Hydroxychloroquine & Chloroquine Get FDA Emergency Use Authorization as COVID-19 Treatments

Last week the FDA issued an emergency use authorization for hydroxychloroquine and chloroquine as treatments for COVID-19. The authorization allows the drugs to be donated to the Strategic National Stockpile and distributed as well as prescribed by doctors to hospitalized adult COVID-19 patients as appropriate.  They could have been used off-label before the authorization, but this determination remove the SNS administrative barrier.

On Saturday the governor issued an executive order limiting hydroxychloroquine prescriptions to people that need it for treatment (e.g. Lupas or COVID) and clarified that it can’t be used for prophylaxis (prevention).  Good idea.

The CDC has a web page that summarizes the trials underway including for Remdesivir, which is an investigational intravenous drug with broad antiviral activity that inhibits viral replication through premature termination of RNA transcription and has in-vitro activity against SARS-CoV-2 and in-vitro and in-vivo activity against related coronaviruses.  More information on trials can be found at:  https://clinicaltrials.gov/.

The CDC is Recommending People Wear Cloth Masks Whether They’re Symptomatic or Not

Is There Evidence for this Intervention?

  • People that have respiratory symptoms or fever should stay home and not be out and about right now (with or without a mask).

  • Cloth masks or home-made masks and scarfs are fine for asymptomatic persons to wear in the community (but likely provide little protection for the wearer or community members).

  • Members of the community should not wear manufactured medical masks if they are asymptomatic. Doing so puts additional pressure on the PPE supplies and putting additional strain on health care workers.

  • However, cloth masks might remind people to stop touching their faces and also remind people to keep their distance from others (perhaps the mask can provide a visual queue to keep some distance).

The CDC is now recommending the voluntary use of cloth face masks by everyone in the community regardless of whether they’re sick. 

There is some evidence to support the use of cloth masks for people that have any respiratory symptoms (during this pandemic) as a recent study supports the use of surgical face masks to prevent coronavirus transmission from symptomatic individuals.  There’s widespread consensus that people working in healthcare and people that have any respiratory symptoms in the community should wear facemasks.   But- there’s little if any evidence to support the use of face masks for those who are not symptomatic in the community.  

Given the shortage of PPE in healthcare settings and the demand that would be placed on the supply chain from widespread use of manufactured medical masks, the only reasonable recommendation is for people without symptoms to wear cloth masks, scarves or homemade masks- not manufactured medical masks.

There’s very limited data on the efficacy of cloth masks. There are some small studies (1, 2, 3) showing that cloth masks can provide some level of marginal protection against particles which can contain viruses. If a covering gets wet (even from the moisture emitted when a person exhales) the fabric could be more likely to transmit the virus.

One randomized trial compared medical masks, 2-layer cotton cloth masks, and usual practice in hospital health care workers (n=1607).  The cloth masks were 2-layer cotton masks.  Participants were asked to wash them daily with soap and water.  The study found that the highest rates of influenza-like illness were in the cloth mask group (RR =13.0 compared to the medical mask wearers).

Infections were also higher in the cloth mask group compared to the usual practice group. Cloth masks also had higher rates of laboratory confirmed virus in participants (RR 1.7 compared with the medical mask group).  Penetration of cloth masks by particles was almost 97% compared to 44% in medical masks.

Healthcare Worker Personal Protective Equipment Still a Challenge

Arizona has now received 75% of our allocation of personal protective equipment (gloves, masks, gowns, hoods) from the Strategic National Stockpile.  The goods come in to the ADHS warehouse from the SNS and are shipped to the county/tribal health departments, who then prioritize where the PPE will go.  Most are continuing to prioritize inpatient facilities.

In the mean-time, individual hospitals, community health centers, skilled nursing facilities and healthcare providers of all sizes are continuing to pursue PPE from their usual wholesalers.  I presume that the state of Arizona is doing the same.

The bottom line is that there is only so much PPE in the world and it is in super high demand everywhere.  The primary manufacturers are in China, which is now just in the process of getting their manufacturing industries up and running.

It’s unfortunate- but for the duration of the pandemic healthcare providers of all types won’t have the personal protective equipment that they have been accustomed to having their entire career. 

The CDC has a website with some practical guidance to help healthcare providers conserve their PPE  – they call it strategies to optimize the use of PPE. The site has separate guidance for masks, gloves, gowns, respirators, and ventilators.  There’s also a PPE Burn Rate Calculator to help facilities calculate the use as they go.

Most facilities are probably already using Contingency Level conservation methods- and there is a good chance that’ll progress to the Crisis Level at some point in the next few weeks.  Here’s a link to the state’s Contingency PPE Guidance.

Updated Case and Infection Fatality Ratios for COVID-19

Last week The Lancet published a new study examining the case and infection fatality ratios for the pandemic.  The case fatality ratio is an estimate of the fraction of people that have been confirmed to have the disease that end up passing away.  The infection fatality ratio on the other hand is the fraction of people that pass away that have been infected with the virus (the infection fatality ratio includes asymptomatic cases).

The author’s best estimate of the case fatality ratio is 1.38%. Of course, there’s a big difference in the case fatality ratio by age. The ratio was a lot bigger in older age groups, with a CFR of 13% among people aged 80 years or older.  Their estimated overall infection fatality ratio is 0.66%, also with an increasing profile with age.

State Allocates Some of the $100M in Rainy Day Money

On Friday state agencies told the legislature what they intend spend some of the $100M in rainy day funds on. So far, they’ve allocated $35M from the $50M medical fund and $6.7M from the other $50M contingency fund.

They’re planning to spend $10M on ventilators, and $8.5M for medical masks, $5.8 million to help county health departments, and $1.2 million to tribes for local preparedness and response.  Another $1.1M is going to the Boys & Girls Clubs & $2.4M to the YMCA to expand childcare options for essential workers.  $3M will go toward buying lab equipment and other supplies for testing.  $1.8M is headed to DEMA & $750K for a “hospital build-out”.

You can see the spending plan for both of the $50M funds here.

What Health Insurance Options Are Out There for Folks that Have Been Laid Off?

Beyond the public health impact of the virus itself, the social distancing interventions are causing their own public health impacts by adversely impacting the social determinants of health. When people lose their ability to make a living it can cause a cascade of harmful outcomes. It’s a good thing that the recent $2.2T fiscal stimulus is on the way (especially the increase in unemployment insurance benefits) – but that’s just a patch.

Among things that folks that have been laid off are worrying about is health insurance.  Some people that have been laid off may be OK for now if their employer is temporarily carrying their group insurance (at least for April).  Most people that have been laid off will probably be losing their employer-based health insurance at the end of the month in which they were laid off.  Those folks have a few different options.

Medicaid

Medicaid may be an option for some folks recently laid off.  AHCCCS is recommending that people apply for AHCCCS health insurance as soon as they’re laid off.  To apply online, folks can visit the Health-e-Arizona PLUS online application portal.  Here’s AHCCCS’ Enrollment Information Webpage with a summary of the qualifying criteria including  income eligibility requirements

In most instances for initial eligibility determinations, the actual (or anticipated) income to be received in the application month is considered. The application form allows you to indicate that you’ve lost your income. AHCCCS has stated that additional unemployment insurance payments and the upcoming stimulus checks won’t be counted as income when determining medical eligibility, so that’s good. 

The bottom line is that a lot of things are in flux right now and there’s nothing to lose by applying right away.  People can schedule a free phone appointment with a certified assister to learn more. Call 1-800-377-3536 or by visiting www.coveraz.org/connector.

Marketplace Insurance

People recently laid off can also buy health insurance through the federal marketplace under the Affordable Care Act.  Enrolling in Marketplace plans is usually limited to the open enrollment period, but when a person is laid off and loses their employer based health insurance it’s called a “qualifying event” and they can buy Marketplace insurance even though it’s not open enrollment.  So that’s another option.  And remember, Marketplace plans come with subsidies for folks that financially qualify.

COBRA

For decades there’s been a law in place called COBRA – which allows people to maintain their employer-related group health insurance- except that they need to pay both the employer and employee side of the premium (which can be expensive). So, folks that have been laid off can ask their employer for a COBRA application and get coverage that way.

Other Help

There are other programs out there that can help people with resources in times of need like this.  A good place to explore the potential benefits is a website called Arizona Self Help.  It’s a free and easy way to find out if your family can get help from 40 different health and human services programs. The website provides Program list/descriptions, Contact information, List of items you may need to bring to an eligibility interview, and Program applications.

Does Your Blood Type Influence Whether You’ll Get COVID-19?

Maybe.

Researchers in China have discovered some interesting evidence suggesting that persons with Type A blood have a higher risk of getting COVID-19 when compared to non-A blood type people.  The researchers in China compared the blood group distribution in 2,173 patients with COVID-19 from three hospitals in China with that in normal people from the corresponding regions near those hospitals.

Their Meta-analysis on the pooled data (which has not been peer-reviewed) found that blood group A had a statistically significantly higher risk for COVID-19 (odds ratio 1.20) compared with non-A blood groups.  Blood group O had a statistically significant lower risk for the disease (odds ratio 0.67) compared with non-O blood groups.

Their report concluded that “People with blood group A have a significantly higher risk for acquiring COVID-19 compared with non-A blood groups, whereas blood group O has a significantly lower risk for the infection compared with non-O blood groups.” 

However, always remember to check the odds ratio on studies like this. In this case you’ll see that the odds ratio for the blood group A is 1.2 which basically means that folks with Type A blood are 20% more likely to get the illness.  The odds ratio for the Group O folks suggests that they are roughly 30% less likely to be confirmed as a case. Not exactly a huge difference, but it was statistically significant.

Also, the study hasn’t been peer-reviewed which means that it hasn’t been examined for its accuracy and shouldn’t be used to guide clinical practice.

State Legislature Adjourned – for Now

Last Monday, the state legislature completed its work to pass the budget for the fiscal year and adjourned until April 13.

With a few exceptions, the “skinny” budget strips out one-time funding and increases spending in areas that require annual adjustments such as K-12 education and AHCCCS. The budget also continues to phase in the 20% teacher pay increases and the restoration of district and charter additional assistance in K-12 education.  

Using Federal Child Care Block Grant Funds, the budget funds childcare subsidies for 3,000 additional children and increases rates for childcare providers with quality ratings of 3 to 5 stars.

The bare bones budget leaves out several of our priorities like:  

  • Providing comprehensive dental care for pregnant moms participating in Medicaid/AHCCCS

  • Restoring supports to grandparents and other kinship caregivers who step in when parents are unable to care for their children.

  • Raising the childcare subsidy reimbursement rates for all childcare providers to help working parents with high out-of-pocket costs

In response to the evolving issues surrounding COVID-19, the legislature authorized $50 million for deposit into a new “Contingency and Safety Net Fund”. These funds may be spent only after the governor declares a state of emergency. It’s separate and apart from the $55M that the ADHS received from the rainy day fund two weeks ago.

These new funds are restricted to housing assistance, including eviction and foreclosure prevention; services for persons experiencing homelessness, including shelter, clothing, food and transportation; food bank operations; and assistance to businesses with fewer than 50 employees, health care providers and nonprofit organizations.

That’s good because these social distancing interventions are having a profound impact on the social determinants of health and the safety net programs mentioned in the new Contingency and Safety Net Fund are very important.

Does Today’s “Stay Home, Stay Healthy, Stay Connected” Executive Order Change Anything?

Let’s Find Out

This afternoon the Governor issued an executive order stating the Arizonans “shall limit their time away from their place of residence or property” with some exceptions. Let’s explore what those exceptions are, ok?

One exception category is for what’s called “essential activities”. Another category is “essential functions”. A third exemption category is for what’s called “essential business services”. So, the stay at home order covers everything but those exceptions.

Let’s unpack what those words essential activities, essential functions, and essential business services mean under the Order (the exceptions). As you explore the list of exceptions try to find something that’s not on the list. At the end, you can answer this question for yourself, “does this make any real changes to what was happening before the Order? “

Let’s dig into the exemptions:

  • Essential Infrastructure Operations: includes but is not limited to: food production, distributions, and sale; construction (including, but not limited to, construction required in response to this public health emergency, hospital construction, construction of long-term care facilities, public works construction, and housing construction); building management and maintenance; landscape management; airport operations; operation and maintenance of utilities, including water, sewer and gas; electrical (including power generations, distribution, and production of raw materials); distribution centers; oil and biofuel refining; roads, highways, railroads and public transportation; ports; cybersecurity operations; flood control; solid waste and recycling collection and removal; internet, video and telecommunications systems (including the provision of essential global, national, and local infrastructure for computing services, business infrastructure communications and web-based services). Essential Infrastructure shall be construed broadly to avoid any impacts to essential infrastructure, broadly defined.

  • Essential Businesses and Operations: includes but is not limited to Healthcare and Public Health Operations, Human Services Operations, Essential Governmental Functions and Essential Infrastructure Operations as well as the following:

    • Stores that sell groceries and medicine: Grocery stores, pharmacies, certified farmers’ markets, farm and produce stands, supermarkets, convenience stores, and other establishments engaged in the retail sale of groceries, canned food, dry goods, frozen foods, fresh fruits and vegetables, pet supplies, fresh meats, fish and poultry, alcoholic and non-alcoholic beverages, and any other household stores that sell groceries, medicine, including medication not requiring a medical prescription, and also that sell other non-grocery products, and products necessary to maintaining the safety, sanitation and essential operation of residences and Essential Businesses and Operations.

    • Food, beverage and agriculture: Food and beverage manufacturing, production, processing, and cultivation, including farming, livestock, fishing, baking; and other production of agriculture, including cultivation, marketing, production, and distribution of animals and goods for consumption and businesses that provide food, shelter and other necessities for life for animals, including animal shelters, rescues, shelters, kennels and adoption facilities.

    • Outdoor recreation activities: any outdoor recreation area, park, site or trail that provides opportunities for outdoor recreation with social distancing such as walking, hiking and biking. This includes golf courses if restrictions on food and beverage service under Executive Order 2020-09 are followed.

    • Organizations that provide charitable and social services: Businesses and religious and secular nonprofit organizations, including food banks, when providing food, shelter and social services and other necessities of life for economically disadvantaged or otherwise vulnerable individuals who need assistance as a result of this emergency and people with disabilities.

    • Media: Newspapers, television, radio and other media services.

    • Gas stations and businesses needed for transportation: Gas stations and auto-supply, auto-repair and related facilities including (including vehicle sales), truck stops, and bicycle shops and related facilities.

    • Financial institutions: Banks, currency exchanges, consumer lenders, including but not limited to payday lenders, pawnbrokers, consumer installment lenders and sales finance lenders, credit unions, appraisers, title companies, financial markets, trading and futures exchanges, affiliates of financial institutions, entities that issue bonds, related financial institutions and institutions selling financial products.

    • Hardware and supply stores: Hardware stores and businesses that sell electrical, plumbing and heating materials.

    • Critical trades: Building and Construction Tradesmen and Tradeswomen and other trades including but not limited to plumbers, electricians, exterminators, cleaning and janitorial staff for commercial and governmental properties, security staff, operating engineers, HVAC, painting, moving and relocations services, and other service providers who provide services that are necessary to maintaining the safety, sanitation, and essential operation of residences, essential activities and essential businesses and operations.

    • Mail, post, shipping, logistics, delivery and pick-up services: Post offices and other businesses that provide shipping and delivery services, and businesses that ship or deliver groceries, food, alcoholic and non-alcoholic beverages, goods or services to end users or through commercial channels.

    • Educational institutions: Educational institutions-including public and private pre-K-12 schools, colleges and universities-for purposes of facilitating distance learning, performing critical research, or performing essential functions, provided that social distancing of six-feet per person is maintained to the greatest extent possible. This Executive Order is consistent with and does not amend or supersede any order by the Governor and Superintendent in effect to close schools, except that affected schools are ordered closed through April 10, 2020.

    • Laundry services: Laundromats, dry cleaners, industrial laundry services and laundry service providers.

    • Restaurants for consumption off-premises: Restaurants and other facilities that prepare and serve food, but only for consumption off-premises, through such means as in-house delivery, third-party delivery, drive-through, curbside pick-up and carryout. Schools and other entities that typically provide food services to students or members of the public may continue to do so on the condition that the food is provided to students or members of the public on a pick-up and take away basis only. Schools and other entities that provide food services under this exemption shall not permit the food to be eaten at the site where it is provided or at any other gathering site. This order is consistent with and does not supersede Executive Order 2020-09.

    • Supplies to work from home: Businesses that sell, manufacture, or supply products needed for people to work from home or conduct distance learning.

    • Supplies for Essential Businesses and Operations: Businesses that sell, manufacture, or supply other Essential Businesses and Operations with the support or materials necessary to operate, including computers, audio and video electronics, household appliances; IT and telecommunication equipment; hardware, paint, flat glass; electrical, plumbing and heating material; sanitary equipment; personal hygiene and products; food, food additives, ingredients and components; medical and orthopedic equipment; optics and photography equipment; diagnostics, food and beverages, chemicals, soaps and detergent; firearm and ammunition suppliers and retailers for purposes of safety and security.

    • Transportation: Airlines, taxis, transportation network providers (such as Uber and Lyft), vehicle rental services, paratransit, and other private, public and commercial transportation and logistics providers necessary for all categories of “Essential Operations” as defined in this order.

    • Home-based care and services: Home-based care for adults, seniors, children, and/or people with developmental disabilities, intellectual disabilities, substance use disorders, and/or mental illness, including caregivers such as nannies who may travel to the child’s home to provide care and other in-home services including meal delivery.

    • Residential facilities and shelters: Residential facilities and shelters for adults, seniors, children and/or people with developmental disabilities, intellectual disabilities and substance use disorders and/or mental illness.

    • Professional and personal services: Professional services, such as legal services, accounting services, insurance services, personal hygiene services (including barber shops and salons) with additional sanitization precautions as recommended for businesses by the Arizona Department of Health Services and real estate services (including appraisal and title services).

    • Day care centers for employees exempted by this Executive Order: Day care centers providing care for individuals serving in any essential services category.

    • Manufacture, distribution and supply chain for critical products and industries: Manufacturing companies, distributors and supply chain companies producing and supplying essential products and services in and for industries such as pharmaceutical, technology, biotechnology, healthcare, chemicals and sanitizations, waste pickup and disposal, agriculture, food and beverage, transportations, energy, steel and steel products, petroleum and fuel, mining, construction, national defense, communications as well as products used by other Essential Businesses and Operations.

    • Hotels and motels: Hotels and motels, to the extent used for lodging and delivery or carryout food services.

    • Funeral services: Funeral, mortuary, cremation, burial, cemetery and related services.

  • Essential Governmental Functions: includes but is not limited to: park personnel that provide admission, maintenance and operation of park facilities that provide outdoor recreation; all first responders, emergency management personnel, emergency dispatchers and those supporting 911 services; court personnel, law enforcement and corrections personnel; hazardous materials responders; child protection and child welfare personnel; housing and shelter personnel; military and other governmental employees working for or to support Essential Businesses and Operations. Essential Government Functions means all services provided by the State or any county, city, town or political subdivision thereof and needed to ensure the continuing operation of the government agencies or to provide for or support the health, safety and welfare of the public. Essential Government Functions also includes contractors performing or supporting such functions. Each government body shall determine its Essential Governmental Functions and ensure a plan is in place for the performance of these functions. This order does not apply to the United States government or to a tribal entity, however, any employee, official or contractor of the United States government shall not be restricted from performing their functions under law.

  • Healthcare and Public Health Operations: includes but is not limited to: hospitals; clinics; dental offices; pharmacies; public health entities, including those that compile, model, analyze and communicate public health information;  pharmaceutical, pharmacy, medical device and equipment, and biotechnology companies (including operations, research and development, manufacture and supply chain); organizations collecting blood, platelets, plasma, and other necessary materials; eye care centers, including those that sell glasses and contact lenses; home healthcare services providers; mental health and substance use providers; other healthcare facilities and suppliers; providers of any related and/or ancillary healthcare services; entities that transport and dispose of medical materials and remains; manufacturers, technicians, logistics and warehouse operators, and distributors of medical equipment, personal protective equipment (PPE), medical gases, pharmaceuticals, blood, platelets and plasma products, vaccines, testing materials, laboratory supplies, cleaning, sanitizing, disinfecting or sterilization supplies, and tissue and paper towel products; veterinary care and all healthcare services provided to animals. This includes doctors, nurses and any other classification of medical personnel necessary to operate those functions in this category. This category of essential services shall be construed broadly to avoid any impacts to the delivery of healthcare, broadly defined. Healthcare and Public Health Operations does not include fitness and exercise gyms.

  • Human Services Operations: includes but is not limited to: long-term care facilities; residential settings and shelters for adults, seniors, children and/or people with developmental disabilities, intellectual disabilities, substance use disorders, and/or mental illness; transitional facilities; home-based settings to provide services to individuals with physical, intellectual, or/or developmental disabilities, seniors, adults, and children; field offices that provide and help to determine eligibility for basic needs including food, cash assistance, medical coverage, child care, vocational services, rehabilitation services; developmental centers; adoption agencies; businesses that provide food, shelter, and social services, and other necessities of life for economically disadvantaged individuals, individuals with physical, intellectual and/or developmental disabilities, or otherwise vulnerable individuals. Human Services Operations shall be construed broadly to avoid any impacts to the delivery of human services, broadly defined.

Whew. So, those are the essential business and other services. Now let’s tackle the exceptions in the essential activities category. Essential activities are exempted even if the activity isn’t associated with an essential business or other service.

  • Obtaining necessary supplies and services for family, household members and pets, such as groceries, food and supplies for household consumption and use, supplies and equipment needed to work from home, assignments for completion of distance learning and products necessary to maintain safety, sanitation and essential maintenance of the home, residence. 

  • Engaging in activities essential for health and safety, including things such as seeking medical, behavioral health or emergency services and obtaining medical supplies or medication. 

  • Caring for a family member, friend, or pet in another household or residence, which includes but is not limited to transportation for essential health and safety activities and to obtain necessary supplies and services for the other household. 

  • Engaging in outdoor exercise activities, such as walking, hiking, running, biking or golfing, but only if appropriate physical distancing practices are used.

  • Attending work in or conducting essential services which includes but is not limited to transporting children to child care services for attending work in an essential service.

  • Engaging in constitutionally protected activities such as speech and religion, the democratic process to include voting any legal or court process provided that such is conducted in a manner that provides appropriate physical distancing to the extent feasible.

Now, perhaps you can name a service or activity that’s not exempted. Can you? There are some but you need to be creative to find them.

Oh, also, if someone is doing something that’s not on the exception list above, the Order says that “no person shall be required to provide documentation or proof of their activities to justify their activities under the (this) Order.”

Now answer the question for yourself: “does this new Order make any real changes to what’s happening right now”?

COVID-19 Bailout Bill

Provides some relief for the social determinants of health

The Coronavirus Aid, Relief, and Economic Security (CARES) Act, was passed and signed last Friday. It includes important provisions to mitigate the sharp economic decline and threat to the social determinants of health unfolding right now.

It includes an expansion of unemployment benefits, direct payments to low- and middle-income families, funds for states to help address the large budget holes and investments across a range of existing programs that can help respond to the current crisis.

Here are some of the specifics:

  • Provides a federally funded $600/week benefit increase through July 31 for people qualifying for unemployment insurance (this is a big deal because Arizona’s existing benefit is the lowest in the country, around $230/week); 

  • Extends unemployment insurance coverage by 13 weeks;

  • Provides (federally funded) unemployment benefits to people that lose their jobs but are ineligible for the state’s regular unemployment insurance program;

  • Provides cash payments of $1,200 per adult ($2,400 for a married couple) and $500 per dependent child age 16 or younger. The rebates phase down gradually for couples with incomes above $150,000 and individuals above $75,000 (and the benefits are limited to people that file tax returns);

  • Give states money (a $150B Coronavirus Relief Fund) that they can draw down for virus-related costs; and

  • $30B for schools and colleges and universities and $3.5 billion for child care.

Of course, there’s a lot more to it. A good summary is in this Center on Budget and Policy Priorities site. Thanks to AzPHA member Lauraine Hanson for finding this good summary resource so fast.

“Everyone is a Keynesian in a Foxhole”

        – University of Chicago’s Robert Lucas, 2009