Coronavirus Disease (COVID-19) Update

HBMA COVID-19 Federal Response Update

Congress

• Democrat and Republican leaders in the Senate intend to resume negotiations on bipartisan COVID-19 relief legislation.

White House and Federal Agencies

• Vice President Mike Pence led a discussion with the chief executives and senior leaders of approximately 50 states, territories, and the city of Washington, DC, and the White House Coronavirus Task Force to discuss local, state, and federal COVID-19 response and recovery efforts including the continued collaboration on vaccine distribution and administration planning. You can view the full readout here.
• CMS is publicly recognizing the 1,092 nursing homes at which 50% or more of their staff have completed CMS training designed to help staff combat the spread of COVID-19 in nursing homes.

Centers for Disease Control and Prevention (CDC) Updates

• The CDC published updated guidance for small gatherings such as Thanksgiving dinners.
• CDC updated FAQs for healthcare workers on clinical questions they might have about COVID-19.
• CDC updated current guidance on community exposure for people exposed to people with known or suspected COVID-19.
• Take steps to care for yourself and help protect others in your home and community.
• CDC updated information for college and universities to plan, prepare, and respond to COVID-19 while reopening.
• CDC updated FAQs for laboratories on COVID-19.
• CDC updated information on COVID-19 for where you live, work, learn, and play in your community, work, and school.
• CDC updated information for schools and child care to plan, prepare, and respond to COVID-19 as they reopen. CDC also updated information on monitoring and evaluation mitigation strategies in child care programs.
• This document provides guidance for administrators, staff, and nurses in K-12 schools on COVID-19 symptom screening for schools opening for in-person learning. 
• CDC updated guidance for pharmacists and pharmacy technicians in community pharmacies during the COVID-19 response.

Economy, Vaccine, Testing and Treatment

• The U.S. has reported at least 100,000 new COVID-19 cases for 15 consecutive days.
• HHS Secretary Alex Azar believes the U.S. will be able to distribute 40 million vaccines before the end of the year.
• The FDA issued its first Emergency Use Authorization (EUA) for COVID-19 test where the person can collect their own sample at home.
• FDA Commissioner Dr. Stephen Hahn released a statement on the FDA’s ongoing commitment to transparency for COVID-19 EUAs.
• The FDA published a new webpage, A Closer Look at COVID-19 Diagnostic Testing, to provide health care providers and other public health professionals, including those who might purchase COVID-19 tests, more technical information and resources. language information about both diagnostic and antibody testing for COVID-19.
• AstraZeneca is reporting positive preliminary data for its COVID-19 vaccine candidate. It is on track to release more detailed data by Christmas.
• Johnson & Johnson is on track to submit data on its COVID-19 vaccine candidate to the FDA in February.
• Operation Warp Speed (OWS) posted clips from an interview with Dr. Moncef Slaoui who discusses several aspects of vaccine development and the accelerated process to find a safe and effective COVID-19 vaccine. OWS says every state will have vaccine doses within 24 hours of FDA approval.
• Hospitals are beginning to cancel elective procedures again as COVID-19 cases continue to rise across the country.
• Pfizer released more details on the safety and efficacy data for its vaccine candidate. Pfizer is preparing to submit this data to the FDA for approval. The FDA is cautioning that the review will take several weeks.
• Pfizer will pilot distribution of its COVID-19 vaccine in four states to test out how it will handle the logistical challenges associated with its vaccine such as the requirement for ultra-cold storage. The four pilot states are Rhode Island, Texas, New Mexico, and Tennessee.
• FDA updated its guidance on investigational COVID-19 convalescent plasma. The updated guidance extends the period of enforcement discretion through the end of February 2021. This extension will allow continued access to convalescent plasma for the treatment of hospitalized COVID-19 patients while blood establishments develop the necessary operating procedures to manufacture the plasma consistent with the EUA.
• The FDA has reorganized the FAQs on Testing for SARS-CoV-2 webpage to make it easier to navigate to questions by topic. The agency also updated the answers to certain questions in the following sections:
• FDA Commissioner Dr. Stephen Hahn answers questions about the phases of clinical trials in this video. You can also sign up to be a volunteer in a COVID-19 clinical trial at www.coronaviruspreventionnetwork.org.
• According to the American Academy of Pediatrics and the Children’s Hospital Association, over 1 million children have been diagnosed with COVID-19.
• Federal Reserve Chair Jerome Powell says economic relief measures will still be needed after vaccines become available.