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

Congress

• Congress is making progress toward 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 stated he will support the relief bill if an agreement is reached.

White House and Federal Agencies

• The Government Accountability Office (GAO) published a detailed report on how the federal government can improve its COVID-19 response. The findings include:
  • States and territories were concerned about 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 made 11 recommendations for how the government can improve its response to the pandemic.
• The Centers for Medicare and Medicaid Services (CMS) updated COVID-19 Frequently Asked Questions on Medicare Fee-for-Service Billing for 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 CMS notes that in many instances, the general statements of the FAQs referenced have been superseded by COVID-19-specific legislation, emergency rules, and waivers granted under section 1135 of the Act, specifically to address the COVID-19 public health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 The policies set out in this FAQ are effective for the duration of the PHE unless superseded by future legislation.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 Biden announced that 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 is extending the 2020 Merit-based Incentive Payment System (MIPS) Extreme and Uncontrollable Circumstances Exception application deadline to February 1, 2021.
• HHS created a new online portal where 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 a vast 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 revised guidelines that 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 to protect yourself and others from COVID-19 when performing daily activities and going out.
  • for older 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
    • for people 18-24 to help them navigate the COVID-19 pandemic.

• recommendations for travel-associated exposures.
• CDC has been rapidly onboarding healthcare 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 is optimistic that both Pfizer and Moderna’s vaccines will receive FDA approval before the end of the month.
• The United Kingdom approved Pfizer’s vaccine.
  • NIAID Director Dr. Anthony Fauci criticized how quickly the U.K. approved the vaccine.
• The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17 to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Moderna Inc. This will follow the December 10 VRBAC meeting to review the Pfizer vaccine.
  • Deliveries of Pfizer’s COVID-19 vaccine could begin as early as December 15 with FDA approval expected in the next few weeks.
  • The White House hopes to vaccinate 100 million people by the end of February.
• The CDC’s Advisory Committee on Immunization Practices (ACIP) finalized its recommendations for 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 will begin clinical trials of 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 the allocation dashboard.
• The Department of Transportation announced all of its necessary regulatory measures have been taken for the safe, rapid transportation of the COVID-19 vaccine by 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 a video interview.
• Dr. Stephan Hahn was on Instagram Live with ABC News discussing the process of reviewing vaccines. You can view the interview here.
• HHS and DoD senior officials held a briefing on Operation Warp Speed and COVID-19 vaccines.