COVID-19 Federal Responses: Thursday, December 3, 2020

Congress

• Congress is makingprogresstoward agreeing on new $908 billion bipartisan COVID-19 relief legislation. Congress is also making progress on legislation to extend federal funding before funding expires on December 11. It is possible that COVID-19 relief is coupled with a government funding bill.President Trump statedhe will support the relief bill if an agreement is reached.

White House and Federal Agencies

• The Government Accountability Office (GAO) published a detailedreport联邦政府如何改善其COVID-19 response. The findings include:
  • 国家和地区关注ongoing shortages of some testing-related and other medical supplies.
  • As vaccines and therapeutics are approved for use, more transparency around the Food and Drug Administration’s (FDA’s) scientific reviews of safety and effectiveness is needed to strengthen public confidence in them.
  • The Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) have provided little scientific explanation for changing key testing guidelines during the pandemic.
  • GAO made11 recommendationsfor how the government can improve its response to the pandemic.
• The Centers for Medicare and Medicaid Services (CMS) updatedCOVID-19 Frequently Asked Questions on Medicare Fee-for-Service Billingfor Medicare providers. This updated FAQ also covers Medicare telehealth. CMS notes that in many instances, the general statements of the FAQs referenced have been superseded by COVID-19-specific legislation, emergency rules, and waivers granted under section 1135 of the Act, specifically to address the COVID-19 public health emergency (PHE). The policies set out in this FAQ are effective for the duration of the PHE unless superseded by future legislation.
• President-elect Joe Bidenannouncedthat former Surgeon General Vivek Murthy will reprise this role in the new administration. Murthy, along with Jeff Zients, will lead the COVID-19 response for the new administration.
• CMS isextendingthe 2020 Merit-based Incentive Payment System (MIPS) Extreme and Uncontrollable Circumstances Exception application deadline to February 1, 2021.
• HHS created a new onlineportalwhere people can volunteer for clinical trials and convalescent plasma donations.
• NIH Director Dr. Francis Collins released a blog post on a study that finds that avast majority of pregnant women with COVID-19 won’t have complications.
• CMS announced its December Virtual Office Hours:
  • Tuesday, December 8th at 5:00 – 6:00 PM Eastern

Toll Free Attendee Dial In: 833-614-0820;

Access Passcode: 3129517

Audio Webcast link:https://engage.vevent.com/rt/cms2/index.jsp?seid=2766

• Tuesday, December 22nd at 5:00 – 6:00 PM Eastern

Toll Free Attendee Dial In: 833-614-0820;

Access Passcode: 3968359

Audio Webcast link:https://engage.vevent.com/rt/cms2/index.jsp?seid=2771

Centers for Disease Control and Prevention (CDC) Updates

• The CDC issued revisedguidelinesthat reduce the recommended quarantine period for COVID-19 from 14 days to 7-10 days. The CDC believes the shorter quarantine period will increase compliance.
• CDC updated information:

• • on how toprotect yourself and othersfrom COVID-19 when performingdaily activities and going out.
  • forolder adults,who are at greater risk of requiring hospitalization or dying if diagnosed with COVID-19.
  • their toolkit for

• • • childcare programs,
    • summer camps,
    • people 15 to 17, and
    • forpeople 18-24to help them navigate the COVID-19 pandemic.

• recommendations fortravel-associated exposures.
• CDC has been rapidlyonboardinghealthcare facilities to electronic case reporting (eCR) during the COVID-19 pandemic. As of November 23, 2020, more than 6,300 facilities are sending COVID-19 electronic initial case reports to public health using eCR.

Economy, Vaccine, Testing and Treatment

• HHS Secretary Alex Azar isoptimisticthat both Pfizer and Moderna’s vaccines will receive FDA approval before the end of the month.
• The United KingdomapprovedPfizer’s vaccine.
  • NIAID Director Dr. Anthony Faucicriticizedhow quickly the U.K. approved the vaccine.
• The FDA hasscheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc. This will follow theDecember 10 VRBAC meeting to review the Pfizer vaccine.
  • Deliveries of Pfizer’s COVID-19 vaccinecould beginas early as December 15 with FDA approval expected in the next few weeks.
  • The White House hopes to vaccinate100 million peopleby the end of February.
• The CDC’s Advisory Committee on Immunization Practices (ACIP)finalized its recommendationsfor how to prioritize COVID-19 vaccine distributions. The recommendations are non-binding but highly influential. ACIP recommends that frontline healthcare workers and nursing home residents should be the top priorities to receive vaccines.
• Moderna announced it willbegin clinical trialsof its vaccine in adolescents. Children will not be approved for vaccination until a clinical trial is completed.
• HHS and Department of Defense (DoD) announced the purchase of 650,000 additional treatments courses of Eli Lilly and Company’s antibody therapeutic, bamlanivimab, to be delivered in December and January for treatment of non-hospitalized COVID-19 patients. This latest purchase brings the total to 950,000 treatment courses. To find out how much bamlanivimab has been allocated to specific states, territories, and jurisdictions, visit theallocation dashboard.
• The Department of Transportation announced all of its necessary regulatory measures have been taken for thesafe, rapid transportation of the COVID-19 vaccineby land and air.
• Operation Warp Speed’s Deputy Lead for Therapeutics Col. Deydre Teyhen discusses the types of treatments, ongoing research and the continued importance of ongoing research to treat COVID-19 in avideo interview.
• Dr. Stephan Hahn was on Instagram Live with ABC News discussing the process of reviewing vaccines.You can view the interviewhere.
• HHS and DoD senior officialsheld a briefingon Operation Warp Speed and COVID-19 vaccines.