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Frequently Asked
Questions about
Federal Public Health Emergency Law
Introduction
FAQs
Glossary
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.
FAQs
1.What authorities does the United States Department of Health
and Human Services have in public health emergencies?
Answer [ +]
Primarily, HHS authorities flow from the Public Health Service
Act (PHSA) that was enacted in 1944 and has been amended many
times since then. According to the PHSA, the Secretary of HHS
“shall lead all Federal public health and medical response to
public health emergencies and incidents covered by the National
Response [Framework].” HHS is the primary agency for Emergency
Support Function (ESF) 8 under the National Response Framework,
which covers public health and medical response. HHS is also
a support agency for ESF 6, covering mass care, emergency assistance,
housing, and human services. Section 311 of the PHSA provides
the Secretary of HHS with authority to extend temporary assistance
to states or localities to meet health emergencies at the request
of states or local authorities, including utilizing HHS personnel,
equipment, medical supplies and other resources, when state
resources are overwhelmed by an emergency situation. HHS also
requires funding and resources to respond to other emergency
events.
While Section 311 gives HHS broad authority to assist a state
or locality during an emergency, if a Stafford Act declaration
is issued by the President, HHS would generally do so under
a Mission Assignment from FEMA. The Secretary may authorize
assistance regardless of a formal declaration of a public health
emergency or a Stafford Act declaration. Additional authority
comes from the Federal Food, Drug, and Cosmetic Act when relevant
to emergency response as well as Social Security Act authorities.
2. What is the Stafford Act and how does it apply to public health
emergencies?
Answer [ +]
In 1950, the first public law was passed creating a federal
disaster relief program. The Robert T. Stafford Disaster Relief
and Emergency Assistance Act (The Stafford Act), amending the
Disaster Relief Act of 1974, was passed in 1988 and functions
as one of the primary disaster relief legal authorities. The
Stafford Act authorizes the President to issue a major disaster
or an emergency declaration in response to an event (or threat)
that overwhelms state or local government. The governor of an
affected state must first respond to the disaster and execute
the state’s emergency plan before requesting that the President
declare a major disaster or emergency and the governor must
certify that the magnitude of the emergency exceeds the state’s
capability. Declaration under the Stafford Act triggers access
to disaster relief funds as appropriated by Congress. The fund
has several billion dollars to be immediately available for
the emergency needs of states and local governments. The Stafford
Act also authorizes the Federal Emergency Management Agency
(FEMA) to coordinate administering all of the disaster relief
to the states.
3. What is the purpose and function of the Pandemic and All-Hazards
Preparedness Act?
Answer [ +]
The Pandemic and All-Hazards Preparedness Act passed in 2006
amends the PHSA and identifies the Secretary of HHS as the lead
federal official for public health emergency preparedness and
response and also establishes the HHS Assistant Secretary for
Preparedness and Response (ASPR). The ASPR serves as the Secretary
of HHS’s principle advisor on matters related to public health
and medical emergency preparedness. The act also provides new
authorities for development of countermeasures and establishes
mechanisms and grants to continue strengthening of state and
local public health security infrastructure and addresses surge
capacity by placing the National Disaster Medical System under
the purview of HHS.
4. What is the Public Readiness and Emergency Preparedness (PREP)
Act? What are current examples of declarations under the PREP Act?
Answer [ +]
The PREP Act authorizes the Secretary to issue a declaration
to provide immunity from tort liability (except for willful
misconduct) for claims
- Of death; physical, mental, emotional injury, illness,
disability, condition or fear thereof, including medical
monitoring, property damage, loss, including business interruption
loss
- Causally related to administration or use of “covered
countermeasures” including design, development, clinical
testing or investigation, manufacture, labeling, distribution,
formulation, packaging, marketing, promotion, sale, purchase,
donation, dispensing, prescribing, administration, licensing,
or use
- Against “covered persons”
The PREP Act also authorizes an emergency fund in the United
States Treasury for compensation for injuries from covered countermeasures
used and administered under a declaration issued by the Secretary
under the PREP Act.
Covered countermeasures include security countermeasures against
biological, chemical, radiological, or nuclear threats and qualified
pandemic and epidemic products, including drugs, biological
products (including vaccines), or devices that are licensed,
approved, or cleared by the Federal Food and Drug Administration,
authorized for emergency use by the FDA under section 564 of
the Federal Food, Drug, and Cosmetic Act (FFDCA), or authorized
for investigational use by the FDA.
To make a declaration under this act, the statute requires that
the Secretary consider the desirability of encouraging design,
development, clinical testing, investigation, manufacturer labeling,
and any additional factors relevant to creating a countermeasure.
The Secretary has to determine that a disease, health condition,
or threat to health, constitutes a public health emergency or
a credible risk of future public health emergency.
The PREP Act declarations are designed to encourage manufacturers
to develop countermeasures during public health emergencies
knowing that they will be protected from liability. Current
PREP Act declarations include.
- Pandemic Influenza Vaccines, 72 Fed. Reg. 4710, 67731
73 Fed. Reg. 61871, 74 Fed. Reg. 30294
- Pandemic Influenza Antivirals, 73 Fed. Reg. 61861, 74
Fed. Reg. 29213
- Anthrax Countermeasures, 73 Fed. Reg. 58239
- Botulinum Toxin Countermeasures, 73 Fed. Reg. 61864
- Acute Radiation Countermeasures, 73 Fed. Reg. 61866
- Smallpox Countermeasures, 73 Fed. Reg. 61689
- Pandemic Influenza Diagnostics, Personal Respiratory
Protection Devices, and Respiratory Support Devices, 73
Fed. Reg. 78362
[ +]
The PREP Act provides liability immunity coverage for the United
States, manufacturers, distributors, program planners (state,
local and tribal government as well as others who supervise
or administer countermeasure programs), qualified persons (licensed
health professionals and others identified by the Secretary
who prescribe, administer, or dispense countermeasures), and
officials, agents, employees of all of those mentioned.
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?
Answer [ +]
Under Section 319 of the PHSA, when the Secretary has declared
a public health emergency, the Secretary can take appropriate
actions consistent with her other authorities to respond to
the public health emergency, including making grants; entering
into contracts; and investigating the cause, treatment, or prevention
of the disease or disorder. In addition, the Secretary may access
the Public Health Emergency Fund appropriated by Congress (although
currently there are no funds appropriated to this fund).
7. What other discretionary actions may the Secretary take once
a public health emergency has been declared?
Answer [ +]
Certain authorities have been added to the PHSA; the Social
Security Act (SSA); the Federal Food, Drug, and Cosmetic Act
(FFDCA); and other laws administered by the Secretary that permit
him or her to take certain discretionary actions when he or
she has declared a public health emergency under Section 319
of the PHSA.
For example, the Secretary may:
- Waive or modify certain requirements: Under Section
1135 of the SSA, the Secretary may waive or modify certain
requirements of Medicare, Medicaid, State Children’s Health
Insurance Program (CHIP) and Health Insurance Portability
and Accountability Act (HIPAA) as necessary to ensure that
sufficient health care items and services are available
to meet the needs of individuals enrolled in SSA programs
and that providers of such services in good faith who are
unable to comply with certain statutory requirements are
reimbursed and exempted from sanctions for noncompliance,
absent fraud or abuse.
- Exempt for 30 days a person from select agents requirements:
as necessary to provide for timely participation of the
entity in a response to a domestic or foreign public health
emergency that involves the select agent or toxin. HHS and
USDA published final rules (7 CFR 331, 9 CFR 121, and 42
CFR 73), which implement the provisions of the Public Health
Security and Bioterrorism Preparedness and Response Act
of 2002 (Public Law 107-188) setting forth the requirements
for possession, use, and transfer of select agents and toxins.
- Waive certain prescription and dispensing requirements:
Under Section 505-1(f) of the Federal Food, Drug, and Cosmetic
Act (FFDCA), the Food and Drug Administration (FDA) has
the authority to require Risk Evaluation and Mitigation
Strategies (REMS) for a prescription drug as necessary to
assure safe use of the drug, because of its inherent toxicity
or potential harmfulness, if FDA determines that the drug
is effective but is associated with a serious adverse drug
experience, and could not be approved (or approval would
be withdrawn) without the required elements to mitigate
the risk and other potential REMS elements are not sufficient
to mitigate the risk.
- Adjust Medicare reimbursement for certain Part B
drug: In the case of a public health emergency in which
there is a documented inability to access drugs and biologicals
and a associated increase in the price of a drug or biological
that is not reflected in the manufacturer’s average sales
price (ASP) for one or more quarters, the Secretary may
use the wholesale acquisition cost or other reasonable measure
of drug or biological price instead of the manufacturer’s
ASP. The substituted price or measure may be used until
the price of the drug or biological has stabilized and is
substantially reflected in the manufacturer’s ASP.
- Waive certain Ryan White HIV/AIDS grant program requirements:
Under Section 2683 of the PHSA, up to five percent of the
funds available under each of the Parts A and B base supplemental
pools may be shifted to ensure access to care during the
time period when the Secretary declares a public health
emergency or when the President declares an emergency or
major disaster under the Stafford Act or the National Emergencies
Act.
- Make temporary appointments: The Secretary may
make temporary (up to one year or the duration of the emergency)
appointments of personnel to positions that directly respond
to the public health emergency when the urgency of filling
positions prohibits examining applicants through the competitive
process.
- Declare an emergency justifying an emergency use
authorization (EUA): Under Section 564 of the FFDCA,
the Secretary can declare an emergency that justifies an
EUA that allows for the use of unapproved drugs, devices,
or biological products, or for the use of approved drugs,
devices, or biological products for a not yet approved purpose.
[ +]
Section 1135 waivers are authorized by the Social Security Act
and are applicable only in the ‘emergency area’ during the ‘emergency
period’ as outlined in the declarations. An emergency area and
period is where and when there is: a) an emergency or disaster
declared by the President pursuant to the National Emergencies
Act or the Stafford Act, and b) a public health emergency declared
by the Secretary. The waiver lists types of requirements that
can be waived or modified to assist states in providing surge
capacity such as waiver or modification of bed limits for critical
access hospitals. When the Secretary issues an 1135 waiver,
hospitals and other entities usually work with HHS Regional
Centers for Medicare and Medicaid Services (CMS) officials to
seek specific waivers or modifications on a case-by-case basis.
Certain Emergency Medical Treatment and Labor Act (EMTALA) sanctions
and Health Insurance Portability and Accountability Act (HIPAA)
sanctions that can be waived for just a short time. This is
not a waiver of HIPAA in its entirety. The waiver of HIPAA sanctions
and non-pandemic infectious disease related waivers of sanctions
under EMTALA are limited to a 72 hour period beginning upon
implementation of a hospital disaster protocol.
9. When the Secretary issues an 1135 waiver, what Medicare, Medicaid,
CHIP, and HIPAA requirements may be temporarily waived or modified?
Answer [ +]
Under Section 1135, the following Medicare, Medicaid, CHIP and
HIPAA requirements may be waived or modified:
- Conditions of participation or other certification requirements,
or program participation and similar requirements for individual
providers or types of providers.
- Pre-approval requirements for providers or health care
items or services.
- Requirements that physicians and other health care professionals
hold licenses in the state in which they provide services
if they have a license from another state and are not affirmatively
barred from practice in that state or any state in the emergency
area (note however, that this waiver is for the purposes
of Medicare, Medicaid, and CHIP reimbursement only – states
determine whether a non-federal provider is authorized to
provide services in the state without state licensure).
- Sanctions under EMTALA for redirection of an individual
to another location to receive a medical screening examination
pursuant to a state emergency preparedness plan, or in the
case of a public health emergency involving a pandemic infectious
disease, a state pandemic preparedness plan, or for transfer
of an individual who has not been stabilized if the transfer
is necessitated by the circumstances of the emergency. A
waiver of EMTALA sanctions is effective only if actions
under the waiver do not discriminate on the basis of a patient’s
source of payment or ability to pay. EMTALA waivers are
subject to special time limits.
- Sanctions related to stark self-referral prohibitions
that could apply when a physician refers a patient for services
to a provider with whom the physician has a financial interest.
- Deadlines and time tables for performing required activities
to allow timing of such deadlines to be modified.
- Limitations on payments to permit Medicare Advantage
Choice enrollees to use out-of-network providers in an emergency
situation. To the extent possible, the Secretary must reconcile
payments so that enrollees do not pay additional charges
and so that the plan pays for services included in the capitation
payment.
- Sanctions and penalties arising from noncompliance with
HIPAA privacy regulations relating to: a) obtaining a patient’s
agreement to speak with family members or friends or honoring
a patient’s request to opt out of the facility directory,
b) distributing a notice of privacy practices, or c) the
patient’s right to request privacy restrictions or confidential
communications. The waiver of HIPAA requirements is effective
only if actions under the waiver do not discriminate on
the basis of a patient’s source of payment or ability to
pay. These HIPAA waivers under are subject to special time
limits.
Medicare, Medicaid, and CHIP requirements are not automatically
waived or modified by the issuance of an 1135 waiver. Rather,
the Centers for Medicare & Medicaid Services (CMS) receive requests
from affected hospitals, health care facilities, and health
care providers for waivers or modifications of specific requirements
and issues instructions or guidance as needed. CMS reviews such
requests and generally approves the requested waivers or modifications
on a case-by-case basis. Regardless of whether the Secretary
has made a formal public health emergency declaration under
Section 319 of the PHSA, and even in the absence of an 1135
waiver, other SSA provisions and CMS regulations may provide
certain flexibilities that may be implemented as appropriate
to address an emergency or disaster. CMS works closely with
affected hospitals, health care facilities, and health care
providers during such situations to address their concerns.
When the Secretary issues an 1135 waiver, HHS automatically
waives such sanctions and penalties described in the 1135 waiver
in the emergency area for 72 hours beginning when a hospital
disaster protocol is implemented. The waiver of HIPAA requirements
is effective only if actions under the waiver do not discriminate
on the basis of a patient’s source of payment or ability to
pay. Also, the waiver only applies if the hospital has implemented
its hospital disaster protocol. The HIPAA sanctions and penalties
that may be waived when an 1135 waiver is issued are specified
in the 1135 waiver document and do not waive HIPAA in its entirety.
Even without an 1135 waiver, there are various flexibilities
and exceptions that may apply to permit covered entities to
share protected health information during a public health emergency.
See the HHS Web page Emergency Preparedness Planning and Response
( http://www.HHS.gov/ocr/hipaa/emergencyPPR.html)
for more information about the application of HIPAA during public
health emergencies (whether or not the Secretary makes a formal
public health emergency declaration under section 319 of the
PHSA, or issues an 1135 waiver).
Waivers or modifications under section 1135 of the SSA may be
retroactive to the beginning of the emergency period (or to
any subsequent date). The waiver or modification terminates
either upon termination of the emergency period or 60 days after
the waiver or modification is first published (subject to 60-day
renewal periods until termination of the emergency). However,
waivers of EMTALA (except in the case of a pandemic disease)
or HIPAA requirements are effective only for 72 hours beginning
on implementation of a hospital disaster protocol. A waiver
of EMTALA sanctions in connection with an emergency involving
a pandemic disease (such as pandemic influenza) is effective
until the termination of the pandemic-related public health
emergency. However, a particular waiver or modification will
terminate prior to the ultimate termination date described in
this paragraph (e.g., prior to the 72 hour time period after
a hospital begins to implement its disaster protocol) if the
Secretary determines that as of an earlier date, the waiver
or modification is no longer necessary to accomplish the purposes
set forth in Section 1135(a).
10. What is a public health emergency and how is a declaration
of public health emergency made?
Answer [ +]
Under Section 319 of the Public Health Services Act (42 U.S.C.
§ 247d), the Secretary may declare a public health emergency
if the Secretary determines, after consultation with such public
health officials as may be necessary, that “(1) a disease or
disorder presents a public health emergency; or (2) a public
health emergency, including significant outbreaks of infectious
diseases or bioterrorist attacks, otherwise exists.” The broad
definition gives HHS discretion to determine if a particular
event constitutes a public health emergency. A public health
emergency declaration lasts for 90 days and can be terminated
earlier if the Secretary determines the emergency no longer
exists. It can also be renewed by the Secretary for additional
90 day periods if the emergency continues to exist.
11. May the Secretary declare a “potential” public health emergency?
Answer [ +]
The Secretary has the discretion to determine that a disease
or condition presents a public health emergency, or a public
health emergency otherwise exists, based on conditions that
exist prior to the actual outbreak of disease or natural catastrophe.
For example, the Secretary may declare a public health emergency
based on emergency needs that exist preceding the outbreak of
disease or in anticipation of a storm before a hurricane makes
landfall. The statutory language in section 319 of the PHSA,
however, does not explicitly use the term “potential” public
health emergency.
12. How does a public health emergency declaration relate to
a Presidential declaration of an emergency or major disaster under
the Stafford Act?
Answer [ +]
A public health emergency declaration under Section 319 of the
PHSA and a Presidential declaration of an emergency or disaster
under the Stafford Act are distinct and separate declarations.
When an incident overwhelms or is anticipated to overwhelm State
resources, the Governor may request federal assistance, including
assistance under the Stafford Act. The Stafford Act authorizes
the President to provide financial and other assistance to State
and local governments, certain private nonprofit organizations,
and individuals to support response, recovery, and mitigation
efforts following Presidential emergency or disaster declarations.
The Stafford Act is triggered by a Presidential declaration
of a major disaster or emergency, when an event causes damages
of sufficient severity and magnitude to warrant federal disaster
assistance to supplement the efforts and available resources
of States, local governments, and the disaster relief organizations
in alleviating the damage, loss, hardship, or suffering. Most
incidents are not of sufficient magnitude to warrant a Presidential
declaration. However, if State and local resources are insufficient,
a Governor may ask the President to make such a declaration.
Ordinarily only a Governor can initiate a request for a Presidential
emergency or major disaster declaration. In extraordinary circumstances,
the President may unilaterally declare a major disaster or emergency.
Unlike a Presidential declaration of a major disaster or emergency
under the Stafford Act which ordinarily requires a formal request
by a state Governor, there is no requirement that a Governor
or other entity make a formal request in order for the Secretary
to declare a public health emergency under section 319 of the
PHSA. The President may declare a major disaster or emergency
under the Stafford Act in the absence of a Secretarial declaration
of a public health emergency under section 319 of the PHSA.
Likewise, the Secretary of HHS may declare a public health emergency
under section 319 of the PHSA in the absence of a Presidential
declaration under the Stafford Act.
While a Presidential declaration under the Stafford Act and
a Secretarial declaration of a public health emergency are separate
declarations, sometimes a Stafford Act declaration is required
in order for the Secretary to exercise certain authorities.
For example, in order for the Secretary to exercise his waiver
authority under section 1135 of the SSA to temporarily waive
or modify certain Medicare, Medicaid, CHIP, and HIPAA requirements,
there must be a public health emergency declaration in place,
as well as a Presidential declaration of a major disaster or
emergency pursuant to the Stafford Act (or the National Emergencies
Act).
13. What is a request for declaration?
Answer [ +]
A governor may request the President declare a major disaster
or emergency, following execution of the state's emergency plan.
The President may make this declaration if the governor certifies
in writing that the severity and magnitude of the emergency
is beyond the capability of the state justifying the need for
federal assistance.
14. What is a Declaration of Primary Federal Responsibility?
Answer [ +]
The President may declare an emergency without the request of
a governor if the emergency involves “federal primary responsibility”
(such as if the event occurs on federal property, for example
the bombing of the Murrah Federal Building in 1995). Alternatively,
the President may issue a declaration of federal primary responsibility
for public health issues that are a joint state and federal
responsibility and not primarily federal responsibility.
15. What types of Disaster Assistance are available?
Answer [ +]
Disaster assistance programs are grouped into three categories:
public assistance, individual assistance and hazard mitigation.
Public assistance includes emergency work and permanent work
to assist states, local governments, and certain private non-profits.
Funding for public assistance is divided into either a 75% federal
share/25% state share or as dictated by the President. Disaster
assistance program activities are frequently executed by FEMA
in the form of Mission Assignments or are contracted to a support
agency and managed by FEMA. Individual assistance may occur
immediately following an emergency event and is limited to $30,000
per person for direct financial assistance for housing and other
disaster-related needs. Hazard mitigation assists state and
local governments to decrease the loss of life and property
due to natural disasters and enables measures to be implemented
quickly when beginning recovery activity.
16. What is the role of the Federal Emergency Management Agency
(FEMA) in public health emergencies?
Answer [ +]
The Homeland Security Act was passed in 2002 and moved FEMA,
a previously independent agency, to the Department of Homeland
Security where it is today. In response to Hurricane Katrina,
the Post Katrina Emergency Management Reform Act was passed
on October 4, 2006 changing FEMA’s authority and mission. The
updated mission of FEMA is “to reduce the loss of life and property
and protect the Nation from all hazards, including natural disasters,
acts of terrorism, and other man-made disasters, by leading
and supporting the Nation in a risk-based, comprehensive emergency
management system of preparedness, protection, response, recovery,
and mitigation.” FEMA works with state, local, and tribal governments,
emergency response providers, other federal agencies, and the
private sector.
17. Is a public health emergency declaration required for HHS to
provide assistance to states or localities?
Answer [ +]
Even without a public health emergency declaration, the Secretary
has broad legal authority to provide assistance to states and
to conduct research studies. For example, under Section 301
of the PHSA, the Secretary has broad authority to render assistance
and promote research, investigations, demonstrations, and studies
into the causes, diagnosis, treatment, control, and prevention
of physical and mental diseases and impairments of man. Similarly,
under Section 311 of the PHSA, the Secretary is authorized to
assist states and their political subdivisions in the prevention
and suppression of communicable diseases and to develop and
take necessary actions to implement a plan under which personnel,
equipment, medical supplies, and other resources of the Public
Health Service and other agencies under the jurisdiction of
the Secretary may be effectively used to control the epidemics
of any disease or condition and to meet other health emergencies
or problems. The Secretary may also activate the National Disaster
Medical System and deploy the Strategic National Stockpile without
a public health emergency declaration.
18. Is a declaration of public health emergency required for the
Secretary to provide liability immunity under the PREP Act?
Answer [ +]
Under the PREP Act, Pub. L. No. 109-148, the Secretary may issue
a declaration that provides tort liability immunity (except
for willful misconduct) for claims of loss caused, arising out
of, relating, to, or resulting from administration and use of
countermeasures to diseases, threats and conditions determined
by the Secretary to constitute a present, or credible risk of
a future public health emergency to entities and individuals
involved in the development, manufacture, testing, distribution,
administration, and use of such countermeasures. A PREP Act
declaration is independent of a public health emergency declaration,
and the Secretary does not have to declare a public health emergency
to issue a PREP Act declaration or for liability immunity under
the PREP Act to take effect. For more information about the
PREP Act, please visit the PREP Act site at:
http://www.HHS.gov/disasters/emergency/manmadedisasters/bioterorism/medication-vaccine-qa.html.
19. Does a public health emergency declaration waive or preempt
state licensing requirements for healthcare providers?
Answer [ +]
A public health emergency declaration does not waive or preempt
state licensing requirements. States determine whether and under
what circumstances a non-federal healthcare provider is authorized
to provide services in the state without state licensure.
As discussed above, when the Secretary issues an 1135 waiver,
the Secretary may waive Medicare, Medicaid or CHIP requirements
that physicians and other health care professionals hold licenses
in the State in which they provide services. This would be for
Medicare, Medicaid or CHIP reimbursement purposes only, and
would apply only if the physicians or other health care providers
have an equivalent license from another State (and are not affirmatively
barred from practice in any State in the emergency area).
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?
Answer [ +]
There is no requirement under Section 319 of the PHSA, or under
Section 1135 of the SSA that a state or other entity make a
formal request for a public health emergency declaration or
an 1135 waiver. When state or local officials believe that a
public health emergency declaration and 1135 waivers are needed
to assist the response to a particular event, HHS encourages
them to work with the HHS Regional Emergency Coordinator at
the HHS regional office in their area who can help facilitate
the request. Hospitals, healthcare entities, and health care
providers who have concerns about Medicare, Medicaid, and CHIP
requirements should contact the Centers for Medicaid & Medicare
Services (CMS) regional office in their area who can help address
such concerns.
21. What is the Strategic National Stockpile (SNS)? How is it
governed and deployed?
Answer [ +]
Under 42 U.S.C. § 247d-6b, the HHS Secretary, in coordination
with the Secretary of Homeland Security, and in consultation
with the CDC Director, maintains a stockpile of drugs, vaccines,
and other biological products, as well as medical devices and
other supplies in such numbers, types, and amounts as determined
by the Secretary of HHS to be appropriate and practicable to
provide for the emergency health security of the United States,
including the emergency health security of children and other
vulnerable populations. ASPR exercises the responsibilities
and authorities of the Secretary with respect to coordination
of the Strategic National Stockpile.
Items in the SNS can be deployed by the Secretary of Homeland
Security to respond to an actual or potential emergency or by
the HHS Secretary to respond to an actual or potential public
health emergency or other situation in which deployment is necessary
to protect public health and safety. The declaration of a public
health emergency is not required to deploy the stockpile and
contents can be deployed in advance of a public health emergency.
22. Under what circumstances may investigational medications
or products be used?
Answer [ +]
Under the Project Bioshield Act, if the HHS Secretary has declared
a public health emergency, the Secretary of Homeland Security
has declared an actual or significant potential for a domestic
emergency, or the Secretary of Defense has declared actual or
significant potential for heightened risk to the military, the
FDA may issue an Emergency Use Authorization (EUA) to allow
for use of unapproved new drugs, off label use of drugs approved
for other purposes, unlicensed biological products, or medical
devices not yet approved when responding to the emergency. The
EUA expires when the declaration of emergency terminates or
when authorization is revoked. The FDA Commissioner may impose
conditions on the use of the drug or device. All declarations
and EUA documents are published in the federal register.
23. What are isolation and quarantine and when are such measures
used?
Answer [ +]
Isolation is used to separate and restrict movement of
ill persons found to be infected with a quarantinable disease
from those who are healthy to prevent the spread of the quarantinable
disease. For examples, hospitals use isolation for patients
with infectious tuberculosis.
Quarantine is used to separate and restrict the movement
of a well person who does not show signs of illness, but is
reasonably believed to have been exposed to the infectious agent
that causes a quarantinable disease. These people may have been
exposed to a communicable disease and not know it, or they may
have the communicable disease but do not show symptoms. Both
quarantine and isolation are used to help limit the spread of
communicable diseases.
24. What is social distancing and what are some examples?
Answer [ +]
Social distancing measures decrease the transmission or spread
of an outbreak in a population by limiting social interaction.
Social distancing measures can include, for example, school
and daycare center closures, cancelation of large public gatherings
(e.g., concerts, theaters), limitations for other public contacts
(e.g., markets, public transit), and quarantine, among others.
These measures can increase the efficacy of other public health
interventions, such as vaccination.
25. What communicable diseases merit isolation or quarantine?
Answer [ +]
States have laws that authorize quarantine and isolation to
control the spread of communicable diseases based on the state’s
police power authority to protect the health, safety, and welfare
of its citizens. These laws can vary from state to state and
can be broad or specific. In some states, local health authorities
are empowered to implement quarantine and isolation based on
state law.
Federal quarantine and isolation authority is limited, to those
communicable diseases specified in an executive order of the
President, i.e., “quarantinable diseases”. The most current
list is found in Executive Order 13295, as amended by Executive
Order 13375. These quarantinable diseases include cholera; diphtheria;
infectious tuberculosis; plague; smallpox; yellow fever; viral
hemorrhagic fevers; severe acute respiratory syndrome (SARS),
and influenza caused by novel or reemerging influenza viruses
that are causing, or have the potential to cause, a pandemic.
26. What laws govern isolation and quarantine?
Answer [ +]
Under section 361 of the Public Health Service Act, CDC may
apprehend, examine, detain, or conditionally release persons
with certain communicable diseases that are listed in an Executive
Order of the President, i.e., “quarantinable diseases.” This
includes the authority to quarantine and isolate persons to
prevent the spread of these diseases. (42 U.S.C. § 264),
Also under 42 U.S.C. § 264, CDC may apprehend and examine individuals
traveling from one state into another if the CDC Director reasonably
believes that such individuals may be infected with a quarantinable
disease in its qualifying stage. A qualifying stage means that
the disease is in a communicable stage, or a pre-communicable
stage, but only if the disease would be likely to cause a public
health emergency if transmitted to other individuals. Additionally,
the Director must reasonably believe that the individual is
moving or about to move from one state into another or constitutes
a probable source of infection to other individuals, who while
infected with such disease in its qualifying stage, will be
moving from one state into another. If such individuals are
found to be infected, they may be detained as reasonably necessary.
Federal regulations governing quarantine and isolation are found
in the Code of Federal Regulations at 42 CFR parts 70 and 71.
Part 70 governs interstate quarantine and isolation, while part
71 deals with foreign quarantine and isolation. In November,
2005, CDC proposed revisions to its federal regulations governing
quarantine and isolation. At the time of publication of this
report, the final quarantine regulations were expected to be
published in the near future.
27. What duties and obligations exist with respect to individuals
under quarantine or isolation?
Answer [ +]
It is well recognized that freedom from physical restraint is
a liberty interest protected by the due process clauses of the
Fifth and Fourteenth amendments to the United States Constitution.
In general, due process includes the following elements: reasonable
and adequate notice of the action that the government is taking,
typically through a written order; an opportunity to be heard
on a timely basis, typically through some form of hearing or
other proceeding; access to legal counsel; and review of the
government’s actions by an impartial decision-maker.
28. What is CDC’s role with respect to quarantine and isolation?
Answer [ +]
States have primary responsibility for controlling the spread
of communicable diseases within their borders. CDC serves a
primary role for controlling the introduction, transmission,
and spread of communicable diseases at United States ports of
entry. For example, when alerted about an ill passenger or crewmember
by a pilot of a plane or captain of a ship, CDC may briefly
detain the conveyance for purposes of investigating the cause
of the illness onboard and to determine whether it may be communicable.
In recent history, only a few public health events have prompted
federal isolation or quarantine orders.
29. How is quarantine and isolation enforced?
Answer [ +]
Public health authorities at the federal, state, or local level
may sometimes seek help from police or other law enforcement
officers to enforce a public health order. Under the Public
Health Service Act, United States Customs and Border Protection
(CBP) and the United States Coast Guard (USCG) are required
to assist CDC in enforcing its quarantine regulations. In most
jurisdictions, violating a quarantine or isolation order is
punishable by fines and/or imprisonment.
30. Who are essential service providers and what access are they
allowed during an emergency situation?
Answer [ +]
According to Section 427 of the Stafford Act (42 U.S.C. 5189e),
the head of a federal agency “may not deny or impede access
to the disaster site to an essential service provider whose
is necessary to restore and repair an essential service.” Essential
service providers include municipal, nonprofit, or private for-profit
entities that provide telecommunications service, electrical
power, natural gas, water and sewer services or any other essential
service as determined by the President.
31. For what purpose are personnel deployed by HHS in an emergency?
Answer [ +]
Personnel are deployed to provide medical surge for activities
such as sheltering, patient collection, patient evacuation,
case management, epidemiologic investigations, and operating
federal medical stations.
32. What are the legal issues involved with deployment of personnel
in the event of an emergency?
Answer [ +]
When healthcare personnel are deployed across state lines, licensing,
workers compensation, and liability concerns may arise. At the
state and federal levels, liability and licensure are covered
by a patchwork of different sources, some of which are addressed
here.
The Federal Tort Claims Act (FTCA), (28 USC 2672 and 1346(b)),
provides that the United States shall be liable for the negligence
of its officers and employees while acting within the scope
of their employment, in the same manner as a private person
would be liable to a claimant under the laws of the state where
the injury occurred. In other words, the FTCA covers claims
for property damage or personal injury or death caused by the
negligence, wrongful act, or omission of a federal employee
acting within the scope of his/her employment. The FTCA coverage
applies as long as the act is considered part of the employee's
official duties and the action in question is within the scope
of employment. Obviously, therefore, the FTCA would not apply
to any activities undertaken outside of the employee's official
duties as a federal employee. The FTCA, however, does not provide
relief to all claims arising out of the actions of government
employees acting in the scope of employment. Exceptions to the
FTCA, provided in 28 U.S.C. § 2680, include, for example, any
claim arising in a foreign country. (28 U.S.C. §2860(k))
The Federal Employees' Compensation Act (FECA, 5 USC 8101 et
seq.), provides compensation benefits to civilian employees
of the United States for disability due to personal injury sustained
by the employee while in the performance of work-related duties.
In other words, for example, if a federal employee sustains
an injury to himself/herself while operating his/her own personal
vehicle in the course of business/scope of employment, FECA
would apply. Benefits will not be paid, however, if the injury
is caused by the willful misconduct of the employee or by the
employee's intention to bring about his or her injury, or if
intoxication (by alcohol or drugs) is the proximate cause of
the injury.
Many states have provisions for some sort of liability protection
for healthcare providers. State Good Samaritan statutes may
offer liability protection to healthcare workers but differ
by states in terms of breath of coverage. The Federal Volunteer
Protection Act and certain state volunteer protection acts may
provide liability protection for healthcare providers. The Emergency
Management Assistance Compact (EMAC), of which all states are
members, provides immunity to state officers and employees that
other states share with an affected state pursuant to the compact.
The Uniform Emergency Volunteer Health Practitioners Acts is
a model law that addresses liability and licensing and has been
adopted by ten states thus far.
33. What HHS personnel groups are eligible to be deployed in
an emergency?
Answer [ +]
The Department of Health and Human Services maintains the U.S
Public Health Service Commissioned Corps, the Inactive Reserve
Commission Corps, and the Medical Reserve Corps for deployment
during an emergency. General Schedule (GS) employees are also
eligible to be deployed in an emergency.
34. What is the Commissioned Corps and how does it function?
Answer [ +]
The United States Public Health Service Commissioned Corps is
one of the seven American uniformed services and is tasked with
delivering public health promotion and disease prevention programs.
Commissioned Corps officers hold positions of leadership in
the Department of Health and Human Services as well as other
government offices and agencies. According to its website, the
Commissioned Corps may be deployed to “provide urgently needed
public health and clinical expertise in response to large-scale
local, regional and national public health emergencies and disasters.”
The Office of the Surgeon General oversees the Commissioned
Corps. The Inactive Reserve Corps (IRC) is comprised of public
health professionals who may be called to short or long tours
of active duty with the Commissioned Corps as needed, most often
to provide critical coverage during staffing shortages such
as in times of disaster or emergency.
35. What is the Medical Reserve Corps and how does it function?
Answer [ +]
The Medical Reserve Corps (MRC) is comprised of volunteer civilian
practicing and retired physicians, nurses and other public health
workers formed mainly at the community level. The purpose of
the MRC is to address the community’s ongoing health needs as
well as to assist the community during a large scale emergency.
Willing MRC volunteers can be activated and deployed by the
Secretary to assist with federal response and recovery efforts.
HHS maintains sensitivity to not deploy those needed in their
own communities. If MRC members are activated as intermittent
employees of the public health service, they will be provided
coverage for liability and workers compensation, and will have
license reciprocity as if they were a federal employee. MRC
members activated as intermittent employees are also covered
under the Uniform Services Employment and Re-Employment Rights
Act (USERRA) which protects the reserve components of our uniformed
services so individuals who are deployed do not lose their pre-deployment
jobs.
36. What is the National Disaster Medical System (NDMS) and how
does it function?
Answer [ +]
The National Disaster Medical System (NDMS) is a coordinated
effort of the Department of Homeland Security, the Department
of Defense, the Veteran’s Administration, and the Department
of Health and Human Services in collaboration with states, localities,
and private entities. NDMS Response Teams can be deployed to
provide health services; health related social services, and
other appropriate human services (such as veterinary or mortuary
services) to respond to the needs of victims of a public health
emergency and to be present where and when the Secretary determines
location is at risk of a public health emergency. Activation
and deployment of NDMS teams does not require a formal public
health emergency declaration. NDMS members are intermittent
employees of the public health service. When they are activated
they are federal employees and have FTCA tort liability coverage
and FECA workers' compensation coverage. NDMS also covered under
the Uniform Services Employment and Re-Employment Rights Act
(USERRA) which protects the reserve components of our uniformed
services so individuals who are deployed do not lose their pre-deployment
jobs.
37. How are healthcare providers who provide assistance during an
emergency licensed and registered?
Answer [ +]
The Office of Personnel Management (OPM) regulations and federal job descriptions generally require an employee to be licensed in any state. The federal government determines what qualifications are necessary and is responsible for verification of those qualifications. States have a variety of statutes and regulations to extend license reciprocity. EMAC also contains a licensing reciprocity provision. Profession specific compacts exist in some states such as the Nurse Licensure Compact. In addition, the American Red Cross has negotiated reciprocal licensing agreements with each state.
In 2002, HHS developed the Emergency System for Advanced Registration of Volunteer Health Professionals (ESAR-VHP), a system for advanced registration of healthcare providers to verify licensure, assign standardized credential levels, track hospital privileges, and mobilize volunteers, Registration with ESAR-VHP does not in and of itself constitute federal employment, although those registered in ESAR-VHP could potentially be hired on a temporary basis if HHS were to exercise hiring authority. Registration with ESAR-VHP does not qualify a public health professional for FTCA coverage or FECA coverage and does require an additional mechanism for license reciprocity.
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).
Frequently Asked Questions
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