Congressional Research Service Report: 'FEMA Assistance for Vaccine Administration & Distribution – In Brief'

WASHINGTON, March 13 -- The Congressional Research Service issued the following report (No. R46715) on March 12, 2021, entitled "FEMA Assistance for Vaccine Administration and Distribution: In Brief" by emergency management and disaster recovery analyst Erica A. Lee and health policy analyst Kavya Sekar:

Introduction

Beginning in March 2020, former President Donald J. Trump declared a national emergency, and subsequently declared major disasters for all 50 states, five territories, the District of Columbia, and one tribe for the Coronavirus Disease 2019 or COVID-19 pandemic under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (the Stafford Act, as amended; P.L. 93288)./1

Among the forms of assistance authorized under the Stafford Act declarations was Public Assistance (PA) for Emergency Protective Measures, including PA for vaccination-related costs (e.g., PPE for vaccinators, vaccinator overtime or surge support)./2

Upon assuming office, President Joseph R. Biden expanded the use of PA for vaccination-related costs by increasing the PA federal cost share and initiating an effort to use PA to open and expand vaccination sites. The first federally-run vaccination sites opened on February 16, 2021 (see Chronology). This report provides a brief synopsis of FEMA PA for vaccination-related costs using available data to date.

Chronology--FEMA Assistance for Vaccine Administration and Distribution

* March 13, 2020 - Former President Trump declares an emergency under the Stafford Act, effective for all jurisdictions nationwide, authorizing PA for Emergency Protective Measures.

* March 20, 2020 - Former President Trump begins declaring major disasters for COVID-19 for 50 states, five territories, the District of Columbia, and the Seminole Tribe of Florida. President Biden declares a major disaster for the Navajo Nation on February 2, 2021./3

All declarations reauthorize PA for Emergency Protective Measures.

* October 27, 2020 FEMA - releases Healthcare Resource Roadmap detailing federal assistance for healthcare providers, including for vaccine administration. FEMA specifies that certain vaccination-related costs are eligible for PA./4

* November 19, 2020 - FEMA issues FEMA COVID-19 Vaccination Planning FAQ, further detailing vaccination-related costs eligible for PA./5

* January 21, 2021 President Biden issues National Strategy for the COVID-19 Response and Pandemic Preparedness, which proposes the creation of new federally-supported vaccination sites, including federally-run vaccination sites, as well as increased support for vaccination sites run by SLTT governments./6

* January 21, 2021 President Biden issues Memorandum increasing the federal cost share for FEMA PA, including for eligible vaccination-related costs, from 75% to 100% through September 30, 2021./7

* February 2, 2021 President Biden issues Memorandum that makes the 100% federal cost share for PA, including for eligible vaccination-related costs, retroactive to January 20, 2020./8

* February 4, 2021 FEMA releases Community Vaccination Center Playbook, including planning considerations and requirements for federally-supported vaccination sites./9

* February 16, 2021 New federally-supported mass vaccination sites open in California./10

FEMA's Role in the COVID-19 Vaccination Program

COVID-19 vaccination programs are primarily managed by state, tribal, territorial, and local governments (SLTTs) and supported by the federal government./11

The Department of Health and Human Services (HHS) purchases vaccines as well as some supplies and then allocates these to SLTT governments for weekly ordering and distribution to vaccination sites./12

Other federal agencies, such as the Centers for Disease Control and Prevention (CDC) under HHS, also fund and support SLTT vaccination programs./13

The federal government also separately provides (or is planning to provide) vaccination services directly to patients through federally run efforts, including through retail pharmacy partnerships, federally qualified health centers, and other federal health programs (e.g., Veterans Health Administration)./14

FEMA supplements the federal assistance provided to SLTTs for COVID-19 vaccination programs by reimbursing certain costs and supplying additional direct assistance (e.g., supplies, personnel, and real property) through the PA program. Per Stafford Act Section 312, FEMA may not duplicate assistance provided by other entities, including HHS or private medical insurers./15

FEMA released specific guidance regarding the coordination of federal sources of funding, including PA, for the pandemic response./16

Public Assistance for Pandemic Emergency Response

As noted above, the Stafford Act declarations for the COVID-19 pandemic specifically authorized PA assistance for Emergency Protective Measures, defined as work undertaken to save lives and protect property or public health and safety, or avert the threat of a catastrophe./17

The PA program provides grant assistance to SLTTs as well as eligible nonprofits for the costs of urgent response and long-term recovery work following an emergency or major disaster declared under the act./18

For the pandemic, FEMA is to reimburse SLTTs and eligible nonprofits (PA Applicants) for eligible costs incurred while performing eligible work, including certain vaccination-related activities./19

Public Assistance Funding

PA is funded through the Disaster Relief Fund (DRF), the primary source of funding for Stafford Act assistance./20

DRF funds are typically appropriated for any subsequent eligible use; they are not generally designated for specific emergencies, disasters, or forms of assistance, including PA.

PA is restricted by eligibility, not predetermined funding caps. There is no statutory or regulatory limit on the amount of funding that may be made available to any PA Applicant, declaration, or project--including vaccine distribution and administration--for the COVID-19 pandemic.

100% Federal Cost Share

On January 21 and February 2, 2021, President Biden issued memoranda that expanded FEMA's support for a national vaccination campaign by increasing the PA federal cost share from 75% to 100%, including for vaccination-related costs, from January 20, 2020 to September 30, 2021./21

President Biden also increased the federal cost share from 75% to 100% for the costs of mission assignments mobilizing the National Guard under Title 32 of the United States Code. Eligible work includes that related to vaccine administration and distribution./22

The increased cost share is applicable retroactive to the date of the original authorization (which varies by jurisdiction)./23

Delivering Public Assistance

Like other Stafford Act assistance, the PA program follows a federalist design wherein disaster response is "federally-supported, state-managed, and locally executed." /24

The terms on which PA is provided are set by an agreement established between FEMA and the state, tribe, or territory (also called the PA Recipient) that receives the declaration (the FEMA-State agreement)./25

PA Recipients help FEMA administer PA in the jurisdiction and must comply with relevant statutes, regulations, and agency policy pertaining to the receipt and administration of PA./26

To receive PA funds, Applicants submit documentation of pandemic-related activities and costs to FEMA and the Recipient. FEMA obligates funds for approved costs to the Recipient, who disburses funds to Applicants. For example, FEMA reported obligations of $2.1 million to University of North Carolina Health for its vaccination program. These funds were obligated to North Carolina, who disbursed them to University of North Carolina Health to fund approved work./27

For the pandemic, President Biden issued a memorandum that directed FEMA to expedite and advance partial funding for PA projects, where appropriate and consistent with the law (see Figure 1)./28

Content omitted: Figure 1. Standard and Expedited Funding Process for Large PA Projects

Vaccination-Related Costs Eligible for Public Assistance

FEMA guidance has established that eligible Applicants may request PA for certain costs incurred for COVID-19 vaccine administration and distribution, as detailed in Table 1./29

PA may complement but not duplicate other sources of funding for vaccination programs./30

For this reason, PA is not available for purchase of vaccines or ancillary kits, which are provided at no cost by the federal government./31

As of March 1, 2021, FEMA announced that it had obligated nearly $4 billion in PA for vaccination-related costs./32

In certain cases, PA Applicants may not have the capacity to undertake approved response work, including for COVID-19 vaccination efforts. For example, overwhelmed states may lack the ability to administer and run sufficient numbers of vaccination sites. In these cases, Applicants may request that FEMA provide the assistance directly, called Direct Federal Assistance (DFA)./33

DFA refers to personnel, materials, or operations that the federal government performs or supplies on behalf of the Applicant./34

To provide DFA, FEMA may issue "mission assignments," or work orders that task FEMA personnel or other federal agencies to perform work in response to the pandemic./35

Content omitted: Table 1. Vaccination-Related Costs Eligible for PA

Expanded FEMA Assistance for Vaccination Sites

On January 21, 2021, President Biden released the White House's National Strategy for COVID19 Response and Pandemic Preparedness (hereinafter National Strategy for COVID-19 Response), which included a proposal for federally-supported vaccination sites:

"Knowing that not all states and jurisdictions may have the resources to scale vaccination at the pace this crisis demands, the National COVID-19 Response Team will utilize federal resources and emergency contracting authorities to launch new vaccination sites in support of state and local efforts to best meet local needs. The Department of Defense (DOD) will bring its logistical expertise and staff to bear, with the Federal Emergency Management Agency (FEMA) managing set-up and operations. These sites will mobilize thousands of clinical and non-clinical staff and contractors--including federal medics, Department of Agriculture (USDA) staff, Department of Veterans Affairs (VA) staff, and Public Health Service Commissioned Corps officers and DOD personnel--who will work hand-in-glove with the National Guard and state, territorial, Tribal, and local teams."/36

President Biden proposed to open "100 federally-supported centers" by the end of February, 2021./37

On January 26, 2021, FEMA began releasing regular updates on the implementation of the White House initiative to increase support for vaccine administration and distribution, and specifically the support of vaccination sites./38

Definition of Federally-Supported Vaccination Sites

FEMA and the White House define federally-supported vaccination sites as sites established by Applicants that open, remain open, or expand due to federal support./39

Federally-supported sites may receive federal funding or DFA, including supplies (beyond vaccines or vaccine kits), real property, and/or personnel, including National Guard under Title 32 mission assignments./40

Vaccination sites meeting the above definitions must be operational on or after January 20, 2021, to be defined as federally-supported.

If they meet the above criteria, vaccination sites established and operated by eligible Applicants (e.g., SLTTs or nonprofit medical providers) can be counted as federally-supported vaccination sites. A "federally supported" vaccination site (also referred to as a "community vaccination center" in FEMA guidance) may range from a site that is operated by SLTTs and reimbursed through PA for eligible costs, to a site that is federally leased, managed, operated, and financed./41

Establishment and Operation of Federally-Supported Vaccination Sites

PA for vaccination sites, like other PA, generally follows the terms of the FEMA-State Agreement executed between FEMA and the Governor or Tribal Chief Executive./42

In general, the Stafford Act authorizes the federal government to deliver PA upon request, not unilaterally./43

FEMA has provided detailed information regarding the specific staffing requirements, layouts, circulation models, and supply requirements for five different types of federally-supported vaccination sites (see Table 2)./44

Via FEMA mission assignment, the U.S. Army Corps of Engineers (USACE) developed conceptual designs for drive-thru and walk-thru sites, and may provide technical assistance for site design./45

FEMA may also provide real property and/or provide mobile facilities for vaccination sites./46

FEMA guidance recommends that officials managing vaccination centers determine the quantity of vaccines that may be expected from state, tribal, and territorial allocations, and further notes that the state, tribe, or territory is "always the agency that determines both the quantity and delivery date of any vaccine allocation to any CVC [Community Vaccination Center] site." /47

As of March 1, 2021, FEMA announced that 450 community vaccination centers and 37 mobile vaccination centers were receiving federal support nationwide./48

The White House reported that 171 sites are being supported by federal personnel from nine different agencies, 312 sites are staffed with support from National Guard members under Title 32 mission assignments, 177 sites are receiving financial assistance through FEMA PA, and 62 sites have received federal equipment as of February 26, 2021./49

Federal Pilot Sites

The White House has explained that FEMA has piloted a small number of sites wherein "the federal government is directly working with state and local partners from start to finish, to help select the location for, staff, and operate these sites."/50

As of February 26, 2021, the White House announced that 18 sites in the pilot program had opened in California, Texas, and New York, and that 11 additional pilot sites will soon open in Florida, New York, Pennsylvania, Illinois, and North Carolina./51

FEMA reports that vaccination sites launched through FEMA's pilot program for federally established community vaccination centers may receive vaccine allocations above and beyond a jurisdiction's regular allocation./52

Content omitted: Table 2. Community Vaccination Site Models

Site Selection

In accordance with the federalist design of assistance authorized under the Stafford Act, FEMA explains that vaccination site plans and operations "must be coordinated with STT [state, tribal, and territorial, or PA Recipients] authorities to support access to vaccination in jurisdictions." /53

FEMA guidance on federally-supported vaccination sites further explains that site selection is to be "needs based, data driven, and in support of STT [state, tribal, and territorial] requests." /54

To determine site location, FEMA works in concert with state, tribal, territorial, and local officials, including public health and emergency management officials, as well as representatives of the FEMA Civil Rights Advisory Group and Office of Disability Integration Coordination./55

According to FEMA, considerations include, but are not limited to, on-site security, public transportation access, outreach, and other effects and requirements specific to a given community.

FEMA reports that Federal Pilot Sites will be chosen in part using data analysis that includes CDC's Social Vulnerability Index./56

Requirements

CDC and FEMA PA Requirements

FEMA policy restricts PA for vaccination-related costs to those necessary to administer vaccines consistent with CDC guidance, including CDC provider agreements./57

Any provider who participates in the COVID-19 vaccination program must be credentialed/licensed or otherwise authorized in the jurisdiction where vaccination takes place and sign and agree to the conditions in the CDC COVID-19 Vaccination Program Provider Agreement. The agreement includes requirements related to vaccine storage, handling, data reporting, and reimbursement, among others./58

PA Applicants seeking PA reimbursement or DFA for vaccine administration must also meet the extensive eligibility and program requirements of the PA program./59

Equity

Some Members of Congress have raised concern about equitable vaccine distribution following reports that racial and ethnic minority groups may have been underrepresented in the population that received vaccines during the first month of the COVID-19 vaccination program./60

The Stafford Act requires FEMA to promulgate rules ensuring that the distribution of Stafford Act Assistance is delivered "in an equitable and impartial manner, without discrimination on the grounds of race, color, religion, nationality, sex, age, disability, English proficiency, or economic status."/61

Federal regulations also require PA Recipients to deliver disaster assistance equitably./62

The White House, FEMA, and the CDC have all underscored the importance of equitable vaccine distribution. The White House National Strategy for COVID-19 Response says that federally-supported vaccination sites will "help us reach underserved communities and those that have been hit the hardest by this pandemic."/63

FEMA's Community Vaccination Centers Playbook includes in its mission the "timely and equitable distribution and administration of COVID-19 vaccines." /64

CDC's recommendations regarding vaccine prioritization are meant to address three goals, one of them to "[r]educe the extra burden COVID-19 is having on people already facing disparities." /65

In accordance with these goals, FEMA established the Civil Rights Advisory Group (CRAG) in January 2021 to "evaluate the policies, practices, strategies and plans in place to identify and eliminate inequities."/66

According to FEMA, the group collaborates with SLTT and federal officials managing vaccination efforts; Civil Rights advisers may be deployed across all FEMA regions to promote equity in site selection and vaccine distribution./67

As of February 10, 2021, the CRAG drew from offices within FEMA, the Department of Homeland Security, the U.S. Department of Housing and Urban Development, and several HHS components, namely the Office of Civil Rights (OCR), the Assistant Secretary of Preparedness and Response (ASPR), the Administration for Community Living (ACL), and the CDC.

FEMA's Community Vaccination Centers Playbook identifies specific requirements and considerations for federally-supported vaccination centers that may promote equity and accessibility. For example, FEMA specifies that the agency's regional operations centers, the Regional Response Coordination Centers (RRCCs), must work with states, tribes, and territories to develop plans that address the vaccination of homebound residents, as well as those with mobility limitations or limited access to transportation./68

FEMA released an itemized list of civil rights considerations to inform state, tribal, and territorial planning for vaccination sites./69

Data Collection

Missing or unreported demographic data on vaccine recipients has reportedly hindered federal efforts to understand and remediate inequities in vaccine programs./70

Per the CDC provider agreement, vaccine providers are generally required to report daily data on vaccine recipients (including data on race/ethnicity and other demographic information) to SLTT public health agencies that then report to CDC./71

Despite this requirement, not all states are reporting race and/or ethnicity data on vaccine recipients./72

FEMA's Office of Equal Rights released an advisory on February 6, 2021, that reminds PA Recipients and Applicants of their responsibility to collect and submit demographic data, when requested, to ensure compliance with civil rights law./73

Federal statute and regulations require that PA Recipients and Applicants collect data necessary to demonstrate compliance with civil rights laws and enable FEMA to verify compliance./74

For the purposes of compliance with the laws, regulations, and policies designed to ensure nondiscrimination and uphold FEMA's civil rights obligations, FEMA says that PA Applicant data sets--including those of Applicants requesting PA for vaccination-related costs--should include geographic and demographic information about populations being served, including race, national origin, English proficiency, age, and disability status./75

Applicants receiving PA for vaccine administration must also comply with data requirements in CDC Provider Agreements./76

* * *

View report, tables and footnotes at https://crsreports.congress.gov/product/pdf/R/R46715