Healthcare Provider COVID-19 Info
HHS announced approximately $3 billion in funding to safety net hospitals and approximately $1 billion to specialty rural hospitals, urban hospitals with certain Medicare designations, and hospitals in small metropolitan areas. HHS is also opening the provider portal to allow dentists to apply to relief. (Here)
Updates From FEMA
Working with HHS, FEMA is leading the federal response for operations for the Vice President’s Task Force. FEMA is requesting that entities requiring supplies including PPE first seek additional supplies through commercial channels. If supplies are not available, entities should work through their State Emergency Operations Centers (EOCs), as they would in any FEMA response effort. Requests for assistance from local entities must go through the state for fulfillment. Through the state EOCs and FEMA Regional Offices, FEMA is receiving requests for masks, swabs, test site supports, ventilators, and more. Providers, such as hospitals, should contact local and state officials for assistance. Entities including health care providers can also call the FDA’s hotline if they are having shortages of PPE (1-888-INFO-FDA) and then choose option (*).
FEMA compiled the best practices and lessons learned that communities have already faced fighting COVID-19. FEMA will continue to add content and highlight key areas where communities can benefit from learning. To learn more about Coronavirus Emergency Management Best Practices, click here.
Updates from the FDA
FDA published information on how the study of antibody response to SARS-CoV-2 spike proteins could help inform vaccine design. FDA scientists have identified specific areas on the spike protein of SARS-CoV-2 that appear to be key to triggering protective antibody responses in rabbits. These insights into the immune responses to specific areas of the spike protein could help scientists predict and evaluate whether vaccines under development will offer clinical benefit. (Here)
Laboratories, providers, manufacturers, and developers that are having difficulties obtaining COVID-19 tests or supplies for COVID-19 testing, including swabs, media needed for transport, and conservation of the samples, please call the FDA’s hotline (1-888-INFO-FDA). The FDA hotline can also help laboratories or other entities determine which tests best match their laboratory capabilities; the entity should do a survey of available laboratory equipment before calling. Labs that have questions regarding diagnostic development, including how to submit Pre-EUA/EUA submissions to FDA should email CDRH-EUA-Templates@fda.hhs.gov or call the Division of Microbiology Devices at (301) 348-1778.
FDA has generated FAQs in response to questions from labs, manufacturers, health care providers, and others. These FAQs are updated regularly and can be accessed here.
FDA released guidance with recommendations to help facilitate the timely development of safe and effective vaccines to prevent COVID-19. The guidance provides an overview of key considerations to satisfy requirements for chemistry, manufacturing and control, nonclinical and clinical data through development and licensure, and for post-licensure safety evaluation. Importantly, given the current understanding of SARS-CoV-2 immunology, the goal of development programs at this time should be to support traditional FDA approval by conducting studies to directly evaluate the ability of the vaccine to protect humans from SARS-CoV-2 infection and/or disease. (Here; guidance available here)
Updates from NIH, HHS and CMS
NIH released a COVID-19 Strategy Plan, a framework for accelerating the development of therapeutic interventions, vaccines, and diagnostics for SARS-CoV-2. NIH will implement five cross-cutting strategies: (1) invest in NIH and NIH-funded researchers to increase fundamental and foundational knowledge of SARS-CoV-2 and COVID-19; (2) speed innovation in COVID-19 testing technologies through NIH’s RADx initiative which aims to deliver rapid, widely accessible testing strategies to the public; (3) participate in public-private partnerships such as NIH’s ACTIV partnership and federal partnerships such as Operation Warp Speed to speed identification, development, evaluation, and manufacturing of promising candidate therapeutics and vaccines; (4) support studies on preventative treatments and behavioral and community prevention practices to identify and implement effective approaches for promoting individual and community safety; and (5) ensure that diagnosis, treatment, and prevention options are accessible and available for underserved and vulnerable populations at greatest risk. (Here)
HHS distributed an additional 1,623 cases of remdesivir. This is the first distribution of commercially available remdesivir. There are 40 vials per case and the average patient receives 6.25 vials over a five-day course of treatment. Hospitals receiving the product within a state are determined by the state department of health and distributed by AmerisourceBergen. (Here; distribution table by state here)
CMS announced that it plans to deploy Quality Improvement Organizations (QIOs) across the country to provide immediate assistance to nursing homes in the hotspot areas as identified by the White House Coronavirus Task Force. QIOs are CMS contractors who work with health care providers to help them improve the quality of health care they provide to Medicare beneficiaries. In addition, the agency is implementing an enhanced survey process tailored to meet the specific concerns of hotspot areas and will coordinate federal, state, and local efforts to leverage all available resources to these facilities. (Here)