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FundingPublicHealthEmergencyPreparedness.pdf

Funding Public Health Emergency Preparedness in the United States

The historical precedents that

support state and local leader-

ship in preparedness for and re-

sponse to disasters are in many

ways at odds with the technical

demands of preparedness and

response for incidents affecting

public health.

New and revised laws and

regulations, executive orders,

policies, strategies, and plans

developed in response to bi-

ological threats since 2001

address the role of the federal

government in the response

to public health emergencies.

However, financial mechanisms

for disaster response—especially

those that wait for gubernatorial

requestbeforefederalassistance

can be provided—do not align

with the need to prevent the

spread of infectious agents or

efficiently reduce the impact

on public health.

We review key US policies

and funding mechanisms rele-

vant to public health emergen-

cies and clarify how policies,

regulations, and resources af-

fect coordinated responses.

(Am J Public Health. 2017;107:

S148–S152. doi:10.2105/AJPH.2017.

303956)

Rebecca Katz, PhD, MPH, Aurelia Attal-Juncqua, MS, and Julie E. Fischer, PhD

Emergency preparedness andresponse start at the local level, with the city and county officials, state governors, and tribal leaders who are the first to respond to any disaster. Author- ities over emergency manage- ment functions are historically delegated to state and local gov- ernments. Responsibilities for bi- ological threats rest with state and local public health departments, emergency response agencies, and public and private health care in- stitutions—organizations that of- ten lack clear funding mechanisms or well-defined authorities for sustained preparedness activities, with no shortage of competing priorities.1 Large-scale events, however, often exceed local management capacities, leading to federal interventions. In 2016 alone, the federal government made assistance available to state governments for 103 declared di- sasters and emergencies, including fires, natural disasters, and one public health crisis caused by manmade water contamination.2

We outline legal and funding mechanisms in the United States to clarify federal policies, regu- lations, and resources that affect coordinated responses at all levels of government to infectious dis- ease outbreaks and other bi- ological health crises.

EMERGENCY PREPARDENESS AND PLANNING

In the last 15 years, the federal government reframed the roles

and responsibilities for emer- gency preparedness and response, particularly for biological events. After the terrorist attacks of September 11, 2001, Congress approved the creation of the Department of Homeland Se- curity (DHS) to act “as a focal point regarding natural and manmade crises and emergency planning” for the federal gov- ernment.3 Following the 2001 anthrax assaults, Congress also granted new resources and au- thorities to the Department of Health and Human Services (HHS) and its operating di- visions, including the Centers for Disease Control and Pre- vention (CDC), to coordinate preparedness and response for bioterrorism and other events.4

Widespread coordination failures during Hurricane Katrina in 2005, including in the federal response to complex public health challenges that followed the storm, underscored the lim- ited capabilities of the DHS to organize federal response activi- ties as well as ambiguities in na- tional guidance for “all-hazards” emergency preparedness and re- sponse. The Katrina experience, coupled with concerns over the emergence of potentially pan- demic influenza, prompted

Congress to establish the office of Assistant Secretary for Pre- paredness and Response within the HHS and to strengthen fed- eral programs to mobilize assis- tance to states for immediate and extraordinary action to protect public health.5

In addition to the establish- ment of new offices, the federal government created a series of planning and guidance docu- ments to better coordinate pre- paredness and response efforts. The National Response Frame- work defines the general roles, responsibilities, and coordination structures for federal, state, and local entities during all types of disasters or emergencies.6 The Emergency Support Function and Support Annexes to the National Response Framework outline how federal agencies will provide coordinated assistance in core areas commonly required for disaster response. The In- cident Annexes to the Federal Interagency Operational Plan similarly address coordination of the federal response to specific risks and threats. Both the Public Health and Medical Services Annex (Emergency Support Function #8) and the Biological Index Annex designate the HHS the coordinating agency for federal preparedness and

ABOUT THE AUTHORS Rebecca Katz, Aurelia Attal-Juncqua, and Julie E. Fischer are with the Center for Global Health Science and Security, Georgetown University Medical Center, Washington, DC.

Correspondence should be sent to Rebecca Katz, 305 SW Medical Dental Bldg, 3900 Reservoir Rd NW, Washington, DC 20057 (e-mail: [email protected]). Reprints can be ordered at http://www.ajph.org by clicking the “Reprints” link.

This article was accepted March 25, 2017. doi: 10.2105/AJPH.2017.303956

S148 Commentary Peer Reviewed Katz et al. AJPH Supplement 2, 2017, Vol 107, No. S2

AJPH POLICY

coordination regarding public health events.7

When Local Resources Are Overwhelmed

Federal planning guidance assumes that state and local au- thorities will lead the initial re- sponse to a disaster or emergency, with federal measures coming into play only under certain conditions. The federal response to disasters or emergencies can be activated through four possible routes: (1) a presidential decla- ration under the Stafford Act, (2) a presidential declaration under the National Emergen- cies Act (NEA), (3) declaration of a public health emergency by the secretary of the HHS, or (4) congressional action to enact legislation for supplemental appropriations.8 The pathway generally depends on the type of emergency or disaster. Table 1 summarizes recent actions to

mobilize federal resources and briefly describes their outcomes.

The Stafford Act. The main legal authority for providing federal support during a disaster or an emergency is the Robert T. Stafford Relief and Emergency Assistance Act. If an incident is deemed beyond the capabilities of an affected state, the governor can submit a request for a disaster declaration to the president via one of ten regional offices of the Federal Emergency Management Agency (FEMA), identifying needs and specific requests for support from the federal gov- ernment.9 During fiscal year (FY) 2004 through FY2011, the president approved 539 of 629, or 86%, of governors’ requests for disaster declarations.10 Between FY2012 and June 2017, there were an additional 284 major disaster declarations.11

The type of federal assistance andfunding that can be authorized under the Stafford Act depends on

the type of declaration issued by the president—either a “major disaster” or an “emergency.” The declaration of a major disaster (defined as any natural catastrophe, including a hurricane, storm, earthquake,drought,fire,orflood, that exceeds state and local re- sponse capabilities) provides broad authorities for federal assistance, including support for essential services and supplies, reducing immediate threats to public health and safety, and restoring in- frastructure; it also supports long- term assistance to mitigate hazards to the community and aid to af- fected individuals and households. The Stafford Act defines an emergency more broadly as any occasion in which federal assis- tanceisrequiredtosavelivesandto protect property and public health and safety or to lessen or avert the threat of a catastrophe. An emer- gency declaration also authorizes federal emergency assistance to state and local governments, but

the scope of assistance is limited to emergency protective measures (excluding “permanent” hazard mitigation efforts). There is no cap on the amount of funds that can be made available for a major disaster, but there is a $5 million cap for emergencies.

When the 2000 West Nile virus outbreak in New York and New Jersey received an emer- gency declaration under the Stafford Act, it set a precedent for using this mechanism to mobilize federal assistance during an infectious disease outbreak. Outbreaks, however, are not included in the Stafford Act definition of major disasters, and there is no precedent for de- claring a biological event a major disaster.12,13

The National Emergencies Act. The NEA does not directly au- thorize federal assistance pro- grams or any specific funding. Instead, the NEA authorizes the president to declare a national

TABLE 1—Previous Public Health Events and Routes for Funding

Past Areas of Public Health Concern

Past Incidents of Public Health Concern

2000 West Nile Virus Outbreak, New Jersey

2005 Hurricane Katrina, Louisiana 2009 H1N1 Pandemic 2014 Ebola Outbreak

2016 Zika Outbreak, Puerto Rico & Florida

Gubernatorial

request for

assistance

Yes Yes No No Florida: No

Puerto Rico: Yes

Type of

declaration

issued

Presidential Emergency

Declaration under the

Stafford Act

Presidential Emergency

Declaration under the

Stafford Act; Presidential

Major Disaster Declaration

under the Stafford Act

HHS secretary declared

a nationwide public health

emergency under section 319

of the Public Health Service

Act; Presidential Declaration

of National Emergency

HHS secretary declared

a public health emergency

in Puerto Rico under section

319 of the Public Health

Service Act

Funding

provided

$2.44 million in Public

Assistance grants; $2.44

million in Emergency Work

$19.6 billion in Individual

Assistance, Public Assistance,

and Hazard Mitigation grant

programs (over a decade)

Presidential request for

emergency supplemental

appropriations granted:

$6.15 billion (and $5.80 billion

in additional contingent

funding); $4.54 billion of $5.8

billion contingency funding

provided

Presidential Emergency

Funding request for $6.16

billion with $5.4 billion

granted: $3.7 billion for

international efforts,

$1.1 billion for the domestic

response, $515 million for

R&D

Presidential Emergency

Funding request for $1.9

billion (February 2016) with

$1.1 billion granted as part

of Continuing Resolution

(September 2016)

Note. HHS = US Department of Health and Human Services; R&D = research and development.

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emergency, which in turn allows the president to activate emer- gency provisions in other statutes and executive orders.14 The NEA grants the president ex- traordinary powers to respond to threats to the safety or well-being of the American people, under strong (if rarely exercised) con- gressional checks.15

In October 2009, the presi- dent declared the H1N1 in- fluenza pandemic a national emergency, authorizing the secretary of the HHS (under emergency provisions in Section 1135 of the Social Security Act) to temporarily waive certain re- quirements under Medicare, Medicaid, the State Children’s Health Insurance Program, and the Health Insurance Portability and Accountability Act. This permitted US health care facilities increased flexibility in providing affected populations with access to care.16

Public Health Service Act. Under section 319 of the Public Health Service Act, the HHS secretary may declare a disease, disorder, outbreak, or bioterrorist attack a public health emergency (PHE).17 The HHS secretary declared a PHE for H1N1 in- fluenza in the United States in 2009 and for Zika virus in Puerto Rico in 2016.18 PHE declara- tions allow the HHS to waive certain federal regulatory and reporting requirements (in some cases, only after the concomitant declaration of a national emer- gency or major disaster); enter into grants and contracts as needed; allow states to tempo- rarily reassign personnel sup- ported with federal funds; and mobilize federal resources (di- rectly and through assistance to states) to support disease surveil- lance, investigations, and control measures. A PHE declaration also authorizes the secretary to access

federal funds from the Public Health Emergency Fund.19,20

Federal Funding Federal public health pre-

paredness programs are generally funded through routine con- gressional appropriations. Ap- propriations for domestic health security fluctuate from year to year and do not necessarily in- clude contingency funds to re- spond to biological events. When an emergency or crisis arises, additional funds may be mobi- lized through special contin- gency funds or through congressional supplemental ap- propriations. Since 2003, Con- gress has approved emergency supplemental appropriations for SARS, H5N1, H1N1, Ebola, and Zika. During the West Af- rican Ebola crisis in 2014 and 2015, for example, Congress appropriated $5.4 billion through emergency supplemental fund- ing for preparedness and re- sponse, 69% of which was

dedicated to the international response; the remainder went toward domestic efforts ($1.1 billion) and research and devel- opment ($515 million).21

The Disaster Relief Fund (DRF), managed by FEMA, is the primary source of funds for federal assistance to states fol- lowing the declaration of a major disaster or emergency under the Stafford Act. The DRF receives congressional appropriations an- nually; funds remain available until used and are carried over at the end of the fiscal year.22 In FY2016, Congress allocated $661 million in base funding to the DRF, in addition to its car- ryover balance.23

The Public Health Emer- gency Fund (PHEF; Figure 1), created in 1983, falls under the authority of the HHS. The HHS secretary is authorized to access PHEP funds following the declaration of a PHE. Like the DRF, the PHEF was established as a “no year”

account, with an initial appro- priation of $30 million.21 How- ever, no appropriations to the PHEF since FY1999 have been noted; the account maintains a zero balance since at least 2012.19 Nei- ther Congress nor recent admin- istrations have explicitly addressed the steady exhaustion of funding in the PHEF as a deliberate policy decision.

RECOMMENDATIONS The mere existence of federal

mechanisms to mobilize assis- tance to state and local govern- ments does not guarantee adequate and timely funding during an outbreak (especially since the “no year” PHEF was depleted in 2012). In February 2016, the Obama administration requested $1.9 billion in emergency funding for Zika virus research and response efforts. Political contentions delayed passage of emergency

Public Health

Emergency Occurs

Public Health

Emergency

Declaration by

the HHS

Secretary

NEA Presidential

Declaration

NO DESIGNATED FUNDING

CONVEYED

Authority of the

HHS Secretary to

provide support

from the Public

Health Emergency

Fund

FUND EMPTY

Authority of the

President/FEMA to

provide support

from the Disaster

Relief Fund

$5 MILLION CAP

Stafford Act

Presidential

Major Disaster

Declaration

NOT ELIGIBLE

Stafford Act

Presidential

Emergency

Declaration

Note. FEMA = Federal Emergency Management Agency; HHS = Department of Health and Human Services; NEA = National Emergencies Act.

FIGURE 1—Federal Funding Mechanisms in the Rapid Response to an Infectious Disease or Biological Public Health Emergency: United States

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S150 Commentary Peer Reviewed Katz et al. AJPH Supplement 2, 2017, Vol 107, No. S2

appropriations legislation ac- ceptable to both Congress and the White House. In August 2016, the HHS secre- tary declared the Zika virus outbreak a PHE in Puerto Rico. This declaration tech- nically permitted the govern- ment of Puerto Rico to apply for funding for prevention and response activities, but the exhaustion of the PHEF lim- ited viable options. At the end of September 2016, Congress agreed to provide $1.1 billion to support Zika virus pre- vention, control, and research as part of a continuing resolu- tion.24 In the meantime, more than 30 000 cases were re- ported in Puerto Rico and 139 locally acquired cases were reported in Florida by the be- ginning of November 2016.25

Decision-makers at many levels have called for new— sometimes exceptional— coordination and funding mech- anisms for responses to Zika and other biological events. For ex- ample, in 2016, Representative Rosa DeLauro proposed to up- date the PHEF Act, including allocating $5 billion to the ex- isting PHEF. Representatives Hal Rogers and Kevin McCarthy introduced legislation to create an alternative $300 million emer- gency fund for public health crises, referred to as a “FEMA for public health,” as part of a larger health spending bill.26 Reasons for developing a novel funding mechanism, as opposed to fund- ing the existing PHEP (with or without statutory changes for activating funds), have not been articulated.

In order for the federal gov- ernment to be better prepared to respond rapidly to emerging bi- ological threats and PHEs, we propose a series of recommen- dations to enhance coordination, ensure expeditious funding

appropriations, and maintain ac- countability. We recommend (1) revitalizing the PHEF, (2) im- proving federal coordination, and (3) identifying clear triggers for action.

Recommendation 1: Revitalizing the PHEF

A standing fund to support federal assistance to state and local governments during outbreaks and other PHEs does not have to be created “from scratch,” as the PHEF already exists. The 1983 law authorizing the PHEF should be updated as needed, starting with an annual appro- priation proportionate to state and local needs during recent outbreaks.

Recommendation 2: Agency Coordination

Making the PHEF viable creates the need for clear co- ordination between the DHS and HHS on types of disasters, phases of funding, and determination of lead agency. A PHE declaration by the HHS secretary will allow mobilization of funds immedi- ately for a timely and effective response to outbreaks, without waiting for a state request. It will need to be determined, however, whether a PHE declaration ef- fectively preempts a declaration under the Stafford Act, whether funds will have to be committed or expended within the 90-day window of the PHE declaration, and whether there will be a ceil- ing on PHEF awards to state and local governments. Alternatively, it may be decided that there should be a process by which states could request a major di- saster declaration following the immediate response to the out- break, allowing a transition to hazard mitigation funding and the forms of public assistance allowed under the Stafford Act. Federal

entities will need to work together closely to answer these questions, provide guidance to state and local partners,andcreatetrackingsystems to ensure that funds are spent ap- propriately to mitigate the conse- quences and recover from a PHE.

Recommendation 3: Mobilization Triggers

Reinvigorating the PHEF also requires the development of clear triggers to define contingencies under which the HHS secretary should immediately consider a PHE declaration. State-level laboratories and epidemiologists contribute to the rapid detection of emerging public health events and communicate information on biological risks to both senior state and federal officials. Rou- tinely, the Laboratory Response Network—an integrated net- work of state and local public health, federal, and military laboratories—provides diagnostic capacity to detect biological events and other PHEs across the United States. These networks allow rapid detectionandreportingofeventsat the state and federal levels for de- cision-making. Criteria could be developed that would escalate consideration for a PHE declara- tion (e.g., a confirmed Select Agent, outbreaks, events that meet the criteria for a potential PHE of International Concern under the International Health Regulations). This could possibly circumvent subjectivity in the assessment of whether an event exceeds state and local capacities, an issue that has plagued the Stafford Act declara- tion process.

The historical precedents that support state and local leader- ship in preparedness for and response to disasters are in many ways at odds with the technical demands of biological risk pre- paredness and response. New and revised laws and regulations,

executive orders, policies, strategies, and plans developed in response to biological threats since 2001 address the role of the federal government in the re- sponse to PHEs. However, fi- nancial mechanisms for disaster response—especially those that wait for gubernatorial request be- fore federal assistance is provided— do not align with the need to prevent the rapid spread of in- fectious agents. Ensuring that technicalandfinancialresourcescan be quickly mobilized does not necessarilydependondevelopment of new federal coordinating struc- tures, but on operationalizing existing mechanisms and capacities.

CONTRIBUTORS R. Katz and J.E. Fischer contributed to the conceptualization and design of this com- mentary. A. Attal-Juncqua conducted initial research and analysis. All authors contributed equally to the drafting of the article.

REFERENCES 1. Lister SA. Public health and medical emergency management: issues in the 112th Congress. 2011. CRS Report R41646. Available at: https://fas.org/ sgp/crs/misc/R41646.pdf. Accessed July 8, 2017.

2. Federal Emergency Management Agency. Disaster declarations. Available at: https://www.fema.gov/disasters. Accessed December 30, 2016.

3. Homeland Security Act, 116 Stat 2135 (2002).

4. Public Health Security and Bioterror- ism Preparedness and Response Act, 116 Stat 594 (2002).

5. The Pandemic and All Hazard Pre- paredness Act, 120 Stat 2831 (2006).

6. Federal Emergency Management Agency. National Response Framework. Dept of Homeland Security. 2016. Available at: https://www.fema.gov/ media-library-data/1466014682982- 9bcf8245ba4c60c120aa915abe74e15d/ National_Response_Framework3rd.pdf. Accessed July 14, 2017.

7. Federal Emergency Management Agency. Emergency Support Function #8—Public Health and Medical Services Annex. Dept of Homeland Security. 2016. Available at: https://www.fema.gov/ media-library-data/1470149644671- 642ccad05d19449d2d13b1b0952328ed/ ESF_8_Public_Health_Medical_ 20160705_508.pdf. Accessed July 14, 2017.

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8. Association of State and Territorial Health Officials. Emergency authority & immunity toolkit. Key federal laws and policies regarding emergency authority and immunity. Preparedness Series. 2016. Available at: http://www.astho.org/ Programs/Preparedness/Public-Health- Emergency-Law/Emergency-Authority- and-Immunity-Toolkit/Key-Federal- Laws-and-Policies-Regarding-Emergency- Authority-and-Immunity. Accessed July 15, 2016.

9. Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 USC 5170a, §402 (2013).

10. US Government Accountability Of- fice. Federal disaster assistance. September 2012. GAO-12–838. Available at: http:// www.gao.gov/assets/650/648162.pdf. Accessed December 20, 2016.

11. Federal Emergency Management Agency. FEMA disaster declarations summary—open government dataset. Available at: https://www.fema.gov/ media-library/assets/documents/28318. Accessed July 11, 2017.

12. Liu E. Would an influenza pandemic qualify as a major disaster under the Stafford Act? 2008. CRS Report RL34724. Available at: https://fas.org/ sgp/crs/misc/RL34724.pdf. Accessed July 8, 2017.

13. Swendiman KS, Jones NL. The 2009 influenza pandemic: selected legal issues. 2009. CRS Report R40560. Available at: http://research.policyarchive.org/19830. pdf. Accessed July 8, 2017.

14. National Emergencies Act, 50 USC §1601-1651 (1976).

15. Thronson P. Toward comprehensive reform of America’s emergency law re- gime. March 23, 2013. University of Michigan Journal of Law Reform, Vol. 46, No. 2. Available at: https://papers. ssrn.com/sol3/papers.cfm?abstract_ id=2056822. Accessed December 30, 2016.

16. The White House. Declaration of a national emergency with respect to the 2009 H1N1 influenza pandemic. October 24, 2009. Available at: https://babel. hathitrust.org/cgi/pt?id=mdp. 39015090373682;view=1up;seq=1. Accessed July 14, 2017.

17. Public Health Service Act, 42 USC §247d (2013).

18. US Dept of Health and Human Ser- vices. HHS declares a public health emergency in response to the Zika out- break. 2016. Available at: https://www. hhs.gov/about/news/2016/08/12/hhs- declares-public-health-emergency-in- puerto-rico-in-response-to-zika- outbreak.html. Accessed December 30, 2016.

19. Dept of Health and Human Services. FY2016 Public Health and Social Services Emergency Fund: Justification of

Estimates for Appropriations Committees. 2016. Available at: https://www.hhs. gov/sites/default/files/budget/fy2016/ fy2016-public-health-social-services- emergency-budget-justification.pdf. Accessed July 14, 2017.

20. Public Health Service Act Amend- ment, Public Health Emergency Fund, 42 USC 247d (1983).

21. Kates J, Michaud J, Wexler A, Valentine A. The US response to Ebola: status of the FY2015 Emergency Ebola Appropriation Global Health Policy. 2015. Available at: http://kff.org/global- health-policy/issue-brief/the-u-s- response-to-ebola-status-of-the-fy2015- emergency-ebola-appropriation. Accessed August 1, 2016, 2016.

22. Lindsey B. FEMA’s Disaster Relief Fund: overview and selected issues. 2014. CRS Report R43537. Available at: https://fas.org/sgp/crs/homesec/ R43537.pdf. Accessed July 8, 2017.

23. Dept of Homeland Security. Disaster Relief Fund: Monthly Report as of De- cember 31, 2015. 2016. Available at: https://www.dhs.gov/sites/default/files/ publications/FEMA%20-%20Disaster% 20Relief%20Fund%20-%20Monthly% 20Report%20-%20December%202015. pdf. Accessed July 14, 2017.

24. Sullivan P. Congress approves con- tinuing resolution, including $1.1 billion in Zika response funding. The Hill. 2016. Available at: http://thehill.com/policy/ healthcare/298394-congress-approves- 11b-in-zika-funds. Accessed July 12, 2017.

25. Centers for Disease Control and Prevention. November 2016 Zika case counts in the US. 2016. Available at: http://www.cdc.gov/zika/geo/united- states.html. Accessed November 17, 2016.

26. Supplemental Appropriation to the Public Health Emergency Fund, Public Health Emergency Preparedness Act, HR4525, 114th Cong (2015–2016).

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