The following is the latest COVID-19 information from the federal government as 2:30 p.m. on Monday, September 29.
Provider Relief Fund
- HHS has revised its Provider Relief Fund FAQ with updated information about the tax identification number (TIN) validation process for phase 2 general distribution payments. The update consists of six changes, all marked “modified 9/28/2020,” on pages 30 and 31 of that document.
Department of Health and Human Services
HHS announced that it will distribute 150 million units of a rapid point-of-care COVID-19 diagnostic test to states with the expectation that they will be used to facilitate the reopening of schools, critical infrastructure, and businesses and to support first responders.- HHS’s Assistant Secretary for Preparedness and Response, has posted the presentation “COVID-19: Optimizing Healthcare Personal Protective Equipment and Supplies,” which was the centerpiece of a recent webinar. Go here to see the presentation and find information about how to view the recorded webinar.
HHS Centers for Medicare & Medicaid Services
- CMS has updated its FAQ on Medicare fee-for-service billing services with a list of NCDs/LCDs whose clinical indications will not be enforced during the COVID-19 emergency. That question can be found on page 116 and is marked “Updated: 9/24/20.”
- CMS has released new tools to facilitate the process for laboratories to gain Clinical Laboratory Improvement Amendments (CLIA) certification to test for COVID-19. See CMS’s announcement about the new tools, a new “quick-start guide,” and CMS’s updated web page on applying for CLIA certification.
Food and Drug Administration
- The FDA has issued emergency use authorization (EUA) for the first serology (antibody) point-of-care test for COVID-19.
- The FDA has issued an EUA for a negative pressure clear tent enclosure that is attached to hospital beds and contains four pairs of sleeves with attached gloves to allow for access to isolated patients to be used as a supplement to personal protective equipment when treating patients with COVID-19. Go here to see the FDA’s letter issuing the EUA and also see a fact sheet for providers and instructions for health care personnel on the product’s use.
- The FDA has posted a document summarizing updated evidence to support the emergency use of COVID-19 convalescent plasma.
- The FDA will host a virtual Town Hall on Wednesday, September 30 for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for COVID-19. Go here for further information about participating in the event.
The FDA has posted a Centers for Disease Control and Prevention
- The CDC has published a report on the changing age distribution of COVID-19 patients between May to August.
- The CDC has posted guidance to health care providers on assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biologic products for COVID-19 prevention and treatment.
