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Coronavirus Disease (COVID-19) Update

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12/07/2020

HBMA COVID-19 Federal Response Update

Congress

  • Congress is making progress towards 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 11th. It is possible that COVID-19 relief is coupled with a government funding bill. President Trump said 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 FDA's scientific reviews of safety and effectiveness is needed to strengthen public confidence in them.
    • HHS and 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.
  • 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 CMS notes that in many instances, the general statements of the FAQs referenced have been superseded by COVID-19-specific legislation, emergency rules, and waivers granted under section 1135 of the Act specifically to address the COVID-19 public health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 The policies set out in this FAQ are effective for the duration of the PHE unless superseded by future legislation.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 his new Administration. Murthy, along with Jeff Zients, will lead the COVID-19 response for the new Biden 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.
  • ASPR released this toolkit designed as a single source of information for hospital emergency managers and planners preparing to manage large numbers of patients during the COVID-19 pandemic. 
  • NIH Director Dr. Francis Collins released a blogpost 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:

Centers for Disease Control and Prevention (CDC) Updates

  • The CDC issued new guidelines that reduces 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.
  • CDC updated information for older adults who are at greater risk of requiring hospitalization or dying if diagnosed with COVID-19.
  • CDC updated their toolkit for childcare programs, summer camps, people 15 to 17, and for people 18-24 to help them navigate the COVID-19 pandemic.
  • CDC updated information and 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 U.S. Food and Drug Administration 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 15th 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 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 watch the conversation here.
  • HHS and DoD senior officials held a briefing on Operation Warp Speed and COVID-19 vaccines.