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 will now be issuing the catalogue at a monthly, rather than biweekly, interval. Below, we have excerpted the pertinent developments that occurred during the month of October.
- October 21: The Senate failed to pass a motion to invoke cloture on the GOP targeted COVID-19 relief package championed by Senate Majority Leader Mitch McConnell (R-KY). Leader McConnell lacked the support of 60 members to overcome the procedural hurdle needed to hold a final vote on the package. The cloture measure failed by a 51-44 vote along party lines. (WHG client summary).
- October 20: The House Ways & Means Subcommittee on Oversight convened a hearing to examine health insurance coverage and the Administration’s efforts to undermine the Affordable Care Act (WHG client summary).
- October 2: The House Select Subcommittee on the Coronavirus Crisis convened a hearing with Department of Health and Human Services (HHS) Secretary Alex Azar to examine the Administration’s political interference in the COVID-19 pandemic response (WHG client summary).
The White House
- October 5: President Trump released an Executive Order (EO) to increase support for mental health needs, citing an increased need as COVID-related shutdowns continue across the country (fact sheet). (WHG client summary).
Centers for Medicare & Medicaid Services
- October 30: CMS announced the launch of the Nursing Home Resource Center, which provides information, guidance, and data for nursing homes combatting the COVID-19 pandemic.
- October 28: the Centers for Medicare & Medicaid Services (CMS) released its fourth COVID-19 interim final rule (IFC), which includes several provisions to prepare for coverage of forthcoming vaccines and treatments for the disease (press release; fact sheet). (WHG client summary).
- October 6: CMS approved additional 1135 waiver flexibilities requested by New York and Pennsylvania.
Food & Drug Administration
- October 22: The FDA approved remdesivir as the first treatment for COVID-19. The drug is approved for use in adults and pediatric patients 12 years of age and older and weighing at least 50 kilograms for the treatment of COVID-19 requiring hospitalization.
- October 20: The Director of the FDA’s Centers for Biologics Evaluation and Research published a blog detailing the FDA’s Vaccines and Related Biological Products Advisory Committee’s role in advising the agency on COVID-19 vaccines.
- October 6: The FDA issued guidance on emergency use authorization (EUA) for COVID-19 vaccines (WHG client summary).
Centers for Disease Control & Prevention
- October 5: CDC updated its “How COVID is Spread” webpage to acknowledge the potential airborne transmission of COVID-19.
Department of Health and Human Services
- October 28: HHS announced it is distributing $333 million in incentive payments, for keeping COVID-19 infection and mortality rates low, to 77 percent of participating nursing homes.
- October 28: HHS and DoD announced an agreement with Eli Lilly to purchase 300,000 doses of the company’s COVID-19 antibody drug for $375 million.
- October 25: HHS announced states have begun reporting information about their plans to use rapid point-of care COVID-19 tests which the administration began distributing in September.
- October 22: HHS revised Provider Relief Fund (PRF) eligibility and reporting requirements for its forthcoming “Phase 3” general distribution (WHG client summary).
- October 21: HHS issued guidance authorizing qualified pharmacy technicians and state-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines, and COVID-19 tests (WHG client summary).
- October 16: Effective October 16, HHS announced that communities that are part of the federal surge testing effort for COVID-19 can now use a saliva test to detect SARS-CoV-2.
- October 16: HHS and DoD announced agreements with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of long-term care facilities with no out-of-pocket costs (WHG client summary).
- October 13: HHS and DoD announced a $31 million agreement with Cytiva to expand manufacturing capacity for the “vaccine-related consumable products” necessary to produce COVID-19 vaccines.
- October 13: HHS, in collaboration with DoD, awarded $481 million to Cue Health, Inc. to expand U.S. production capacity for a cartridge-based point-of-care COVID-19 molecular test. As part of the deal, Cue Health will deliver six million COVID-19 tests and 30,000 instruments to the U.S. government.
- October 9: HHS announced an expanded partnership with AstraZeneca for late-stage development and large-scale manufacturing of the company’s COVID-19 monoclonal antibody cocktail. BARDA and DoD will contribute roughly $486 million for two Phase 3 clinical trials and other development activities.
- October 1: HHS announced a Phase 3 General Distribution of $20 billion from the Provider Relief Fund. The funds will be open to previously ineligible providers and will also permit those who have already received funds to apply for additional funding that considers financial losses and changes in operating expenses due to the pandemic (WHG client summary).
- October 1: HHS announced a pilot program with The Rockefeller Foundation to identify and share effective approaches for using rapid point-of-care antigen tests to screen for COVID-19 in communities, particularly to safely reopen K-12 schools.
- October 1: HHS announced American hospitals can now purchase remdesivir directly from the manufacturer.
Assistant Secretary for Preparedness and Response
- October 19: BARDA announced a partnership with Technical Resources International, Inc. (TRI) to support an adaptive phase 3 clinical trial that will evaluate three immune modulator drugs in treating hospitalized adults with COVID-19.
- October 15: BARDA announced it will fund a clinical trial to validate Beckman Coulter’s method for rapid detection of Multisystem Inflammatory Syndrome in Children (MIS-C), a severe complication of SARS-CoV-2 infection in children.
- October 7: BARDA announced a partnership with Current Health to develop a digital biomarker-based algorithm that can predict the need for hospitalization and ICU level care for patients with COVID-19.
- October 7: BARDA and DoD announced a partnership with Cepheid to develop a single, rapid diagnostic test to detect COVID-19, influenza, and respiratory syncytial virus (RSV).
- October 6: BARDA announced a $22 million, 3-year agreement with Vaxxas to develop a patch that can administer vaccines without traditional needles.
Office of the Inspector General
- October 26: OIG posted new COVID-19 work plan items.
- October 21: OIG updated its COVID-19 fraud alert information.
- October 2: OIG posted new COVID-19 work plan items.
- October 1: OIG posted an audit of the Child Care and Development Fund (CCDF) program. The audit was conducted to provide a national picture of how states dealt with the issues posed by the COVID-19 pandemic in child care settings.
National Institutes of Health
- October 30: The NIH issued a request for information (RFI) to gather public input on the NIH-Wide Strategic Plan for COVID-19 Research (WHG client summary).
- October 28: The NIH announced new research that indicates that biological pathway COVID-19 uses to spread throughout the body, which may provide insight in stopping the transmission of the virus.
- October 13: The NIH announced a new study aimed at determining if certain COVID-19 treatments warrant larger clinical trials.
- October 8: The NIH announced the launch of a clinical trial to test hyperimmune intravenous immunoglobin combined with remdesivir to treat COVID-19.
- October 6: The NIH announced a third round of awards to advanced new COVID-19 testing technologies through the Rapid Acceleration of Diagnostics (RADx) Initiative (WHG client summary).
U.S. Department of Agriculture (Food & Nutrition Service)
- October 23: USDA announced it has authorized $500 million for a fourth round of purchases for the USDA Farmers to Families Food Box Program. USDA is issuing solicitations for the fourth round to existing Basic Ordering Agreement (BOA) holders and expects to award contracts by Oct. 30 for deliveries of food boxes from Nov. 1 through Dec. 31, 2020.
- October 9: USDA announced that it extended waiver flexibilities to allow free meals to continue to be available to all children throughout the entire 2020-2021 school year.
Federal Emergency Management Agency
- October 23: FEMA released a white paper, focused on the mid-Atlantic region, that describes COVID-19’s impact on the human and social services sector.