Governor Declares Phase I: Stay At Home Order Expires

How Good Will Social Distancing Compliance be with Little or No Enforcement?

As you know, the governor declared that we are in Phase I and let his “stay at home” executive order (EO 2020-33) expire Friday night. He created a new one that took effect Saturday morning.  It encourages businesses and people to do the right thing to mitigate COVID spread, but has no compliance or enforcement criteria. Here’s the new Executive Order: EO 36.

While other governors are making modifications to the federal guidance withmore specific and measurable criteria like the number of contact tracers and persons tested per 100,000 people along with more specific hospital measurements to make decisions, our governor is using theraw federal guidance. The basic federal guidance uses the following simple criteria to determine when to move to Phase I:

  • A 14-day downward trend of influenza-like illnesses and COVID-like illnesses;

  • A 14-day downward trend of positive COVID-19 tests, assuming a flat or increasing volume of tests;

  • Robust testing, including antibody testing, for at-risk health care workers; and 

  • Hospital capacity that would allow medical professionals to treat all patients without crisis care.

The first and last of the bullets have been met. The middle two bullets are in a gray area. One could argue that they’ve been met, but one could also argue that they haven’t. Regardless, the Governor believes Arizona meets Federal Phase I and has pressed ahead by letting the former Stay at Home Order expire.

As of yesterday, all businesses can be open but they’re encouraged to implement a series of mitigation measures and have good plans in place. Cities and counties are prohibited from requiring anything more than what’s inEO 36.

There’s no specific enforcement provision in the new executive order. However it does include this language: “All law enforcement and regulatory agencies that have enforcement authority under existing state law should first focus on educating and working to promote best practices to accomplish this goal…”.

I don’t know what existing laws might be out there that would apply to businesses not doing the right thing. Maybe there are some, but I don’t know what they might be. We’ll see in the coming days whether bars, restaurants etc. (and their customers) behave responsibly. If they don’t, we’ll be back to square one probably.

Perhaps you saw the news stories about bars along Mill Avenue in Tempe that were disregarding social distancing and infection control best practices. If behavior like that proliferates, then we’re all in trouble. I sincerely hope this kind of behavior doesn’t metastasize.

Editorial note: There has been a lot of public debate and discussion about what the proper timing is to relax some of the Stay at Home interventions. Basically- lots of talk about WHEN to allow things to open. Far less discussion has been about HOW they open.

To me, thehowquestion is more important than thewhenquestion. It’ll be super important that retail stores, salons, and restaurants have good, effective and evidence-based mitigation measures in place when they open. So, basically, I’d like to see more thought and debate put into providing specific guidance and compliance criteria for how these businesses can open responsibly.

Executive Order Enhances Skilled Nursing & Assisted Living COVID Reporting Requirements

Last week the governor issued an executive order requiring skilled nursing and assisted living facilities to: 1) notify family members if a resident of the facility tests positive for the virus; 2) notify applicants of the number and presence of COVID-19 cases in the facility; and 3) notifying residents and families about the presence of the disease when facility transfers are being considered.

PS: CMS released a new toolkit of best practices in preventing the spread of COVID-19 in nursing homes.

Dr. Joe Gerald’s Latest Predictive Model Run

Dr. Joe Gerald from the University of Arizona’s Mel & Enid Zuckerman College of Public Health has been Johnny On the Spot when it comes to putting together predictive modeling for Arizona ever since the very beginning. He takes several of the existing predictive models that are out there, examines the AZ model runs and does some interpretation to give the results some life.

Here’s the latest model run. I encourage you to look at the 6-page model run, but if you’re out of time, here’s what Dr. Gerald puts in his summary this week:

Current social distancing restrictions have slowed viral transmission, but not sufficiently to prevent newly reported cases, hospitalizations, and ICU utilization from increasing.

Absolute levels of community-driven viral transmission remain high as evidenced by substantial numbers of newly reported cases.

For many locales, additional social distancing restrictions are likely needed to prevent newly reported cases, hospitalizations, and ICU utilization from increasing and ultimately exceeding local health system capacity.

For all locales, lifting social distancing restrictions would likely accelerate the pace of viral transmission leading to increasing case counts and hospital utilization.

While adequate hospital capacity exists to care for some increase in severely ill patients, a higher case count will narrow our safety margin.

Growing evidence suggests that Pima County has slowed viral transmission such that newly reported cases are declining and a peak has been reached.

COVID-19 testing capacity (PCR and serology) has meaningfully increased over the past week. However, the PCR test positive rate remains above 3% indicating capacity is not adequate to meet clinical and public health demands.

Diagnostic v Serological Testing for COVID-19

There are two types of tests available for COVID-19 that can detect whether a person is or has in the past been infected with the SARS-CoV-2 virus (which causes COVID-19 illness):

  • Polymerase chain reaction (PCR) testing, which tests for active infection; and

  • Serology testing for antibodies against SARS-CoV-2.

Diagnostic PCR Testing

The most commonly used and reliable test for diagnosis of COVID-19 has been the RT-PCR test performed using nasopharyngeal swabs or other upper respiratory tract specimens, including throat swab or, more recently, saliva.

The PCR test uses a long nasal swab to collect a specimen in the nose, throat, or other areas in the respiratory tract to determine if there is an active infection with SARS-CoV-2.  This test is useful for determining who has an active infection and identifies people who are contagious to others.

Antibody Testing

Serology testing uses either a drop of blood or a blood draw and is used to determine if a person has been an infection in the past.  IgM is the first antibody that is formed against an antigen, so it appears on tests first, usually within 1-2 weeks. The body then forms IgG, which appears on tests about 2 weeks after the illness starts. IgM usually disappears from the blood within a few months, but IgG can last for years. Some antibody tests test for IgM and IgG, and some only test for IgG.

Serological diagnosis is especially important for patients with mild to moderate illness who may present late, beyond the first 2 weeks of illness onset. Serological diagnosis also is becoming an important tool to understand the extent of COVID-19 in the community and to identify individuals who are immune and potentially “protected” from becoming infected.

Using Test Results to Inform Public Health Interventions

The federal government has issued guidance for states to use as they make decisions about whether to tighten or loosen interventions like stay at home orders. Some of the criteria in that guidance includes the trajectory of documented cases (as measured by these tests). 

For example, gating criteria number 2 states that states should document a: 1) downward trajectory of documented cases within a 14-day period; or 2) a downward trajectory of positive tests as a percent of total tests within a 14-day period (flat or increasing volume of tests) before moving to a “Phase I Opening”.

However, the Gating Criteria aren’t specific about whether “positive tests” are just the RT-PCR nasal swab test or whether the criteria can include antibody tests.

The percent positives for the RT-PCR tests and the serology tests are quite different (the percent positive for RT-PCR tests in AZ is currently 8.1% while the serology is 3.7%).  That makes sense, because the PRC tests are conducted on persons that are symptomatic and mostly in clinical settings while the serology tests are usually done on asymptomatic folks. And remember, the serology test (if positive) suggests that the person was infected at some point in the past, which could be weeks or even months ago.

So, how should we interpret these tests for the purposes of determining whether we meet Gating Criteria Number 2?

The only thing that makes sense is to track the trajectory of the RT-PCR tests and Serology tests separately– and look at the trends separately.  That’s because each of these tests are for different purposes and are used on different populations.  Both are valid for their own intent, but they shouldn’t be put in the same data set.

We urge the ADHS and governor to track and interpret PCR and Serology tests separately…  and keep the data sets separate when looking at data trends for the purposes of determining whether we meet the benchmarks in the federal guidanceThe ADHS data dashboard is now tracking these data sets separately – so that’s a good thing.

Hopefully that stands for decision-making purposes for determining when Arizona is ready for Phase I under the federal guidance.

___________________

Related Journal Article of the Week

Interpreting Diagnostic Tests for SARS -CoV-2

JAMA. Published online May 6, 2020. doi:10.1001/jama.2020.8259

AHCCCS To Share Medicaid Data with UA for Research Purposes

AHCCCS recently signed an agreement with the University of Arizona to make Medicaid demographic data sets available to the University for research purposes. AHCCCS maintains a similar data-sharing agreement with Arizona State University Center for Health Information Research.

Both contracts are managed through the Arizona Board of Regents. A big shout-out to AzPHA member State Senator Heather Carter for her work on facilitating the Agreement. It will go a long way toward facilitating additional research and analysis of various aspects of the state’s health care delivery system- research that could be used to improve the performance of the Medicaid system

The agreement complies with state and federal laws regarding the disclosure of confidential, individually identifiable health information. Requests for data from external customers outside of the U of A, should continue to be directed to ASU CHIR.

Excellent idea that will help AHCCCS learn more about how to keep their member healthy, provide valuable data for our university faculty to conduct valuable population health research, and put our university system in a better position to get new grant awards from NIH, PCORI and other sources.

Great example of using the power of data analysis to improve our ability to address health disparities!

UK and Germany Begin Clinical Trials for SARS CoV2 Vaccine

UK and Germany Begin Clinical Trials for SARS CoV2 Vaccine

A clinical trial for a coronavirus vaccine candidate developed by researchers at the University of Oxford will begin today in the U.K.  The start of human testing in the U.K. coincides with Germany’s regulator, the Paul-Ehrlich-Institut, giving German biotech BioNTech and partner Pfizer the green light to start the first coronavirus vaccine clinical trial in the country.

The first part of the clinical study in Germany will test variants of the vaccine in 200 healthy volunteers aged 18–55 years. The second part of the study will be expanded to include volunteers who are at an increased risk of infection or increased risk of serious COVID-19 disease.

Vaccine development usually takes more than five years. We can’t wait that long for this one, and the researchers are working under a 12–18 months development timeline that will pre-clinical and clinical evaluation, and manufacturing process development.

Supreme Court Scheduled to Hear the ACA Lawsuit

It’s now called California v. Texas because the federal government isn’t defending the ACA

In the coming weeks, the Supreme Court is scheduled to receive written briefs in the Affordable Care Act repeal lawsuit. The case is now called officially called California v. Texas (formerly Texas v. US, and before that Texas v. Azar).

California and others who are seeking to preserve the ACA are due to deliver opening briefs on May 6th, while Texas, AZ, and the other states who are seeking to repeal the ACA will deliver their briefs on June 25th. Oral arguments will be heard by the Court this fall.

One Stop Shop for PPE Donations

There are some entities that have been trying to make and donate PPE to healthcare workers and others in most need. The UA Center for Rural Health has developed a one stop shop where and how you can best contribute. The site breaks down PPE donation sites by county, tribal health center, and under-served populations. There are also places to request PPE for providers/first responders, especially those in rural and tribal areas. 

If you know of a county, tribe, or group collecting donations to give to under-served populations and those most in need, please let them know! They’re happy to add relevant information to this resource hub

An area of acute need is the Navajo and Hopi Nations.  They are in dire need of mask donations and can also use help from volunteers. For more information visit www.NavajoHopiSolidarity.org 

ADHS Suspends, then Reinstates Arizona’s COVID-19 Modeling Working Group

Updated 3:00 pm May 7

Back in late April the ADHS released a model developed by the “COVID-19 Modeling Working Group” (Authors: Tim Lant, PhD, MAS; Megan Jehn, PhD; Esma Gel, PhD; Anna Muldoon, MPH; Heather Ross PhD, DNP, ANP-BC and several researchers at the UA including Dr. Joe Gerald).

The team developed an Arizona-specific predictive model providing state-specific projections of new cases and deaths based on the best available science and Arizona case data. The most recent model run produced projected daily counts for infected individuals, ICU use, and deaths for five different scenarios.  The state modeling team report also provides scenario-based estimates of resource needs for hospital beds, ICU beds, and ventilators but doesn’t include a capacity assessment.  Very solid work being done by top talent in the field that is very useful for decision-making purposes.

Astonishingly, the ADHS sent a letter to the Working Group last night hours after the governor and health director’s press conference ending the stay at home order. ADHS told the modeling team to stop their work, discontinue producing predictive models, and to return the data that the working group was given by the ADHS. Interestingly, the request came hours after the governor and director Christ announced that they were fully ending the stay at home order on May 15, at which time bars, restaurants etc. will all allowed to be open. They will be encouraged to implement CDC mitigation measures but there won’t be any enforcement.

The letter asking them to stop work didn’t provide any reason for the request except that it was at the direction of ADHS’ senior leadership.

The only remaining predictive model that the state health department is now using has been developed by FEMA.  Neither that model nor the predictive modeling results from the FEMA model are publicly available.

Last night’s action to disband the Arizona COVID-19 Modeling Working Group begs the question of whether the Modeling Working Group was discontinued because they had been producing results that were inconsistent with messaging and decisions being made by the executive branch?

May 7 Update 12:00 pm

Yesterday afternoon, less than 24 hours after being asked to “pause” their work, Arizona State University released the following statement:

“During the pandemic, Arizona State University has conducted modeling data research on the impact of the COVID-19 pandemic on Arizona. In April, ASU, along with researchers from UA, were contacted by ADHS to form an ADHS Modeling Working Group that provided estimates on the number of COVID-19 cases, hospital beds, ICU beds, ventilators and economic impact assessments. ASU’s was one of several public health models ADHS used for guidance on its public health decisions. With the Governor’s announcement of updated Arizona COVID-19 guidelines on May 4th, the working group was notified by ADHS to discontinue its services until the fall. Moving forward, ASU will continue to perform its COVID-19 research projects, and will make these updates publicly available during the ongoing COVID-19 pandemic.”

We applaud ASU for continuing their predictive modeling work despite the request that they discontinue their work. Sadly, the Team will no longer have access to some of the data sets that are in the sole possession of the ADHS, but we have no doubt that the Team will continue to produce high quality work that will be inform the people of Arizona and some of our elected and appointed officials.

Kudos to the COVID-19 Modeling Working Group!

May 7 Update 3:00 pm

The ADHS released the following statement:: “Earlier today we communicated with the members of the University modeling team and we’re pleased to announce an ongoing partnership to continue providing models….”

So… it appears that the media attention on this issue over the last several hours triggered an attitude adjustment among the senior leadership of ADHS and the Team will continue to receive data and produce more predictive COVID-19 models for the people of Arizona.

Cheers to the 1st Amendment!

Stay At Home Order Ends May 15

Mitigation will be encouraged (but not required) and there will be no enforcement- a big mistake

Last week the governor extended his previous ‘stay at home’ executive order through May 15 (See EO 2020-33). The previous EO had been scheduled to expire on April 30.  Then yesterday at a news conference he made some changes that loosened the Stay At Home Order.

Under the new Stay at Home Order barbershops, hair salons, and other service industry and retail stores can open for business this Friday (May 8) as long as they have mitigation measures in place like social distancing and occupancy limits etc. On May 11 (this coming Monday) restaurants can start offering dine-in service as long as they have mitigation measures in place. Bars are not included, although it’s unclear whether that will be determined by the category of their liquor license or some other criteria.

Earlier statements by the governor suggested that he intends to use the guidance issued by the president about 2 weeks ago to make decisions about when to lift the stay at home order.  That guidance suggests that states meet the following criteria before lifting stay at home orders:

  • A 14-day downward trend of influenza-like illnesses and COVID-like illnesses;

  • A 14-day downward trend of positive COVID-19 tests, assuming a flat or increasing volume of tests;

  • Robust testing, including antibody testing, for at-risk health care workers; and 

  • Hospital capacity that would allow medical professionals to treat all patients without crisis care.

The first and last of the bullets have been met. The middle two bullets are in a kind of gray area where one could argue that they’ve been met, but one could also argue that they haven’t.

Editorial note: There has been a lot of public debate and discussion about what the proper timing is to relax some of the Stay at Home interventions. Basically- lots of talk about WHEN to allow things to open. Far less discussion has been about HOW they open. To me, the how question is more important than the when question.

It’ll be super important that retail stores, salons, and restaurants have good, effective and evidence-based mitigation measures in place when they open. So, basically, I’d like to see more thought and debate put into providing specific guidance and compliance criteria for how these businesses can open responsibly. Furthermore (and most importantly) there needs to be robust enforcement of mitigation measures. However, today’s Order doesn’t include any enforcement provisions at all!

The state health department put together a 1-page set of guidelines for retail businesses as they prepare for partial operations starting next week. The recommendations (not requirements) include enhanced sanitation and physical distancing steps customers and business owners should take to minimize the risk of spreading the virus. Perhaps more detailed guidance is on the way?