About the public’s health

Chest X-Ray Findings in 636 Ambulatory Patients with COVID-19 Presenting to an Urgent Care Center: A Normal Chest X-Ray Is no Guarantee: COVID-19 causes a classic “ground glass” appearance on chest x-ray. However, this research found that the X-rays “obtained from confirmed and symptomatic COVID-19 patients… were normal in 58.3% of cases, and normal or only mildly abnormal in 89% of patients.”

How Bubonic Plague Has Helped Russia Fight the Coronavirus: Russia’s 20th century experience with bubonic plague created an effective process for rapid containment and coordinated action in the face of a contagious threat.

How Many Times Can an N95 Mask Be Sanitized and Reused?:”Both ultraviolet light and vaporized hydrogen peroxide met the bar for killing off SARS-CoV-2 virus that causes COVID-19 without impacting fit testing for two rounds of wear and decontamination compared with control respirators. Filtration remained ‘acceptable’ after a third round for those two methods as well…A separate group studying N95 respirator decontamination has cautioned that soapy water, alcohol, bleach immersion, and overnight storage are unsuitable.”

Liechtenstein rolls out radical Covid-19 bracelet programme: ”The principality of Liechtenstein is piloting a programme to fit its citizens with biometric bracelets in a radical new drive to track the emergence of potential cases of Covid-19 in real time. On Thursday, one in 20 Liechtensteiners will be offered the bracelets, which will send data on vital bodily metrics including skin temperature, breathing rate and heart rate back to a Swiss laboratory for analysis.  In a second phase, which will begin in the autumn, bracelets will be offered to the whole population…”

BCG vaccine not recommended for virus: WHO : " ‘There is no evidence that the BCG vaccine protects people against infection with COVID-19 virus,’ the WHO said in response to reports that countries where the vaccine for tuberculosis (TB) was used have a lower incidence of coronavirus infections and deaths.”

New Data on Hydroxychloroquine Shows Little Benefit:”The malaria drug did appear to reduce inflammation, but more adverse events were observed in the hydroxychloroquine group vs. the standard-of-care cohort.”

As demand surges, half of prescriptions needed for Covid-19 patients on ventilators are going unfilled: “As the pandemic continues to spread across the U.S., orders for medicines needed for Covid-19 patients who are placed on ventilators are being filled and shipped to hospitals only 53% of the time, down from 72% last month, according to new data.
The decline reflects surging demand for more than a dozen sedatives, anesthetics, painkillers, and muscle relaxants, which have been in short supply. The findings raise the possibility that it could become more difficult for health care providers to place these patients on ventilators, because the drugs are used to help manage pain and comfort levels while a patient is on mechanical ventilation.”

Coronavirus destroys lungs. But doctors are finding its damage in kidneys, hearts and elsewhere.: The primary manifestation of COVID-19 may not only be respiratory. ”…clinicians around the world are seeing evidence that suggests the virus also may be causing heart inflammation, acute kidney disease, neurological malfunction, blood clots, intestinal damage and liver problems.”

CMS loosens clinician scope-of-practice, telehealth rules for COVID-19 crisis:”To boost the capacity of frontline clinicians and facilities to fight COVID-19, the Centers for Medicare & Medicaid Services (CMS) on Thursday announced it is temporarily suspending rules to allow physicians to provide telehealth services across state lines, and will permit midlevel practitioners to provide as much care as their state licenses allow.”

China didn’t warn public of likely pandemic for 6 key days: “In the six days [Jan. 14 to Jan. 20] top Chinese officials secretly determined they likely were facing a pandemic from a new coronavirus, the city of Wuhan at the epicenter of the disease hosted a mass banquet for tens of thousands of people; millions began traveling through for Lunar New Year celebrations.
President Xi Jinping warned the public on the seventh day, Jan. 20. But by that time, more than 3,000 people had been infected during almost a week of public silence, according to internal documents obtained by The Associated Press and expert estimates…”

The lessons we didn’t learn from Ebola:”An interview with Christopher Kirchhoff, who wrote a post-mortem of the US Ebola response for the National Security Council:

…Ebola taught us that there’s an incredible penalty for inaction, because epidemics grow exponentially: every day you delay responding, you end up facing a steeper exponential curve that makes the situation quickly transition from what would have been manageable to something that’s unmanageable. This is where we are today. You have to imagine that the presence of an office well staffed with professionals in emerging infectious diseases would have been able to help the US government be more nimble in those crucial early days, when more capabilities could have been brought online and could have been ready to help us get ahead of the curve.” More details are in the interview.

Today's News and Commentary

About pharma

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

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

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

About the public’s health

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

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

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

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

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

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

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

About health insurance

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

Today's News and Commentary

About health insurance

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

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

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

About pharma

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

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

About the public’s health

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

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

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

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

About emerging science

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

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About health insurance

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

• These laws apply to all payers including ERISA plans

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

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

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

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

About the public’s health

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

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

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

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

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

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

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

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

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

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

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

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

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

About hospitals

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

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

About health insurance

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

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

About healthcare personnel

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

About pharma

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

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

Today's News and Commentary

About the public’s health

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

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

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

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

About health insurance

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

About healthcare IT

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

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

 About pharma

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

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

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

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

About health insurance

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

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

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

About pharma

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

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

About healthcare IT

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

Today's News and Commentary

World Health Day!

About the public’s health

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

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

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

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

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

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

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

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

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

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

About healthcare IT

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

About health insurance

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

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

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

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

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

About hospitals

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

Today's News and Commentary

About healthcare IT

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

About health insurance

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

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

About the public’s health

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

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

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

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

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

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

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

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

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

Today's News and Commentary

About the public’s health

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

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

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

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

About healthcare personnel

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

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

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

About healthcare IT

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

About health insurance

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

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

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

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

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

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

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

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

About pharma

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

Today's News and Commentary

About health insurance

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

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

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

About pharma

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

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

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

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

About the public’s health

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

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

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

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

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

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

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

About healthcare IT

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

About hospitals

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