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Frequently Asked Questions about
Federal Public Health Emergency Law

For this entire document, click here.

This report presents information in the form of "answers" to 37 questions about principal federal laws that shape response to public health emergencies. The information presented in this report is based on the April 28, 2009, teleconference "Federal Public Health Emergency Law: Implications for State & Local Preparedness and Response" and was compiled by the Public Health Law Program Centers for Disease Control and Prevention

The questions and answers are grouped into four categories: legal authorities, public health emergency procedures, isolation and quarantine, and workforce issues.

Editor: Emily McCormick, MPH, Prevention Specialist
Associate Editor: Montrece McNeill Ransom, JD, MPH, Senior Public Health Analyst
Contributing Editor: Stacie Kershner, JD, ORISE Fellow
CDC Public Health Law Program

Disclaimer:
The contents of this report have not been formally disseminated by the Centers for Disease Control and Prevention and should not be construed to represent any agency determination or policy. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. It is important to note that the contents of this document are for informational purposes only and are not intended to be a substitute for professional legal or other advice. While every effort has been made to verify the accuracy of these materials, legal authorities and requirements may vary across jurisdictions, and laws are often updated and amended. Always seek the advice of an attorney or other qualified professional with any questions you may have.

Legal Authorities

1.What authorities does the United States Department of Health and Human Services have in public health emergencies?
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2. What is the Stafford Act and how does it apply to public health emergencies?
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3. What is the purpose and function of the Pandemic and All-Hazards Preparedness Act?
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4. What is the Public Readiness and Emergency Preparedness (PREP) Act? What are current examples of declarations under the PREP Act?
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5. Who is covered by the PREP Act?
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6. What actions may the HHS Secretary take under Section 319 of the Public Health Service Act (PHSA) when a public health emergency has been declared?
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7. What other discretionary actions may the Secretary take once a public health emergency has been declared?
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8. What is an 1135 waiver?
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9. When the Secretary issues an 1135 waiver, what Medicare, Medicaid, CHIP, and HIPAA requirements may be temporarily waived or modified?

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Public Health Emergency Procedures

10. What is a public health emergency and how is a declaration of public health emergency made?
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11. May the Secretary declare a "potential" public health emergency?
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12. How does a public health emergency declaration relate to a Presidential declaration of an emergency or major disaster under the Stafford Act?
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13. What is a request for declaration?

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14. What is a Declaration of Primary Federal Responsibility?
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15. What types of Disaster Assistance are available?

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16. What is the role of the Federal Emergency Management Agency (FEMA) in public health emergencies?

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17. Is a public health emergency declaration required for HHS to provide assistance to states or localities?

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18. Is a declaration of public health emergency required for the Secretary to provide liability immunity under the PREP Act?

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19. Does a public health emergency declaration waive or preempt state licensing requirements for healthcare providers?

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20. Does a governor or other official have to make a formal request for a federal declaration of public health emergency or for an 1135 waiver?
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21. What is the Strategic National Stockpile (SNS)? How is it governed and deployed?
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22. Under what circumstances may investigational medications or products be used?
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Isolation and Quarantine

23. What are isolation and quarantine and when are such measures used?
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24. What is social distancing and what are some examples?
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25. What communicable diseases merit isolation or quarantine?
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26. What laws govern isolation and quarantine?
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27. What duties and obligations exist with respect to individuals under quarantine or isolation?
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28. What is CDC's role with respect to quarantine and isolation?
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29. How is quarantine and isolation enforced?
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Workforce Issues


30. Who are essential service providers and what access are they allowed during an emergency situation?
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31. For what purpose are personnel deployed by HHS in an emergency?

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32. What are the legal issues involved with deployment of personnel in the event of an emergency?

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33. What HHS personnel groups are eligible to be deployed in an emergency?
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34. What is the Commissioned Corps and how does it function?
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35. What is the Medical Reserve Corps and how does it function?
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36. What is the National Disaster Medical System (NDMS) and how does it function?
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37. How are healthcare providers who provide assistance during an emergency licensed and registered?
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International

Reports

Presentations



Glossary of Terms

ASP–Average Sales Price
ASPR–Assistant Secretary for Preparedness and Response
CHIP–Children's Health Insurance Program
CMS–Centers for Medicare and Medicaid Services
EMTALA–Emergency Medical Treatment and Active Labor Act
ESF–Emergency Support Function
ESAR-VHP–Emergency System for Advanced Registration of Volunteer Health Professionals
EUA–Emergency Use Authorization
FEMA–Federal Emergency Management Agency
FFDCA–Federal Food, Drug, and Cosmetic Act
HHS–United States Department of Health and Human Services
HIPAA–Health Insurance Portability and Accountability Act
NDMS–National Disaster Management System
PHSA–Public Health Service Act
PREP Act–Public Readiness and Emergency Preparedness Act
REMS–Risk Evaluation and Mitigation Strategies
SNS–Strategic National Stockpile
SSA–Social Security Act
USERRA–Uniform Services Employment and Re-Employment Rights Act

Introduction:

On April 26, 2009, the Acting Secretary of the federal Department of Health and Human Services (HHS) issued a nationwide public health emergency declaration in response to human infections from influenza A (H1N1) virus.  In addition, the World Health Organization raised the level of influenza pandemic alert to the highest level on June 11, 2009.  The HHS declaration was renewed by HHS Secretary Kathleen Sebelius on July 24, 2009.

Local and state health agencies are the first line of preparedness for infectious disease pandemics and other threats to the health of the public.  Their success hinges on many factors, including, their "legal preparedness," that is, their understanding of and capacity to use, laws and legal authorities that support effective response.  Those legal authorities are complex and involve laws at the federal, state, local, and Tribal levels.  Further, they are found in multiple sectors, including not only the public health sector but also such sectors as emergency management, health care, law enforcement, education, and transportation.

Because a number of federal laws relevant to public health emergencies had been revised in recent years, in the spring of 2009 CDC's Public Health Law Program and invited four senior federal attorneys to update public health practitioners and counsel on current, pertinent federal laws in a 90-minute teleconference on April 28, 2009.  By coincidence, the teleconference "Federal Public Health Emergency Law: Implications for State and Local Preparedness and Response" took place at the beginning of a novel influenza A (H1N1) pandemic. The faculty highlighted provisions of federal law especially relevant to that new threat.  Following the presentation, members of the large audience – more than 1,300 public health and other professionals – focused many of their questions on issues related to the pandemic.

This report – Frequently Asked Questions about Federal Public Health Emergency Law – is derived from the April 28 program and the dialogue between the faculty and participants that followed.  The questions and answers are organized in four categories: legal authorities, public health emergency procedures, isolation and quarantine issues, and workforce issues.

Although the contents of this report were reviewed by the faculty, it is a product of the CDC Public Health Law Program and the Program takes responsibility for any errors it may contain.  To view the entire April 28 presentation and access the transcript, please visit http://www2a.cdc.gov/phlp/webinar_04_29_2009.asp.
 

The teleconference faculty included:

  • Susan Sherman, JD, MHS, and Jennifer Ray, JD, MPH, Office of the General Counsel, U.S. Department of Health and Human Services
  • Diane Donley, JD, Office of Chief Counsel, Federal Emergency Management Agency, U.S. Department of Homeland Security; and
  • Kim Dammers, JD, Assistant U.S. Attorney, Northern District of Georgia, U.S. Department of Justice, at the time on detail to CDC.

The CDC Public Health Law Program is grateful to the faculty and to Brian Kamoie, JD, MPH, Deputy Assistant Secretary and Director, Office of Policy, Strategic Planning and Communications, Office of the Assistant Secretary for Preparedness and Response, HHS, who introduced the program.

The CDC Public Health Law Program provides many additional resources on public health emergency legal preparedness accessible in the "CDC Public Health Emergency Legal Preparedness Clearinghouse" at http://www.cdc.gov/phlp:

·        Up-to-date information on legal issues and resources related to infectious disease outbreaks

·        The training curricula Public Health Emergency Law 3.0 and Forensic Epidemiology 3.0

·        The Social Distancing Law Assessment Template

·        The Menu of Suggested Provisions for Public Health Mutual Aid Agreements and companion Inventory of Mutual Aid Agreements and Related Provision"

·        A three-part portfolio of resources for improved coordination across public health, law enforcement, the judiciary, and the corrections sector, and

·        The National Action Agenda for Public Health Legal Preparedness

The Program also publishes the monthly CDC Public Health Law News, a digest of developments in public health law and guide to new resources for improved public health legal preparedness.  Subscribe at the CDC Public Health Law News Web site (http://www2a.cdc.gov/phlp/cphln.asp).

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