December 16 2020 – Bipartisan group of lawmakers release COVID-19 relief legislation. A bipartisan group of senators and representatives yesterday released legislative text for both the Emergency Coronavirus Relief Act of 2020, a $748 billion COVID-19 relief package that boosts funding for health care providers, vaccines and testing, and the Bipartisan State and Local Support and Small Business Protections Act that provides $160 billion in state and local aid, as well as certain liability protections for employers, which extend to health care providers in some instances.
The main package would include $35 billion in additional funding for the Provider Relief Fund and make changes to the PRF reporting guidelines. Specifically, as urged by the AHA, the package would require the Department of Health and Human Services to revert back to its June reporting requirement guidance insofar as it allowed providers to use any reasonable method to calculate lost revenue. In addition, the package would allow health systems to move targeted PRF distributions within their system.
It is not clear what Senate and House leadership will do with the legislation, although it may provide the framework for COVID-19 relief that could be included as part of an omnibus government funding bill that could be taken up as early as this week.
FDA verifies safety, efficacy data for Moderna COVID-19 vaccine candidate. Ahead of a Dec. 17 meeting of its Vaccines and Related Biological Products Advisory Committee, the Food and Drug Administration released a briefing document confirming Moderna’s data on the safety and efficacy of the mRNA-1273 COVID-19 vaccine candidate. FDA said mRNA-1273 is 94.1% effective in preventing severe COVID-19, with "no specific safety concerns identified that would preclude issuance of an (emergency use authorization)." Like the Pfizer vaccine approved last week, the Moderna candidate requires two doses, albeit 28 days apart, compared with Pfizer’s 21. Once approved for emergency use, Moderna is expected to supply 200 million vaccine doses to the U.S. through the end of 2021.
AHA, AMA, ANA thank health care professionals and urge them to share experiences with COVID-19 vaccine. In an open letter today, the AHA, American Medical Association and American Nurses Association thanked health care professionals for their dedication and sacrifices this year and urged them to continue their battle against COVID-19 by taking a vaccine and sharing their experience with others. “As frontline caregivers, our essential role in protecting the health and wellbeing of our communities goes beyond the care we provide,” the letter notes. “As a valued and trusted voice, our example is perhaps the strongest health resource we have.”
FDA authorizes first over-the-counter fully at-home COVID-19 test. The Food and Drug Administration today issued an emergency use authorization for the first over-the-counter fully at-home diagnostic test for COVID-19. The antigen test for persons age 2 and older can detect the SARS-CoV-2 virus in a nasal swab sample in about 20 minutes. The new Ellume COVID-19 Home Test is less sensitive and specific than typical molecular tests run in a lab, but “the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health.
