Today's News and Commentary

About the public’s health

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

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

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

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

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

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

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

About pharma

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

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

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

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

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

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

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

About pharma

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

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

About healthcare IT

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

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

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

About emerging science

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

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

About health insurance

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

About hospitals

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

About healthcare professionals

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

About health insurance

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

About healthcare IT

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

About pharma

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

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

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

About healthcare professionals

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

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

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

About health insurance

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

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

About pharma

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

About hospitals

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

About health insurance

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

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

About health insurance

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

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

About pharma

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

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

About healthcare technology

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

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

About hospitals

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

About pharma

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

Today's News and Commentary

About the public’s health

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

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

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

About healthcare IT

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

About health insurance

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

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

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

Today's News and Commentary

About pharma

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

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

About the public’s health

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

About health insurance

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

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

About pharma

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

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

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

About health insurance

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

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

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

Toady's News and Commentary

About pharma

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

About hospitals

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

About the public’s health

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

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

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

About health insurance

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

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

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

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

About health insurance

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

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

About pharma

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

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

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

About hospitals

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

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

About healthcare IT

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

Today's News and Commentary

About the public’s health

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

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

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

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

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

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

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

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

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

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

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

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

About healthcare quality and safety

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

About health insurance

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

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

About healthcare IT

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

Today's News and Commentary

About the public’s health

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

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

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

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

About pharma

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

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

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 visitsThe 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.