Summary
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 February.
Centers for Medicare & Medicaid Services
Infection Control and Prevention
- *NEW* February 10: CMS issued new guidance to state survey agencies for visitation at intermediate care facilities for individuals with intellectual disabilities and psychiatric residential treatment facilities during the COVID-19 public health emergency.
State-Specific Disaster Waiver Approvals
- *NEW* February 22: CMS approved a disaster relief SPA requested by Louisiana.
- *NEW* February 22: CMS approved a disaster relief SPA requested by Connecticut.
- *NEW* February 12: CMS approved a disaster relief SPA requested by Massachusetts.
- *NEW* January 19: CMS approved a disaster relief SPA requested by North Dakota.
Food & Drug Administration
Treatments and Vaccines
- *NEW* February 22: The FDA updated guidance on emergency use authorization for vaccines to prevent COVID-19 to provide recommendations on how to address COVID-19 variants.
- *NEW* February 22: The FDA issued new guidance entitled the development of monoclonal antibody products targeting SARS-CoV-2, including addressing the impact of emerging variants, and revised existing guidance on developing drugs and biological products for the treatment or prevention of COVID-19.
- *NEW* February 9: The FDA issued emergency use authorization (EUA) for the combination of bamlanivimab and etesevimab (monoclonal antibodies) for the treatment of mild to moderate COVID-19 in adults and pediatric patients at least 12 years old who are high risk for progressing to severe COVID-19 (WHG client summary).
- *NEW* February 4: The FDA amended the emergency use authorization (EUA) for the use of convalescent plasma as a COVID-19 treatment to high titer plasma use early in the disease course. (WHG client summary).
- *NEW* February 4: The FDA announced an upcoming Vaccines and Related Biological Products Advisory Committee (VRPAC) meeting on February 26 to examine the Janssen Biotech Inc. EUA request for its COVID-19 vaccine candidate.
Diagnostic Testing
- *NEW* February 22: The FDA issued new guidance for test developers on policy for evaluating impact of viral mutations on COVID-19 tests.
- *NEW* February 9: The FDA issued a letter to health care providers on using ventilator splitters in situation in which no alternatives for invasive ventilatory support are available.
Department of Health and Human Services
- *New* February 23: HHS issued a Notification of Enforcement Discretion stating that the HHS OCR will not impose penalties for noncompliance with regulatory requirements under the HIPAA rules for scheduling individual appointments for COVID-19 vaccination (WHG client summary).
- *New* February 11: HHS and the Department of Defense (DOD) announced the purchase of 100 million additional COVID-19 vaccine doses from Pfizer and Moderna.
- *New* February 11: HHS announced a sixth amendment to its declaration under the Public Readiness and Emergency Preparedness (PREP) Act to clarify that federal personnel are protected as qualified persons. (WHG client summary).
- *New* January 29: HHS announced it is extending its designation preventing the hoarding of certain materials needed for the ongoing COVID-19 response through June 20, 2021.
- *New* January 28: HHS issued an amendment to its March 2020 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act to expand the workforce of health care providers who can administer COVID-19 vaccines (WHG client summary).
- *New* January 28: HHS announced the opening of a Special Enrollment Period (SEP) for individuals and families for marketplace coverage in response to the COVID-19 pandemic.
Office of the Inspector General
- *NEW* February 17: OIG updated FAQs about its administrative enforcement authorities related to COVID-19 public health emergency arrangements.
- *NEW* February 4: OIG released a report describing opioid use in Medicare Part D during the first eight months of the COVID-19 pandemic.
- *NEW* January 29: OIG posted new COVID-19 work plan items.
National Institutes of Health
- *NEW* February 24: The NIH announced study findings that people with COVID-19 antibodies have a low risk for future infection.
- *NEW* February 17: The NIH announced the launch of a study that will evaluate remdesivir for COVID-19 in pregnancy women.
- *NEW* February 8: The NIH announced the launch of a clinical trial to evaluate long-acting antibody therapy for individuals hospitalized with COVID-19.
- *NEW* January 29: The NIH announced that the interim analysis of Phase 3 clinical data for the Janssen COVID-19 vaccines demonstrate that the candidate is 66 percent effective at preventing COVID-19 infection.
U.S. Department of Agriculture (Food & Nutrition Service)
- *NEW* February 24: USDA released a fact sheet describing the actions it is taking to contain the COVID-19 pandemic.
- *NEW* February 17: USDA released a fact sheet describing the actions it is taking to contain the COVID-19 pandemic.
Federal Emergency Management Agency
- *NEW* February 16: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency has provided more than $3.38 billion in vaccination expenses to states, tribes, territories, and Washington, D.C.
- *NEW* February 12: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency has provided more than $3.22 billion in vaccination expenses.
- *NEW* February 11: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency has deployed 1,154 staff across the country.
- *NEW* February 10: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency is seeking proposals to contract medical workers to help staff both federally supported and community vaccine centers throughout the country.
- *NEW* February 9: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency has now provided more than $3.15 billion in vaccination expenses and deployed 752 incident management and 317 incident support staff.
- *NEW* February 8: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes the agency has provided more than $2.29 billion in vaccination expenses.
- *NEW* February 5: FEMA released guidance for providing federal support to state, tribal and territorial Community Vaccination Centers.
- *NEW* February 5: FEMA issued a COVID-19 response update describing its vaccine distribution support.
- *NEW* February 4: FEMA issued a COVID-19 response update describing its vaccine distribution support. The report notes that the agency has deployed 449 staff and is operating 130 federally supported sites across the country.
- *NEW* February 3: FEMA released a COVID-19 response update describing its vaccine distribution support. It notes that President Biden has directed the agency to retroactively reimburse states for 100 percent of the costs for eligible emergency protective measures.
- *NEW* February 1: FEMA released a COVID-19 response update describing its vaccine distribution support, detailing the distribution of more than $1 million to states within the last 48 hours.
The White House
- *NEW* February 24: President Biden announced new actions to deliver masks to communities disproportionately impacted by the COVID-19 pandemic (WHG client summary).
- *NEW* February 17: The White House announced new actions the administration is taking to expand and improve COVID-19 testing (WHG client summary).
- *NEW* February 9: The Biden-Harris administration announced in a fact sheet a set of new steps it is taking to expand vaccine distribution and supply in the U.S. We outline these initiatives below (WHG client summary).
- *NEW* February 2: President Biden announced the several actions aimed at increasing COVID-19 vaccinations and federal support to states (WHG client summary).
Congressional Response
Legislation
- *NEW* February 22: House Budget Committee approved the American Rescue Plan Act of 2021.
- *NEW* February 12: House committees marked up legislation under the reconciliation instructions adopted in the Fiscal Year (FY) 2021 Joint Budget Resolution (S.Con.Res.5) – a key step to pass President Joe Biden’s $1.9 trillion American Rescue Plan through budget reconciliation (WHG client summary).
Oversight and Other
- *NEW* February 24: The House Appropriations Subcommittee on LHHS convened a hearing to examine how emergency supplemental appropriations have been used to bolster the federal, state, and local response to the COVID-19 pandemic and discuss ongoing and long-term challenges (WHG client summary).
- *NEW* February 3: The House Energy and Commerce Subcommittee on Health convened a hearing to discuss current and future needs for ramping up on COVID-19 vaccines, testing, and the medical supply chain (WHG client summary).
- *NEW* February 2: The House Energy and Commerce Subcommittee on Oversight and Investigations convened a hearing to examine state perspectives on the COVID-19 vaccine rollout and distribution (WHG client summary).