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Yesterday, President Biden’s first full day in office, the new administration released the full details of the National Strategy for the COVID-19 Response and Pandemic Preparedness. To execute the plan, the Biden Administration will establish a COVID-19 Response Office that will be responsible for coordinating the pandemic response across federal agencies. Elements of the plan will be achieved through administration action and Executive Order, or will require legislation, as noted below, as well as appropriations. Many of these strategies would allocate resources based on how hard a community has been hit (undefined) by the COVID-19 pandemic, and these determinations will likely be made by the Biden Administration upon implementation and on a rolling basis.  The President signed a number of other Executive Orders related to COVID19 which are summarized in this document.  AGS was delighted to see the emphasis on ensuring health equity in these additional orders given the tremendous impact of COVID-19 on communities of color.

As reported in my previous post, the National Strategy is focused on seven specific goals for combating the COVID-19 pandemic.  Thanks to our legislative and regulatory team at Arnold & Porter, we have some additional details to share today (summarized below).  In addition to the national plan, the administration released a list of the individuals hired to date who will have responsibility for executing the plan.  The expectation is that this group will be expanded over time.

In an update to our reporting on the invocation of the National Defense Production Act, the Executive Order broadly covers everything that the nation needs to fight the COVID-19 pandemic, including ensuring a sufficient supply of personal protective equipment which is something AGS has long advocated for.

Show Me the Money: Look for a Member Advocacy Alert Next Week

The new administration has some funding to get started on this ambitious plan – including funds that were appropriated by Congress in the COVID-19 package passed before the holidays.  However, for the nation to be successful in combatting COVID19,  it will be critically important that Congress take legislative action on the President’s proposed American Relief Plan which includes a request for more funding to fight the pandemic.  AGS members should look for an advocacy alert next week and we hope that you will take action and share with your legislators why it is critical that they pass legislation.

Detailed Summary of the National Strategy on COVID-19

1. Restoring trust with the American people

• Establish a national COVID-19 response structure where decision-making is driven by science and equity (See Executive Order Organizing and Mobilizing the U.S. Government to Provide a Unified And Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health Security which establishes a White House COVID-19 national response structure to coordinate across the U.S. government and restores the White House Directorate on Global Health Security and Biodefense).
• Conduct regular expert-led, science-based public briefings.
• Publicly share data around key response indicators (See Executive Order Ensuring a Data-Driven Response to COVID-19 and Future High Consequence Public Health Threats which directs the Secretary of Defense, the Attorney General, the Secretary of Commerce, the Secretary of Labor, the Secretary of Health and Human Services (HHS), the Secretary of Education, the Director of the Office of Management and Budget (OMB), the Director of National Intelligence, the Director of the Office of Science and Technology Policy (OSTP), and the Director of the National Science Foundation to promptly designate a senior official to serve as their agency’s lead to work on COVID-19 and pandemic-related data issues.  These officials, in consultation with the COVID-19 Response Coordinator, must take steps to make data relevant to high-consequence public health threats, such as the COVID-19 pandemic, publicly available and accessible).
• Engage the American people by prioritizing outreach to State and local governments, the public and private sectors, vulnerable communities, students, workers, and community leaders.
• Lead science-first public health campaigns.

2. Mounting a safe, effective, and comprehensive vaccine plan

• Ensure the availability of safe, effective vaccines for the American public by fully leveraging the Defense Production Act (DPA), deploying onsite support to monitor contract manufacturing operations, and purchasing additional Food and Drug Administration (FDA)-authorized vaccines. This effort will prioritize supplies such as glass vials, stoppers, syringes, needles, and the "fill and finish" capacity to package vaccines into vials.
• Accelerate vaccinations and distribution of vaccines to the communities that need them most by encouraging States and localities to move through priority groups quickly and expanding access to frontline essential workers.
• Create as many venues as needed for people to get vaccinated by partnering with State and local governments.
• Focus on hard-to-reach and high-risk populations by deploying targeted strategies to meet the needs of individuals at increased risk, those who need to take extra precautions, and communities hit hardest by this pandemic.
• Fairly compensate providers, and State and local governments for the cost of administering vaccines through an expanded Federal Medicaid Assistance Percentage (FMAP) increase to 100 percent for vaccinations for Medicaid enrollees, which would require legislation. HHS will also ask the Centers for Medicare & Medicaid Services (CMS) to consider whether payment rates for vaccine administration are appropriate or whether a higher rate may more accurately compensate providers. To plan would also allow State and local governments to reimburse vaccination administration expenses through the Federal Emergency Management Agency (FEMA) Disaster Relief Fund.
• Drive equity throughout the vaccination campaign and broader pandemic response by using demographic data to identify communities hit hardest and providing them vaccines at no out-of-pocket costs.
• Launch a national vaccinations public education campaign.
• Bolster data systems and transparency for vaccinations by having the Federal government and the Centers for Disease Control and Prevention (CDC) work with States and localities to track distribution and vaccine progress.
• Monitor vaccine safety and efficacy by utilizing expanded and existing systems in the CDC and FDA to ensure ongoing, real-time safety monitoring.
• Surge the health care workforce to support the vaccination effort by taking steps to allow qualified professionals to administer vaccines and encourage States to leverage their workforce, including by expanding scope of practice laws and waiving licensing requirements as appropriate.

3. Mitigating spread through expanding masking, testing, data, treatments, health care workforce, and clear public health standards

• Implement masking nationwide by working with governors and mayors (See Executive Order Protecting the Federal Workforce and Requiring Mask-Wearing which directs compliance with CDC guidelines on masking and physical distancing in federal buildings, on federal lands, and by federal employees and contractors).
• Scale and expand testing by implementing a national testing strategy (See Executive Order Establishing the National Pandemic Testing Board and Ensuring a Sustainable Public Health Workforce for COVID-19 and Other Biological Threats which establishes the COVID-19 Pandemic Testing Board to oversee implementation of a unified approach to testing).
• Prioritize therapeutics and establish a comprehensive, integrated preclinical drug discovery and development program, with diverse trials to allow treatments to be evaluated and developed rapidly, with a focus on those that can be scaled/administered readily. This includes support for developing broad spectrum antivirals to prevent future viral pandemics (See Executive Order Improving and Expanding Access to Care and Treatment for COVID-19 which outlines steps to bolster clinical care capacity, provide assistance to long-term care facilities and intermediate care facilities for people with disabilities, increase health care workforce capacity, expand access to programs designed to meet long-term health needs of patients recovering from COVID-19, and support access to safe and effective COVID-19 therapies for those without coverage).
• Develop actionable, evidence-based health guidance by requiring the CDC to develop and update public health guidance on containment and mitigation metrics for measuring and monitoring the incidence and prevalence of COVID-19 in health care facilities, schools, workplaces, and the general public.
• Expand the U.S. public health workforce and increase clinical care capacity for COVID-19 by establishing a U.S. Public Health Jobs Corps, providing support for community health workers, and mobilizing Americans to support communities most at-risk.
• Improve data to guide the response to COVID-19 by requiring agencies to collect, aggregate, share, and analyze non-personally identifiable data, and take steps to make it publicly available and in a machine-readable form to enhance COVID-19 response efforts.

4. Immediate expansion of emergency relief and exercise of the Defense Production Act

• Increase emergency funding to States and bolster FEMA response, (See Presidential Memorandum entitled Extend Federal Support to Governors’ Use of National Guard to Respond to COVID-19 and to Increase Reimbursement and other Assistance Provided to States which directs FEMA to fully reimburse States for the cost of National Guard personnel and emergency supplies).
• Fill supply shortfalls by invoking the Defense Production Act (DPA). (See Executive Order A Sustainable Public Health Supply Chain, which directs agencies to fill supply shortfalls using all available legal authorities, including but not limited to the DPA).
• Identify and solve urgent COVID-19 related supply gaps and strengthen the supply chain by increasing the domestic supply chain in critical sectors such as antigen and molecular-based testing, personal protective equipment (PPE) and durable medical equipment, vaccine development and manufacturing, and therapeutics and key drugs.
• Secure the pandemic supply chain and create a manufacturing base in the U.S. by utilizing the new Pandemic Supply Chain Resilience Strategy to be developed by the Secretary of Defense, the Secretary of HHS, and the Secretary of Homeland Security, in coordination with the Assistant to the President for National Security Affairs (APNSA), the Assistant to the President for Domestic Policy, the COVID-19 Response Coordinator, and the heads of any agencies or entities selected by the APNSA and COVID-19 Response Coordinator, which shall provide to the President a strategy to design, build, and sustain a long-term capability in the U.S. to manufacture supplies for future pandemics and biological threats. 
• Improve distribution and expand availability of critical materials by directing the Department of Defense, HHS, the Department of Homeland Security (DHS) to develop recommendations to address the pricing of COVID-19 supplies.

5. Safely reopening schools, businesses, and traveling while protecting workers

• Implement a national strategy to support safely reopening schools, (See Executive Order Supporting the Reopening and Continuing Operation of Schools and Early Childhood Education Providers which directs a national strategy for safely reopening schools, including requiring the Departments of Education and HHS to provide guidance on safe reopening and operating, and to develop a Safer Schools and Campuses Best Practices Clearinghouse to share lessons learned and best practices from across the country).
• Support safe operations at child care centers and at-home providers through additional Congressional funding, which would require legislation.
• Support equitable reopening and operation in higher education through additional Congressional funding, which would require legislation.
• Protect workers and issue stronger worker safety guidance, (See Executive Order Protecting Worker Health and Safety which directs the Occupational Safety and Health Administration (OSHA) to issue updated guidance on COVID-19 worker protections).
• Provide guidance and support to safely open businesses by prioritizing funding made available by the Consolidated Appropriations Act, 2021 (P.L. 116-260) to the companies hit hardest by COVID-19 and by requiring the Small Business Administration to work with the Department of Labor to disseminate updated OSHA guidance.
• Promote safe travel, (See Executive Order Promoting COVID-19 Safety in Domestic and International Travel which requires a negative COVID-19 test result prior to departure and quarantine on arrival, as well as directing agencies to develop options for expanding public health measure for domestic travel via public modes of transportation).

6. Protecting those who are most at risk and advancing equity, including across racial, ethnic, and rural/urban lines

• Establish the COVID-19 Health Equity Task Force to address COVID-19 related health and social equities.
• Increase data collection and reporting for high risk groups by directing federal agencies to expand their data infrastructure to increase collection and reporting of health data for high risk populations and requiring HHS to prioritize data collection from public and private entities to increase the availability of data by race, ethnicity, geography, disability, and other demographic variables.
• Ensure equitable access to critical COVID-19 PPE, tests, therapies and vaccines by requiring CDC to work with States and localities.
• Expand the clinical and public health workforce, including community-based workers through the new United States Public Health Workforce Program and by deploying federal workers to assist with the COVID-19 response in under-served areas.
• Strengthen the social service safety net to address unmet basic needs by requesting additional funds from Congress to provide paid sick leave, child care support, and rental assistance, which requires legislation.
• Support communities most at-risk for COVID-19 by requiring the CDC to develop and update clear public health guidance for such high-risk populations and settings to further minimize the risk of COVID infection, and work with states to update their pandemic plans to incorporate such guidance as necessary.

7. Restoring U.S. leadership globally and building better preparedness for future threats 

• Restore the U.S. relationship with the World Health Organization (WHO) and seek to strengthen and reform it. President Biden sent letters informing the United Nations (UN) Secretary General and the WHO Director General of his decision to cease the Trump Administration's process of withdrawing the U.S.
• Surge the international COVID-19 public health and humanitarian response by supporting support the Access to COVID-19 Tools (ACT) Accelerator, join the COVID-19 Vaccines Global Access (COVAX) Facility, and seek to strengthen other existing multilateral initiatives, such as the Coalition for Epidemic Preparedness Innovations; Gavi, the Vaccine Alliance; and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
• Restore U.S. leadership to the international COVID-19 response and advance global health security and diplomacy by advancing global health security financing, promoting efforts to harmonize crisis response and early warning for public health emergencies, and strengthening global pandemic supply chains and by working within the UN Security Council.
• Build better biopreparedness and expand resilience for biological threats by restoring the White House National Security Council Directorate for Global Health Security and Biodefense and seeking to secure funding to establish an integrated, National Center for Epidemic Forecasting and Outbreak Analytics to modernize global early warning and trigger systems to prevent, detect, and respond to biological threats. This would require Congressional support and legislation.