Will Humble Disease Control, Wills Blog

Lots of Rapid Antigen Tests on the Way

Last week the federal government notified states of a plan to distribute Abbott BinaxNOW antigen rapid test kits. Arizona’s allocation is about 2 million. They’re promoted as “point of care” rapid test kits. The kit works by testing a sample collected in the nose and placed into the kit. The test can identify the antigen (unique proteins) on the coat of the SARS CoV2 virus in about 15-20 minutes.

Facilities that have a CLIA certificate of waiver can implement the test, though they do not need to be CLIA-certified laboratories. There are a couple of different routes on how this can be achieved, including applying for a waiver or being associated with a CLIA-certified or waived lab.

School nurses or school employees who have been trained can administer the test, but they’d need to be either associated with a CLIA lab authorized for moderate complexity or get a waiver.  CLIA waiver certificates are easy to get these days and approval lies within the ADHS Public Health Laboratory, so presumably the kits will be used in the field mostly under CLIA waivers. 

These rapid tests have a real opportunity to improve our response. Because results are available so quickly, it gives facilities immediate information that can inform decisions. For example, the tests could be used to screen visitors and staff at assisted living and skilled nursing facilities. Schools may be able to use it to screen students quickly and make decisions about whether to send kids home etc.

A welcome development indeed.

Will Humble Disease Control, Prevention, Wills Blog

National Academies of Medicine Release Vaccine Prioritization Recommendations

Among the most important policy decisions that need to be made in the coming weeks is how to prioritize the allocation of the early doses of vaccine. With the clinical trials showing promising results and manufacturers of several vaccines already in production (even though they are still only in Phase III Trials), it’s time to start planning how to distribute the likely vaccine(s).

Immunizing the U.S. population to prevent COVID will probably be the largest vaccination campaign ever undertaken.  A successful and equitable vaccination plan will require participation by county health departments, community health centers, healthcare providers of all kinds, emergency managers and private & nonprofit sector partners.

How should the early doses of vaccine be allocated? Fortunately the National Academies of Medicine assembled an all-star group of professionals to come up with a proposed prioritization plan that considers evidence, ethics and health disparities. It’s called the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus.

They released their final report this week, entitled Framework for Equitable Allocation of COVID-19 Vaccine.  In addition to sharing an updated framework for equitable allocation of a COVID-19 vaccine, the final report includes community engagement strategies, risk communication approaches, methods to promote vaccine acceptance, and global considerations.

National Academy Plan for the equitable allocation of vaccine report was commissioned by the NIH and CDC. It’s a long document, but here’s a snapshot of the recommendations Phase 1 populations include:

  • 1a: Front-line healthcare workers (including care home workers, hospitals, home health)

  • 1a: Emergency services workers

  • 1b: Older adults in crowded settings

  • 1b: Persons of all ages w/co-morbid conditions & significantly increased risk

Chapter 3, Page 20 gives an overview of priority populations in all 4 Phases along with a detailed rational for the various selections.

This is a well thought-through document that is objective and non-partisan. Hopefully the federal, state and county governments will loom to this landmark report as they develop the SARS CoV2 vaccination plans.

Will Humble Disease Control, Wills Blog

Dr. Gerald’s Weekly COVID Analysis

Here is Dr. Gerald’s most recent update on the COVID-19 outbreak. From Dr. Gerald… “While university campuses are improving, broader trends in the general community continue to slowly worsen. For what it is worth, test positivity for traditional PCR, saliva and antigen testing have converged around 4 – 6%.”  

“While it is difficult to understand the validity of the IHME metric regarding adherence to face mask recommendations, this week’s news is disappointing as Arizona ranks at the bottom of the 50 states. Overall, we are currently in a relatively good spot but complacency is becoming an ever greater concern with the worst case scenario being low adherence to mitigation efforts during peak viral respiratory season.”

Will Humble Disease Control, Wills Blog

What’s the Treatment Plan for the President?

By now, all of you know that the president has been diagnosed with COVID-19. Reports are that his symptoms were moderate to severe on Friday but have since improved. His symptoms have included cough, fever and low oxygen saturation levels (less than 94% on room air).

His treatment plan includes administering a course of treatment of remdesivir, a drug that slows the replication of of the virus. This medication has been shown to improve outcomes in some patients when administered early. A clinical trial found that the drug accelerated recovery among patients that had advanced disease. It was a randomized, controlled trial involving 1063 patients.

The study found that patients who got remdesivir recovered 31% faster than the people that got the placebo (p<0.001). The median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who got the placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059).

A few months ago the FDA issued an Emergency Use Authorization for remdesivir to treat COVID. That means doc’s can now prescribe for patients without enrolling them in a clinical trial or getting compassionate use approval.

The patient is also being treated with dexamethazone, a steroid. This medication is used in COVID patients that have low oxygen saturation on room air. It tamps down inflammation and has been shown to improve clinical outcomes in patients that have lowered blood oxygen levels. He received supplemental oxygen on Friday (2/L per minute).

The patient’s treatment team also administered monoclonal antibodies produced by Regeneron. This experimental monoclonal antibody treatment is still in clinical trials (it is an investigational new drug) and is available “for compassionate use” outside of clinical trials if approved by the FDA. The FDA issued such an approval Friday.

The Regeneron CEO has made statements suggesting that the drug is quite effective, but no data (that I could find) establishes this as the case. Here’s more about the investigational new drug process from a previous blog.

The patient’s treatment plan also includes zinc, vitamin D, an antacid called famotidine, melatonin and aspirin. None of these require a prescription and none have been proven to be effective against COVID-19. 

Statistically, a 74 year-old male in reasonably good health has a 3% chance of dying from COVID19. Patients in that range have symptoms bad enough to be hospitalized in about 10-15% of cases.

Persons with other underlying medical conditions (like obesity) are more likely to have a worse outcome.

On the other hand, these statistics include patients that were infected in the Spring and Summer of 2020 when less was known about effective treatment for the infection. Treatment for this illness has improved significantly in recent weeks and I expect outcomes to continue to improve as more is learned about effective therapies.

Will Humble Disease Control, Wills Blog

Journal Articles of the Week

Prevalence of SARS-CoV-2 antibodies in a large nationwide sample of patients on dialysis in the USA: a cross-sectional study The Lancet DOI:https://doi.org/10.1016/S0140-6736(20)32009-2

For this cross-sectional study, in partnership with a central laboratory that receives samples from approximately 1300 dialysis facilities across the USA, we tested the remainder plasma of 28 503 randomly selected adult patients receiving dialysis in July, 2020.

Seroprevalence of SARS-CoV-2 was 8·0% (95% CI 7·7–8·4) in the sample, 8·3% (8·0–8·6) when standardised to the US dialysis population, and 9·3% (8·8–9·9) when standardised to the US adult population. When standardised to the US dialysis population, seroprevalence ranged from 3·5% (3·1–3·9) in the west to 27·2% (25·9–28·5) in the northeast. (0·4 [0·3–0·5]) when compared with a reduction of less than 5%.

During the first wave of the COVID-19 pandemic, fewer than 10% of the US adult population formed antibodies against SARS-CoV-2, and fewer than 10% of those with antibodies were diagnosed. Public health efforts to limit SARS-CoV-2 spread need to especially target racial and ethnic minority and densely populated communities.

MMWR: Changing Age Distribution of the COVID-19 Pandemic

The CDC released an MMWR describing the changing age distribution of COVID-19 infections in the United States from May-August 2020. During the first months of the pandemic, COVID-19 incidence was highest among older adults, but between June-August, COVID-19 incidence was highest in persons aged 20–29 years. This report provides preliminary evidence that younger adults contributed to community transmission of COVID-19 to older adults

Will Humble Disease Control, Wills Blog

New Visitation Policies for Long Term Care

Visitation policies for long term care facilities are in the process of changing, thanks to the lower level of community spread that resulted from interventions by cities and counties to require face coverings, the several week suspension of bars and nightclubs, and the better (but not great) business and bar compliance with recommended CDC mitigation measures.

Family members or friends of folks living in assisted living or skilled nursing (and designated caregivers) will be given access to the facilities during normal pre-COVID visitation hours if they meet certain conditions, like providing a negative COVID test result within the last week. Here’s a description of the policy changes.    

Will Humble Public Health, Wills Blog

AzPHA Wins the National APHA Vision Award for Excellence in Health Policy

Below is an e-ail that we received notifying us that AzPHA will be receiving APHA’s Vision Award for Excellence in Health Policy Award this year:

Congratulations! On behalf of the APHA Community Health Planning and Policy Development (CHPPD) section of the American Public Health Association, we are honored to present you with the Vision Award for Excellence in Health Policy.

We were inspired to read about your work promoting public health policy and equity in Arizona through advocacy, research, teaching, and health communication. 

We plan to present the award at the CHPPD awards assembly at the APHA Annual Meeting, which will be virtual this year. The event will be on October 25 from 6-8 pm Mountain Time. If you are unable to attend, you are also welcome to submit a short video (5 minutes or less) describing a few key lessons you’ve learned through your experience or advice you would give to other public health professionals. Please let us know which option would be more convenient for you.

We will mail the physical award to your address. Please let us know what address you would like us to mail the award to and how you would like your name and credentials to appear on the award. We will make every effort to present the information as you would like. Could you please also send a photo that we could use to share in our social media?   

Congratulations again, and please let us know if you have any questions.

Will Humble Uncategorized, Wills Blog

FDA Authorizes First Point-of-Care Antibody Test for COVID-19

FDA issued an emergency use authorization for the first antibody point-of-care test for COVID-19. The “Assure COVID-19 IgG/IgM Rapid Test Device” was given emergency use authorization in July to help identify individuals with antibodies to SARS-CoV-2. The EUA was reissued this week authorizing the test using the fingerstick method.  The press release is here.

Rapid antibody tests that also include a specific test for IgM antibodies can sometimes be useful to identify newly infected people. That’s because the very first antibodies that your immune system makes are IgM (these are your emergency response antibodies).

The presence of IgM indicates a very recent COVID infection- as opposed to the presence of IgG antibodies- which indicates a historic infection. Still- it’s better to rely on an antigen test than an IgM antibody test to identify newly infected people when you need a rapid test result. 

Will Humble Affordable Care Act, Medicaid, Prevention, Public Health, Public Health Law, Social Determinants, Wills Blog

Does Barrett’s Past Writing Shed Light on How She Might See the California v. Texas Case?

Soon to be Associate Justice Barrett wrote an article for the Notre Dame Law Scholarship Law Journal in 2017 that sheds some light on how she might think through the California v. Texas case. In the article, entitled “Countering the Majoritarian Difficulty“, Barrett seems to quite deferential to the executive and legislative branches. That may be a good thing for the ACA’s fate as restraint would tend to make her reluctant to overturn laws like the ACA.

However, on pages 80-84 of the article, she specifically suggests that Roberts’ majority opinion interpreting the penalty for not having health insurance a tax was flat out wrong – implying that she may believe that the ACA should be overturned on that basis:

In NFIB v. Sebelius… Chief Justice Roberts pushed the Affordable Care Act beyond its plausible meaning to save the statute. He construed the penalty imposed on those without health insurance as a tax, which permitted him to sustain the statute as a valid exercise of the taxing power; had he treated the payment as the statute did—as a penalty—he would have had to invalidate the statute as lying beyond Congress’s commerce power.

Barrett’s doesn’t opine on whether the ACA should have been considered constitutional based on congress’ authority to regulate interstate commerce… although that’s irrelevant because that’s not a question in front of the court in Texas v. California.

The fate of the ACA will soon rest with 9 appointed people.

Will Humble Affordable Care Act, Health Insurance, Medicaid, Prevention, Public Health, Public Health Law, Social Determinants, Wills Blog

With RBG’s Passing, the ACA May Be On Borrowed Time

The passing of Associate Justice Ruth Bader Ginsberg may very well have a profound impact on healthcare in the U.S. It appears likely that the Senate will confirm Amy Coney Barrett shortly. Perhaps it will be before the election, but if not, it will likely be in the early weeks after the election but before the new Senate opens session on January 3.

New justices are sworn in very quickly after they’re confirmed by the Senate. Prospective nominees are typically screened using criteria that expose their thoughts on major policy issues like Affordable Care Act. Their opinion history will also be reviewed. In any event, Barrett is far more likely than RBG to overturn the ACA.

A few weeks ago, the Supreme Court scheduled oral arguments on the future of the Affordable Care Act on November 10.  My bet is that they’ll postpone the case (called Texas v. Azar is now called California v. Texas) until Barrett is sworn in.

The case mostly revolves around the ACA’s individual mandate, which is a critical component to the rationale that the Supreme Court used back in 2012 to uphold the ACA. More about that in a bit.

The Court’s Changing Ideology

With RBGs passing and Barrett likely to be installed shortly, the US Supreme Court will have a much different cast of characters than it did when the ACA was originally upheld back in 2012 (by a 5-4 vote). Since then, Justice Gorsuch replaced Scalia and Justice Kavanaugh replaced Kennedy.  Both Justices Scalia and Kennedy voted against the ACA- so not much on that score has changed.  But, the late Justice Ruth Bader Ginsberg voted with the majority to uphold the ACA in 2012… so her replacement (Barrett) could prove pivotal.

Background on the 2012 Ruling

Chief Justice Roberts voted with the majority that upheld the law, but his majority opinion rested on the fact that the individual mandate to have health insurance also includes a penalty “tax “for those who don’t comply with the mandate. That tax was the “hook” that authorized the Act in that Ruling.

In the 2012 Ruling, Chief Justice Roberts wrote that:

“… the Affordable Care Act’s requirement that certain individuals pay a financial penalty for not obtaining health insurance may reasonably be characterized as a tax… because the Constitution permits such a tax, it is not our role to forbid it, or to pass upon its wisdom or fairness.” 

Chief Justice Roberts rejected the Administration’s argument that Congress’s authority to regulate interstate commerce provides the authority needed for the ACA to be constitutional (the Court struck down that argument 5-4).

The California v. Texas Case

The California v. Texas case which is scheduled to be heard in November was filed in 2018 by Texas, Arizona and 18 other states. The states claimed that once Congress eliminated the penalty underlying the individual mandate, the mandate must fall away because no revenue is directly produced.

Revenue production, noted Chief Justice Roberts in 2012, is a central component of the constitutional exercises of Congress’ tax power. The Trump administration and several Republican-led states including Arizona argue that the mandate to buy insurance unconstitutional, and lower courts have so far agreed.

Even if the individual mandate is found to be unconstitutional (or moot) by the court, the fate of the remaining provisions of the ACA in part hinges on a legal doctrine called “severability.” Basically, the question is, if one part of the law is found unconstitutional, must the rest of the law  also be found unconstitutional or would some portions remain intact? 

Arizona and other states say that the individual mandate is so central to the ACA that if the Supreme Court finds it unconstitutional, then the remainder of the 2,000-page ACA “must also fall.”

A key question is whether Barrett will agree with the lower courts. If she does, then the ACA will likely be ruled unconstitutional in its entirety because the individual mandate tax is gone and therefore the Act would likely be considered unconstitutional.  

But, it may not turn out like that.  For example, Judge Roberts ruled in his 2012 opinion that the Medicaid expansion of the ACA was severable from the rest.  Perhaps he will think the same this time but on a different provision?  Remember, Justice Roberts has already ruled that Congress’ ability to regulate interstate commerce doesn’t extend to the ACA.

The Impacts of the Demise of the ACA

A new white paper from the ASU College of Health Solutions explores how Arizona has benefitted from the ACA – and what’s at stake in the Supreme Court. For more information and references, view the full report.  Here’s a shorter Infographic with the Arizona impact.

A full repeal would have profound consequences for ordinary Americans. In addition to recent estimates that more than 23M people in the US who would lose coverage, repeal would eliminate essential consumer protections, Medicaid Expansion, Health Insurance Marketplaces, and extension of Dependent Coverage to age 26. Before the COVID-19 crisis erupted, coverage losses for Arizonans were estimated to be 297,000; additional coverage losses due to the pandemic have increased this estimate to 363,000.

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