|March 27, 2020
Congress passed and the President signed the CARES Act, a $2 trillion relief package that provides much needed economic relief for American families and businesses who are hurting through no fault of their own. This legislation will provide assistance to America’s heroic healthcare workers who are on the frontlines of this outbreak, including $100 billion which will go to healthcare providers, including hospitals on the front lines of the COVID-19 pandemic, $27 billion which will go to bolstering life-saving capabilities, including developing vaccines and the development, purchase, and distribution of critical supplies and $45 billion which will go to the Federal Emergency Management Agency Disaster Relief Fund, more than doubling the amount available to support the President’s Emergency and Disaster Declarations to empower State, local, and tribal leaders to effectively respond.
See below for updates on today’s releases:
Continued Efforts to Expedite Testing: Initially, nasopharyngeal swab were the only recommended swabs to be used for diagnostic testing of COVID-19. Subsequently, FDA identified a number of other swabs that were available to collect samples. Now, FDA has newly released information that recommends for symptomatic patients, nasal swabs could be used that access just the front of the nose rather than the depth of the nasal cavity. This would provide COVID-19 testing that is more comfortable for patients, allows self-collection of samples at collection sites, and that can be performed with a simpler and more readily available swab.
Expansion of Diagnostics to Test for COVID-19: During the COVID-19 pandemic, the FDA has worked with more than 220 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 17 emergency use authorizations have been issued for diagnostic tests, including the AvellinoCoV2 test, which is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. Additionally, FDA has been notified that more than 100 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
Expanding Face Masks for General Use and Conserving N95 for Health Care Workers: FDA issued an immediately in effect guidance on an Enforcement Policy for Face Masks and Respirators During the COVID-19 Public Health Emergency. The FDA believes the policy set forth in this guidance may help address urgent public health concerns by helping to expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals.
Repurposing Ventilators: FDA has issued guidance allowing ventilators from outpatient surgical centers and clinics to be modified by changing a vent. This policy will assist states with being able to identify a whole new range of ventilators that could be easily converted, add to their supply, and focused at the point of the need in their states. Anesthesiologists Patient Safety Foundation (APSF)/American Society of Anesthesiologists (ASA) has issued guidance on purposing anesthesia machines as ICU ventilators.
Maintaining Essential Health Services During an Outbreak: The WHO released Operational Guidance for Maintaining Essential Health Services During an Outbreak. This document provides guidance on a set of targeted immediate actions that countries should consider at national, regional, and local level to reorganize and maintain access to high-quality essential health services for all.
Public-Private Partnership to Develop a New Screening Tool: In partnership with the White House Coronavirus Task Force, the Department of Health and Human Services, and the Centers for Disease Control and Prevention (CDC), Apple released an app and website that guides Americans through a series of questions about their health and exposure to determine if they should seek care for COVID-19 symptoms. The screening tool provides CDC recommendations on next steps including guidance on social distancing and self-isolating, how to closely monitor symptoms, recommendations on testing, and when to contact a medical provider.
Extending the Supply of and Providing Consumer Information on Hand Sanitizer: FDA issued guidance for the temporary manufacture of ethanol products by firms that manufacture alcohol for incorporation into alcohol-based hand sanitizer products. The FDA posted questions and answers related to consumer use of hand sanitizer during the COVID-19 public health emergency. The FDA wants to make consumers aware of the steps the agency is taking to increase the supply of hand sanitizer during this public health emergency. The questions also discuss hand washing, expiration dates and other frequently asked questions by consumers on hand sanitizer.
Avoid All Non-Essential International Travel: CDC issued a travel warning today for all individuals to avoid all non-essential international travel in an effort to curb the ongoing transmission of COVID-19.
CMS Continuing to Provide State Flexibilities: CMS has now approved 34 Section 1135 Medicaid waivers in states. CMS also approved 8 state requests to invoke emergency flexibilities in their programs that care for the elderly and people w/ disabilities in their homes & communities.
Providing Telehealth Resources for Long-Term Care and Nursing Home Facilities: CMS has broadened access to Medicare telehealth services so that beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility. This toolkit will aid and provide information to facilities utilizing the new telehealth flexibilities.
HRSA Gives Flexibilities to Grantees: HRSA has adopted all 13 administrative flexibilities outlined as available by OMB and has released an FAQ on these flexibilities for grantees.
Flexibility Regarding Nutrition Labeling: The FDA issued guidance on a Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency. The FDA is issuing this guidance to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they can sell certain packaged foods during the COVID-19 pandemic. For example, restaurants may have purchased ingredients that they can no longer use to prepare restaurant food and instead wish to sell to their customers.