COVID-19 Federal Response Update – Monday, April 6, 2020

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By Capitol Associates, Inc. 

    • On Friday, President Trump announced that hospitals should not bill uninsured patients for COVID-19 treatment. He said the Department of Health and Human Services (HHS) will use some of the $100 billion it received in the CARES Act to reimburse hospitals for those costs. HHS will reimburse hospitals at the Medicare rate. HHS said it will release more details on how this process will work in the near future.
    • The Department of Labor issued new regulations on how it will implement the family leave provisions of the Families First Coronavirus Response Act. That bill expanded sick leave benefits to people who were diagnosed with COVID-19, to those who are self-quarantining as a precaution, and to parents whose children are home because their schools are closed. This regulation fills in many of the details of how the Department will implement these provisions.
    • HHS announced that the Centers for Disease Control and Prevention (CDC) will provide $186 million in assistance to state and local jurisdictions that are dealing with the most severe coronavirus situations. The funding will be used to:
      • Supplement an existing cooperative agreement to a number of states and local jurisdictions identified as having the highest number of reported COVID-19 cases (“hot zones”) and jurisdictions with accelerating or rapidly accelerating COVID-19 cases. This award will support a range of activities such as lab equipment, supplies, staffing, shipping, infection control, surge staffing, monitoring of individuals, and data management.
      • Supplement an existing cooperative agreement to state jurisdictions through the Emerging Infections Program (EIP) to enhance surveillance capabilities.
      • To view the list of CDC funding actions to jurisdictions, click here.
    • The HHS Office of Inspector General issued a report that describes the challenges hospitals faced responding to the coronavirus. The report describes a survey of hospitals conducted between March 23rd and March 27th.
      • Hospitals reported that their most significant challenges centered on testing and caring for patients with known or suspected COVID-19 and keeping staff safe. Hospitals also reported substantial challenges maintaining or expanding their facilities’ capacity to treat patients with COVID-19. Hospitals described specific challenges, mitigation strategies, and needs for assistance related to personal protective equipment (PPE), testing, staffing, supplies and durable equipment; maintaining or expanding facility capacity; and financial concerns.
    • The U.S. Naval Hospital Ship Comfort, which is currently docked in New York City, has begun treating COVID-19 patients. The Comfort originally planned to treat non-COVID-19 patients to free up capacity for the New York hospital system. However, as of this weekend, the 1,000 bed Comfort had only taken on 27 patients. New York’s Javits Convention Center was also converted into a temporary 2,500 bed hospital that is operated and staffed by the Department of Defense.
    • The U.S. Food and Drug Administration (FDA) is extending certain changes to its device approval process.
      • The FDA’s Center for Devices and Radiological health (CDRH) is extending its conversion of in-person meetings to teleconference meetings.
      • For marketing applications on hold as of March 16, 2020, where the response due date is on or before June 30, 2020, CDRH has further extended response due dates by 90 days for Premarket Notifications (510(k)s), Premarket Approval (PMA) applications (original and supplements), Humanitarian Device Exemption (HDE) applications (original and supplements) and De Novo classification requests. CDRH intends to extend this due date automatically; no extension requests are necessary to be submitted.
      • FDA has issued additional immediately in effect guidance documents related to COVID-19. For the latest information, please see the FDA’s COVID-19 Related Guidance Documents web page.
    • The Federal Reserve issued a brief statement that it will support private lenders that give out paycheck protection program loans. This could mean the Fed takes on those loans from the private lenders. The announcement is in response to concerns from some banks that the low interest rates are not enough to cover the bank’s costs for servicing the loans. According to its announcement, the Fed will issue more details later this week.

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