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COVID-19 Update | August 11, 2020
Technical Guidance, Standards and Resources
Clinical Care and Treatment
 
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Testing and Cases
 
 
 

Incident Management
 
 
Payment and Reimbursement Policy
Research and Resources Development Funding Opportunities
NIH-funded project seeks to identify children at risk for MIS-C
The opportunity seeks to support innovative research to develop novel or unique approaches to identify and characterize the spectrum of COVID-19 related illnesses, including MIS-C, in children, and predict the longitudinal risk of disease severity after COVID-19 exposure. Applications Due Sept. 30
Information for Patients, Visitors and the General Public
Event Announcements
COVID-19 and Mental Health: Spatial Distancing, not Social Distancing (American Lung Association)
Wed., Aug. 12, 3 - 4 p.m. CT
REGISTER
The limiting of face-to-face contact with others has helped reduce the spread of the novel coronavirus that causes COVID-19. Yet the physical distancing required to keep the virus at bay may invite unwanted emotions such as loneliness, anxiety and feelings of helplessness. Join us as top experts review coping strategies and techniques to manage your mental health while maintaining your physical health.
Speakers: Dr. Tyish Hall Brown, Ken Duckworth, MD, Jolene (JOJO) O’Neal, Albert Rizzo, M.D., FAC
Trade Press, Journal Articles, White Papers
ICHE Coronavirus and COVID-19 Article Collection 
The editors of ICHE have created a page for on the ICHE web site for COVID-19 related articles, commentaries, and letters to the editor. All COVID-19 manuscripts in their accepted form are freely available here. Check back frequently for updates.
 
Low-Cost Measurement of Facemask Efficacy for Filtering Expelled Droplets during Speech. Fischer, Emma P., et al. Science Advances, American Association for the Advancement of Science, 7 Aug. 2020. DOI: 10.1126/sciadv.abd3083 
  
Clinical Course and Molecular Viral Shedding Among Asymptomatic and Symptomatic Patients With SARS-CoV-2 Infection in a Community Treatment Center in the Republic of Korea. Lee S, Kim T, Lee E, et al.  JAMA Intern Med. Published online August 06, 2020. doi:10.1001/jamainternmed.2020.3862 
News Highlights
Federal Policy Updates

W&M Chair Neal Urges CMS to Improve Reliability of COVID-19 Nursing Home Data

House Ways and Means (W&M) Committee Chairman Richard Neal (D-MA) called on Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma to improve the reliability of both staff and patient COVID-19 nursing home data.

 

As noted in Table 1 at the end of the letter, 12.4 percent of the Nursing Home COVID19 Public File data fields were missing (as of July 24, 2020). Chairman Neal notes that the Department of Health and Human Services (HHS) announced on July 22 that $4.9 billion of the Provider Relief Fund would be allocated to skilled nursing facilities but has not yet announced the methodology that will be used to distribute these funds. He further states: “Given the lack of reliability of both staff and patient COVID-19 nursing home data CMS has publicly reported, I am deeply concerned that the decisions related to the allocation of these funds may be informed by incomprehensive and unreliable data.”

 

Chairman Neal requests Administrator Verma to respond to a series of questions by August 21 regarding:

  • How CMS will use data to inform resource allocation;
  • What guidance CMS has provided to nursing homes regarding PPE shortages;
  • How CMS is ensuring facilities are reporting COVID-19 information to the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network; and
  • How CMS is training surveyors on the May 6th guidance titled, “Interim Final Rule Updating Requirements for Notification of Confirmed and Suspected COVID-19 Cases Among Residents and Staff in Nursing Homes.”
     

President Trump Signs 'Buy American' Executive Order Directing Federal Agencies to Procure US-Made Essential Medicines, Countermeasures, Critical Inputs

Late today, President Trump signed an Executive Order directing federal agencies to undertake a variety of approaches to increase their procurement of yet-to-be-specified “essential medicines, medical countermeasures, and critical inputs” that are manufactured in the United States. The EO defers to the Food and Drug Administration (FDA) to identify a list of essential medicines, medical countermeasures, and critical inputs to which the stipulations apply. Critical inputs would include active pharmaceutical ingredients (APIs), API starting materials, or other drug ingredients or device components determined by the FDA to be critical to the safety and effectiveness of essential medicines and medical countermeasures.

 

Key provisions of today’s EO include:

 

Section 1. Policy – In order to be able to respond to the emergence of infectious diseases and chemical, biological, radiological, and nuclear (CBRN) threats, the EO states the U.S. must reduce its dependence on foreign manufacturers of essential medicines, medical countermeasures, and critical inputs.

 

Section 2. Maximizing Domestic Production in Procurement. The EO directs agencies to, as appropriate and in consultation with the FDA, only procure essential medicines, medical countermeasures, and critical inputs that are produced in the U.S. along with several other directives in support of this.

 

Section 3. Identifying Vulnerabilities in the Supply Chain. The EO requires that within six months, the FDA identify and take action to mitigate supply chain vulnerabilities

 

Section 4. EPA Regulatory Requirements. The EO calls on the EPA to identify requirements and guidance documents that can be revised to facilitate advanced manufacturing and expedite production of critical inputs. The EO notes this may include speeding approval of certain permits.

 

Section 5. Prioritization of Contracts for Essential Medicines, Medical Countermeasures, and Critical Inputs. Under the EO, HHS would leverage existing authority under the Defense Production Act to prioritize Federal contracts and orders for essential medicines, medical countermeasures, and critical inputs over other contracts and orders.

 

Section 6. Reporting Requirements.  Finally, the EO calls for annual reporting beginning on Dec. 15, 2021, by the heads of each applicable agency to the President on a variety of factors, including essential medicines, medical countermeasures, and critical inputs procured.

 

Agency Releases Fact Sheet on Operation Warp Speed and Describes Actions to Date

On August 7, 2020 the Department of Health and Human Services (HHS) released a fact sheet explaining Operation Warp Speed (OWS) and highlighting the actions taken to advance COVID-19 countermeasure development, manufacturing, and distribution to date.

In the fact sheet, HHS explains that OWS is a cross-agency and public-private initiative to speed development, production, and delivery of COVID-19 vaccines, therapeutics, and diagnostics. OWS involves an array of federal agencies:

  • HHS;
  • The Centers for Disease Control and Prevention (CDC);
  • The Food and Drug Administration (FDA);
  • The National Institutes of Health (NIH);
  • The Biomedical Advanced Research and Development Authority (BARDA);
  • The Department of Defense (DoD);
  • The Department of Agriculture;
  • The Department of Energy, and
  • The Department of Veterans Affairs.
     

Through OWS, these agencies are coordinating and working with private companies to advance COVID-19 countermeasure goals. HHS notes that OWS is also coordinating existing HHS-wide efforts, such as NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH’s Rapid Acceleration of Diagnostics (RADx) initiative, and work by BARDA.

 

Development

  • To streamline and expedite vaccine development, OWS is allowing steps to be taken simultaneously, such as large-scale manufacturing of a vaccine before the demonstration of efficacy and safety. HHS notes that this increases the government’s financial risk, but not the risk of the product, as vaccines must still be proven safe and effective before they can be approved or authorized and released.
  • Fourteen promising candidates have been chosen from more than 100 vaccine candidates currently in development. The 14 vaccine candidates will be narrowed down to the most promising 7 candidates. The remaining 7 candidates will go through further testing in early-stage clinical trials. Finally, the most promising candidates will enter large-scale randomized trials to demonstrate safety and efficacy.

Manufacturing

  • The federal government is facilitating investments in manufacturing capacity at its own risk. The capacity developed will be used to speed production of whichever vaccine is eventually successful, regardless of which firms developed the capacity.

Distribution

  • HHS intends to distribute vaccines and therapeutics using a tiered approach that builds on past pandemic flu methodology and is adjusted based on experience from the COVID-19 response to date, including data on:
    • The virus and its impact on populations;
    • The performance of a given countermeasure, and;
    • The needs of the essential workforce.
       
OWS is expanding domestic manufacturing and supplies of specialized materials and resources, such as glass vials, for distribution, and DoD’s involvement will support quicker distribution and administration.
SHEA Education and Events
SHEA Podcast: We’re All in this Together: COVID-19 Allies in Infection Prevention
This series focuses on the collaborative efforts and opportunities for different disciplines to address and confront the COVID-19 pandemic. Each week's episode will include discussion around what different organizations are doing to address COVID-19, what have been the biggest challenges, what changes have been made, and what opportunities there are to work together to handle the pandemic. Access the full podcast series on LearningCE.
 
SHEA Rapid Response Podcast: COVID-19 Update: What We Know Now
This series highlights changes in the COVID-19 outbreak and updates in the medical literature. Each week's episode will include a summary of important news, a brief summary of medical literature and guidelines on infection prevention that have been published related to COVID-19, and discussion around the latest and most important questions surrounding the outbreak. Access the full podcast series on LearningCE.   
  
Tune in to the latest episode: Changes in Obstetrics
SHEA Podcasts - Are we meeting the needs of our members? Please fill out the short PODCAST FEEDBACK FORM
 
  • A "Quick Implementation Guide" 7-worksheet Excel file (xls download) with self-populating worksheets to apply implementation concepts and approaches by SHEA members to individual circumstances.
  • List of guidelines and statements from other organizations for insight into stakeholders’ points-of-view. Not comprehensive; not vetted or endorsed by SHEA.  
 
SHEA Rapid Response Webinars 
ACCESS ON LEARNINGCE 
  • Healthcare Facility Outbreak Preparedness
  • SHEA COVID-19 Town Hall 1-18
  • SHEA COVID-19 Town Hall 19 | August 16 at 3:00pm ET
    REGISTER HERE
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