Issue #10| March 30, 2020
Your COVID-19 news & updates


We will continue to bring you updates on COVID-19 as we are provided with new information. If you receive new information, or if you would like to share info about how your practice is responding, please feel free to share it with us by emailing ldearing@azafp.org. Thank you!
AZ Policy Update
by: Peters, Cannata & Moody plc                         
Today Governor Ducey announced new guidance for Arizonans to stay at home – guidance that state public health officials believe is needed to help stop the increase of COVID-19.   The executive order  stops short of some of the strict stay-at-home measures that have been implemented in other states but issues stronger standards for physical distance. It becomes effective at 5:00 p.m. on Tuesday. The Governor emphasized that the order will not close grocery stores or pharmacies, and urged Arizonans to continue to enjoy outdoor exercise and virtual connections to each other while practicing recommended physical distancing.
 
This morning, Governor Ducey also joined with Superintendent of Public Instruction Kathy Hoffman to announce that  Arizona schools will be closed  for the rest of the school year due to the ongoing threat of COVID-19. The State Board of Education  meets tomorrow  to implement guidance for schools that have transitioned to online programs for students.
 
The Governor also:
  • Began distributing the $50 million COVID-19 aid package the legislature passed last week, providing $6.7 million for food banks, nutrition programs, and programs that serve individuals experiencing homelessness.
  • Announced that banks are suspending foreclosures and evictions, and implementing a small business loan program for Arizona businesses.
 
The Attorney General, in response to a question from a  state legislator , provided guidance on  how much patient information  can be shared while the state combats COVID-19.
 
The Secretary of State  continued her call  for the legislature to reconvene to authorize county elections officials to implement an all-mail election this year. So far, the Governor and legislative leaders have not shown interest in complying with the request. Voters can already choose to vote by mail, however:  click here  to learn how to request your ballot.
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Coronavirus Update: FDA expedites review of diagnostic tests to combat COVID-19
This statement is attributed to: FDA Commissioner Stephen M. Hahn, M.D.

The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed. Moreover, as in previous emergencies, the FDA has been extremely proactive and supportive of test development by all comers—laboratories, and large and small commercial manufacturers—offering our expertise and support to speed development and to quickly authorize tests that the science supports.


Developing a test:

-        Typically, with an emerging health threat, the Centers for Disease Control and Prevention (CDC) is the first developer of a diagnostic test.
-        Samples of the virus are crucial to confirming the accuracy of the test.
-        CDC has first access to viral samples that other test developers do not. CDC also manufactures their own tests for distribution to their national network of public health labs. In this pandemic, CDC encountered problems manufacturing their test. FDA assisted CDC in their work to resolve the issue and utilize a commercial manufacturer to make tests for any laboratory, not only public health labs.
-        Viral samples became commercially available to private sector test developers in later February, when the National Institutes of Health’s partner  BEI Resources  began selling vials of the virus grown from material provided by CDC.
-        Laboratories have always had the ability to develop their own tests in the U.S.; the COVID-19 outbreak did not change this. Once a developer has a viral sample, they can confirm the accuracy of their test very quickly, usually in two to three days.
-        In the future, making viral samples available earlier to commercial developers will be crucial to deploying tests quickly. Moreover, CDC’s test should be manufactured by a commercial entity with the requisite expertise. 

Timeline of FDA support for test developers:
-        Since the beginning of January, the FDA has worked with more than 230 test developers who have or are expected to submit requests for FDA emergency authorization of their tests; to date, 20 authorizations have been granted.  
-        In addition, more than 110 laboratories have notified the FDA that they have begun using their own tests. 
-        For interested developers, the FDA provided recommendations for how to check a test for accuracy as well as a short form to make it easy to share their test information quickly in support of an Emergency Use Authorization (EUA).   

Emergency Use Authorization authorities:
-        An EUA, put into place by Congress, is a relaxed standard that allows tests to be made available based on less data than in non-urgent circumstances and allows for expedited FDA review.   
-        EUA authority is not a barrier to test availability.
-        For diagnostics, EUA still requires an accurate test, but allows the FDA to quickly review, in as little as a day, which it has done repeatedly.
FDA policy updates:
-        The FDA recognized the urgent need for even faster testing availability. Although laboratories could use the EUA pathway, many were hesitant or didn’t know the pathway was available to them. 
-        To respond to this need, the FDA revised the process to allow labs to begin testing prior to FDA review of their validation data. This policy change was an unprecedented action to expand access to testing. Nevertheless, in the first week, only six laboratories took advantage of this further streamlined process because many laboratories did not have a test, or did not have the viral samples to check the accuracy of their test. 
-        In addition, the FDA implemented another change to empower states to take responsibility for tests developed and used by laboratories in their states without FDA review. 
The FDA has and will continue to play a pivotal role in this emergency response. Our doors will continue to remain open.
① MCDPH Alert:  New Resources and Updated Testing Criteria COVID-19 (Below)
②  ADHS Health Alert:  Updated Testing, Contingency PPE & Crises Measures COVID-19 (Below and attached)
③ CDC Health Advisory: Severe Illness Associated with Non Pharmaceutical Use of Chloroquine 
 
Frequently review changing Healthcare Provider recommendations:
§   Arizona Department of Health Services  ǀ 844.542.8201
§   Pima County Health Department  ǀ 844.542.6767
Dr. Bob England  Daily Video updates
Webinars for Healthcare Professionals ( Register for the webinars every Tuesday )
Clinician Outreach and Communication Activity ( Clinical Guidance Webinars )
① MCDPH: New Resources and Updated Testing COVID-19
From: pubhr-surv (PHS) [mailto:pubhr-surv@maricopa.gov] 
Subject: SURV Alert: COVID-19 Testing Criteria Update and Resources

Dear Maricopa County Healthcare Providers,
Thank you for your continued hard work and dedication to caring for Arizonans during this unprecedented time. Your commitment to patient care in the midst of this pandemic is critical, and Public Health is here to support you. I want to share with you updated statewide criteria for COVID-19 testing at the Arizona State Public Health Laboratory and several additional resources, including:
·       Maricopa County Long-Term Care Facility Guidance
·       CDC Strategies to Optimize the Supply of PPE and Equipment
·       Enforcement Discretion of HIPAA for Telehealth During COVID-19
·       AHCCCS FAQs about COVID-19
1)     Updated – Statewide Criteria for COVID-19 Testing at the Arizona State Public Health Laboratory
·       Fever AND respiratory symptoms without requiring hospitalization – criteria expanded to include people with a critical/high-risk infrastructure occupation or who lives in a congregate setting
·       Fever AND severe acute lower respiratory illness – criteria clarified to define radiographic confirmation of pneumonia of unknown etiology
2)     Updated – Maricopa County Long-Term Care Facility Guidance (attached)
·       Expanded guidance for prevention of the introduction and transmission of COVID-19 in facilities
·       New guidance about what to do if a resident is diagnosed with COVID-19 in your facility
·       Updated CDC guidance for optimization of:
Facemasks
·       HHS guidance about allowing the use of popular applications (FaceTime, Facebook Messenger, Google Hangouts, etc.) to increase access to telehealth services withoutimposing penalties under HIPAA
·       Answers to questions about billing and coding during COVID-19, including pharmaceuticals, supplies, and telehealth services


Thank you again for all that you do. MCDPH hosts regular COVID-19 webinars on Tuesdays at 11AM for healthcare providers, including Q&A. If you would like to participate, please register here .
 
Stay healthy,
Rebecca
    
Rebecca Sunenshine, MD, FIDSA
CAPT, US Public Health Service
CDC Career Epidemiology Field Officer
Medical Director, Disease Control
4041 N. Central Ave., Suite 600 | Phoenix, AZ 85012

Check out ALL of the AzAFP's COVID-19 updates here on our website: AzAFP COVID-19 Resources Page