In response to the novel coronavirus (COVID-19) pandemic, U.S. government agencies have continued the frequent release of fact sheets and guidance documents for health care and public stakeholders. To help navigate the outpouring of information, the Wynne Health Group has maintained the attached and newly updated catalogue, intended to capture and organize the full array of relevant guidance for health care providers, insurers, state governments, public health agencies, and other stakeholders, as well as reflect the status of major actions by the White House and Congress, and pertinent funding opportunities. Within the attached document, you can follow hyperlinks to navigate to each section of the full compendium.
Reflecting a slowing of the pace at which new developments have arisen, we have been issuing the catalogue at a monthly, rather than biweekly, interval. Below, we have excerpted the pertinent developments that occurred during the month of October.
Administration for Community Living
Assistant Secretary for Preparedness and Response
- November 24: BARDA announced a partnership with Siemens Healthineers to accelerate development of the SARS-CoV-2 Antigen assay (CoV2Ag).
- November 16: BARDA announced it has expanded its partnership with DiaSorin Inc. to develop an enhanced immunoassay for determining COVID-19 patient exposure and immune status.
- November 6: BARDA and DoD announced they will provide technical assistance to Humanigen, Inc. on a Phase 3 clinical trial of a drug that is being developed to prevent or treat an immune hyper-response caused by COVID-19.
- November 6: BARDA announced it will support Mesa Biotech, Inc. in the development of a rapid combination test for influenza A/B and COVID-19.
Centers for Disease Control & Prevention
- November 17: CDC announced a pediatric immunization-focused Notice of Funding Opportunity (NOFO) – US Enhanced Surveillance Network to Assess Burden, Natural History, and Effectiveness of Vaccines to Prevent Enteric and Respiratory Viruses in Children (grants/view-opportunity.html?oppId=328354″>RFA-IP-21-002) (WHG client summary).
Centers for Medicare & Medicaid Services
Benefits and Coverage
- November 9: CMS announced that Medicare now offers coverage of bamlanivimab (a monoclonal antibody therapy) used to treat COVID-19 at no cost sharing for the duration of the public health emergency. (WHG client summary).
State-Specific Disaster Waiver Approvals
- November 25: CMS approved additional 1135 waiver flexibilities requested by Texas.
- November 5: CMS approved additional 1135 waiver flexibilities requested by Montana.
- November 2: CMS approved additional 1135 waiver flexibilities requested by Minnesota.
Food & Drug Administration
Treatments and Vaccines
- November 21: The FDA issued emergency use authorization (EUA) for casirivimab and imdevimab, administered together by intravenous (IV) infusion, for the treatment of mild to moderate COVID-19 in adults and pediatric patients.
- November 20: The FDA announced it has scheduled a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10 to examine the Pfizer-BioNTech COVID-19 vaccine candidate.
- November 19: The FDA issued emergency use authorization (EUA) for baricitinib, in combination with remdesivir, for the treatment of suspected for confirmed COVID-19 in hospitalized adults and pediatric patients two year of age or older requiring supplemental oxygen.
- November 9: The FDA issued an emergency use authorization (EUA) for Eli Lilly’s investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.
Personal Protective Equipment (PPE)
- November 24: The FDA published a new page entitled “Face Masks, Including Surgical Masks, and Respirators for COVID-19” in order to answer frequently asked questions (FAQs).
- November 17: The FDA issued an emergency use authorization (EUA) the first COVID-19 test for self-testing at home.
- November 6: The FDA authorized the first serology test that detects neutralizing antibodies from recent or prior COVID-19 infection. All prior serology tests were authorized to test for the presence of biding antibodies.
Federal Emergency Management Agency
- November 23: FEMA updated guidance advising state, tribal, and territorial governments about how to submit coronavirus-related medical staffing requests.
- November 16: FEMA released guidance advising state, tribal, and territorial governments about how to submit coronavirus-related medical staffing requests.
Department of Health and Human Services
- November 24: HHS issued a request for information about effective and innovative approaches/best practices in health care in response to the COVID-19 pandemic. Comments are due Dec. 24 (WHG client summary).
- November 23: HHS and DoD announced a $11.6 million contract with Puritan Medical Products to increase U.S. production of swabs for Cue Health COVID-19 tests.
- November 23: HHS announced plans to allocate initial doses of Regeneron’s investigational monoclonal antibody therapeutic for treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19 at high risk of hospitalization.
- November 19: HHS and DoD announced a $12 million contract with Siemens Healthineers to support domestic production of two coronavirus diagnostic tests.
- November 19: HHS launched a pilot program to use rapid, point-of-care COVID-19 molecular test kits in Alaska, Florida, Louisiana, New Jersey, and Texas.
- November 18: HHS updated its FAQs for the Provider Relief Fund and clarified two key points related to reporting requirements (WHG client summary).
- November 12: HHS announced partnerships with independent pharmacies and regional chains throughout the nation to participate in the federal allocation of future COVID-19 vaccines.
- November 10: HHS announced plans to allocate 300,000 doses of Eli Lilly’s monoclonal antibody therapy, bamlanivimab, to state and territorial health departments, who will then distribute the doses to health care facilities.
- October 31: HHS announced that 389,040 Abbott BinaxNOW COVID-19 rapid tests have been distributed at no cost to 83 Historically Black Colleges and Universities in 24 states.
- October 31: HHS and DoD announced an $12.7 million contract with InBios International to increase production of rapid COVID-19 tests to 20 times current capacity by May 2021.
- October 30: HHS and DoD announced an $119 million agreement with Hologic to expand production capacity for COVID-19 tests to 13 million per month by January 2022.
- October 30: HHS briefed governors on COVID-19 response and vaccine distribution best practices. The agency also released its response to governors’ technical questions.
- October 30: HHS announced that COVID-19 ancillary supply kits will be distributed alongside vaccine orders at no cost to enrolled COVID-19 vaccination providers.
National Institutes of Health
- November 25: The NIH announced the fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4), which will enroll up to 1,500 hospitalized COVID-19 patients to new treatment approaches.
- November 20: The NIH awarded $45 million to expand the research network of the Rapid Acceleration of Diagnostics Underserved Population (RADx-UP) program by adding 20 new institutions and 7 states and territories.
- November 16: The NIH announced that the preliminary data from Moderna’s Phase 3 COVID-19 vaccine trial demonstrates that the candidate (mRNA-1273) is safe and 94.5 percent effective (WHG client summary).
- November 11: The NIH announced the urgent need to develop drugs to treat COVID-19 patients early in the course of the infection.
- November 9: The NIH announced that hydroxychloroquine does not benefit adult hospitalized with COVID-19.
Office of the Inspector General