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Title: Federal Public Health Emergency Law: Implications for State and Local Preparedness and Response A Facilitated Teleconference Sponsored by CDC’s Public Health Law Program and the Coordinating Office of Terrorism Preparedness and Emergency Response


1
Federal Public Health Emergency Law Implications
for State and Local Preparedness and ResponseA
Facilitated Teleconference Sponsored by CDCs
Public Health Law Program and the Coordinating
Office of Terrorism Preparedness and Emergency
Response
April 28, 2009 200-400pm EDT
2
Disclaimer
  • The material contained herein is for
    instructional use only and are not intended as a
    substitute for professional legal or other
    advice. Always seek the advice of an attorney or
    other qualified professional with any questions
    you may have regarding a legal matter.

3
FEMA Disaster Relief
  • Diane Donley
  • Office of Chief Counsel
  • April 28, 2009

4
History
  • 1950 P.L. 81-875 creates Federal disaster
    relief program
  • 1970 Disaster Relief Act (P.L. 91-606)
  • 1974 Disaster Relief Act Amendments (P.L.
    93-288)
  • 1979 E.O. 12127 creates FEMA
  • 1988 Robert T. Stafford Disaster Relief and
    Emergency Assistance Act (P.L. 100-707)
  • 2000 Disaster Mitigation Act of 2000 (P.L.
    106-390)
  • 2002 Homeland Security Act (P.L. 107-296)
  • 2006 Post-Katrina Emergency Management Reform
    Act

5
Primary Disaster Relief Legal Authorities
  • Robert T. Stafford Disaster Relief and Emergency
    Assistance Act, 42 U.S.C. 5121 et seq.
  • Homeland Security Act of 2002 as amended by Post
    Katrina Emergency Reform Act of 2006
  • E.O. 12148, as amended
  • Title 44 of the Code of Federal Regulations

6
The Stafford Act
  • Authorizes the President to provide major
    disaster and emergency declarations to States for
    events that overwhelm State and local capability
  • A declaration triggers statutory authority and
    access by FEMA to the Disaster Relief Fund to
    provide Federal direct and financial assistance
    to render aid, emergency services, and
    rehabilitation assistance
  • Authorizes FEMA to coordinate the administration
    of all disaster relief

7
Primary Mission
  • The primary mission of the Agency 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.
  • Specific activities in support of the mission may
    include partnering with States, local and tribal
    governments, emergency response providers, other
    Federal agencies and the private sector to build
    a national system of emergency management.

8
Major Disaster
  • any natural catastrophe . . . or, regardless
    of cause, any fire, flood, or explosion, in any
    part of the United States, which in the
    determination of the President causes damage of
    sufficient severity and magnitude to warrant
    major disaster assistance under this Act to
    supplement the efforts and available resources of
    States, local governments, and disaster relief
    organizations in alleviating the damage, loss,
    hardship, or suffering caused thereby.

9
Emergency
  • any occasion or instance for which, in the
    determination of the President, Federal
    assistance is needed to supplement State and
    local efforts and capabilities to save lives and
    to protect property and public health and safety,
    or to lessen or avert the threat of a catastrophe
    in any part of the United States.

10
Requests for a Declaration
  • The Governor must execute the States emergency
    plan and state in writing that the situation is
    of such severity and magnitude that effective
    response is beyond the capabilities of the State
    and affected local governments and supplemental
    Federal assistance is necessary.
  • Declaration made by the President specifies the
    types of assistance authorized.

11
Declaration for Primary Federal Responsibility
  • A Governors request is not necessary for the
    President to issue an emergency declaration if
    the emergency involves a Federal primary
    responsibility.
  • Such responsibility rests with the United States
    because the emergency involves a subject area for
    which, under the Constitution or laws of the
    United States, the United States exercises
    exclusive or preeminent responsibility and
    authority.
  • Used for the bombing of the Murrah Federal
    Building in 1995 the Pentagon attack in 2001
    and the Space Shuttle Columbia explosion in 2003.

12
Disaster Assistance
  • Public Assistance
  • Emergency work and permanent work to assist
    States, local governments, and certain private
    non-profits
  • Individual Assistance
  • Direct and financial assistance to individuals
    for housing and other disaster-related needs
  • Hazard Mitigation
  • Assists States and local governments to reduce
    the loss of life and property due to natural
    disasters and enables mitigation measures to be
    implemented during the immediate recovery from a
    disaster

13
Public Assistance
  • Emergency Work 42 U.S.C. 5170b, 42 U.S.C. 5192
  • Assistance essential to meeting immediate threats
    to life and property
  • Debris removal, search and rescue, evacuation,
    emergency medical care, mass care, shelter, food,
    water, temporary facilities for essential
    community services, technical advice
  • Provided directly by the Federal government or by
    grants to state and local governments and
    eligible private non-profits, i.e. Project
    Worksheets
  • Federal share generally 75 though may be raised
    by the President

14
Public Assistance
  • Permanent Work 42 U.S.C. 5172
  • Repair, restoration and replacement of damaged
    facilities owned by states and local governments,
    and eligible private non-profits
  • Provided through grants, i.e. Project
    Worksheets
  • Federal share generally 75 though it may be
    raised by the President

15
Public Assistance
  • Delivery of Emergency Work by Direct Federal
    Assistance
  • Governor certifies that the State cannot perform
    or contract for performance of the requested
    emergency work (e.g. debris removal, search and
    rescue, etc.)
  • FEMA tasks or mission assigns another Federal
    agency to perform the emergency work
  • State remains responsible for applicable
    non-Federal cost share
  • Agency performing the work will be reimbursed by
    FEMA if acting under the Stafford Act rather than
    its own statutory authority
  • PKEMRA amendment allows for accelerated Federal
    assistance in the absence of a specific request
    where necessary to save lives, prevent human
    suffering or mitigate severe damage

16
Mission Assignments, Direct Federal Assistance
PSMAs
  • MAs are authorized under section 402 and 403 of
    Stafford Act and the differences between them.
  • Direct Federal Assistance merely means a MA with
    a cost share.
  • PSMAs There are about 223 now. They are drafts
    and not final documents.

17
Appropriations
  • Disaster Assistance under the Stafford Act is
    funded through appropriations by Congress to the
    Disaster Relief Fund
  • The appropriation is for necessary expenses in
    carrying out the . . . Stafford . . . Act.  
  • Thus, the DRFs use is limited to those purposes
    authorized by the Stafford Act.  Specifically,
    DRF funds may be used as necessary to implement
    Title IV (Major Disaster) and Title V (Emergency)
    of the Stafford Act.

18
Essential Service Providers
  • The head of a Federal agency may not deny or
    impede access to the disaster site to an
    essential service provider whose access is
    necessary to restore and repair an essential
    service. 42 U.S.C. 5189e
  • An essential service provider is a municipal
    entity, nonprofit entity or private for-profit
    entity that provides telecommunications service,
    electrical power, natural gas, water and sewer
    services or any other essential service as
    determined by the President

19
Authority to Assist the Private Sector
  • Facilitate the Federal mission
  • Request by State or local government
  • Work through Infrastructure Liaison or Private
    Sector Office
  • Example -- Security

20
(No Transcript)
21
HHSPublic Health Emergency Authorities
  • Jennifer E. Ray and Susan E. Sherman
  • HHS Office of the General Counsel
  • April 28, 2009

22
Topics
  • Overview of HHS Authorities
  • HHS Authorities for Preparedness and Response
  • Three Areas of Public Health Emergency Response
  • Deployment of Personnel
  • Public Health Emergency Declarations
  • Medical Countermeasure Distribution

23
HHS Authorities -- Statutes
  • Public Health Service Act, 42 U.S.C. 201 et seq.
  • Federal Food, Drug and Cosmetic Act, 21 U.S.C.
    201 et seq.
  • Social Security Act, 42 U.S.C. 301 et seq.
  • Stafford Act, 42 U.S.C. 5121 et seq.
  • National Emergencies Act, 50 U.S.C. 1631

24
Recent Legislation
  • Patriot Act of 2001
  • Public Health Security and Bioterrorism
    Preparedness and Response Act of 2002
  • Homeland Security Act of 2002
  • Smallpox Emergency Personnel Protection Act of
    2003
  • BioShield Act of 2004
  • Public Readiness and Emergency Preparedness
    (PREP) Act of 2005
  • Pandemic and All-Hazards Preparedness Act of 2006

25
HHS Authorities
  • HHS Secretary shall lead all Federal public
    health and medical response to public health
    emergencies and incidents covered by the National
    Response Framework, PHS Act 2801
  • HHS is the lead for Emergency Support Function
    (ESF) 8, Public Health and Medical Services Annex
    and Biological Incident Annex of the National
    Response Framework Support agency for ESF 6,
    Mass Care, Housing, and Human Services
  • The HHS Assistant Secretary for Preparedness and
    Response (ASPR) serves as the Secretarys
    principal advisor on matters related to Federal
    public health and medical preparedness and
    response for public health emergencies, PHS Act
    2811

26
Federal-State Cooperation
  • The Secretary is authorized to develop and
    implement a plan under which HHS personnel,
    equipment, medical supplies, and other resources
    may be effectively used to control epidemics of
    any disease or condition and to meet other health
    emergencies or problems, PHS Act 311
  • The Secretary may, at the request of the State or
    local authority, extend temporary (not in excess
    of six months) assistance to States or localities
    in meeting health emergencies of such a nature as
    to warrant Federal assistance, PHS Act 311
  • The ASPR coordinates with State, local, and
    tribal public health officials, the Emergency
    Management Assistance Compact, health care
    systems, and emergency medical service systems to
    ensure effective integration of Federal public
    health and medical assets during a public health
    emergency, PHS Act 2811(b)(4)(B)

27
Deployment of Personnel
  • Provide medical surge
  • Sheltering/Patient Collection Sites
  • Federal Medical Stations
  • Deployable health care platform that can deliver
    large-scale primary healthcare services in the
    form of non-acute hospital bed surge capacity,
    special needs sheltering capacity, or quarantine
    support
  • Backfill healthcare facilities/mobile medical
    units
  • Assist with patient evacuation
  • Staffing Incident Response Coordination Teams and
    serving as liaisons to other response teams
  • Human services teams (ESF 6)
  • Case management

28
Federal Employees Liability and Licensing
  • Federal Tort Claims Act (FTCA) covered employee
    not personally liable for negligent acts
    committed within scope of Federal employment
  • FTCA for malpractice and negligence claims
    against PHS employees, PHS Act 224
  • Federal Employee Compensation Act (FECA)
    workers comp coverage for Federal civilian
    employees who are injured or killed while in the
    performance of their duties
  • For positions requiring a state license, OPM
    regulations and Federal job descriptions
    generally require an employee to be licensed in
    a state
  • Federal government determines what qualifications
    are necessary and is responsible for verification

29
Volunteer Health Professionals (VHP) Liability
and Licensing
  • Patchwork of liability protections for VHPs (and
    in certain cases, paid healthcare professionals)
  • Mutual aid compacts EMAC
  • State emergency powers to make, amend, or rescind
    temporarily orders, rules, and regulations
    necessary to carry out the states emergency
    functions
  • Statutory provisions extending immunity or
    indemnifying VHPs when Governor declares
    emergency
  • Good Samaritan statutes
  • State Volunteer Protection Acts (VPAs)
  • Uniform Emergency Volunteer Health Practitioners
    Act
  • Federal Volunteer Protection Act of 1997
  • States have a variety of statutory and regulatory
    mechanisms to extend license reciprocity
  • EMAC, State emergency powers, State emergency
    management statutes
  • Profession specific compacts Nurse Licensure
    Compact
  • Red Cross has negotiated reciprocal licensing
    agreements with each state

30
Commissioned Corps
  • Regular Commissioned Corps and Reserve
    Commissioned Corps for duty in time of emergency,
    PHS Act 203
  • Commissioned Corps officers must be citizens, are
    appointed and compensated under separate
    personnel system without regard to civil service
    laws
  • Reserve Corps officers are at all times subject
    to call to active duty by the Surgeon General
  • President may use the Commissioned Corps in war
    or an emergency proclaimed by the President

31
National Disaster Medical System
  • Coordinated effort of DHS, DoD, VA, and HHS
    collaborating with States and public and private
    entities, PHS Act 2812
  • Provide health services, health-related social
    services, other appropriate human services and
    auxiliary services (veterinary, mortuary, and
    other) to respond to the needs of victims of
    public health emergency and be present where and
    when the Secretary determines location is at risk
    of a public health emergency
  • Intermittent employees of Public Health Service
  • FTCA, FECA, and USERRA coverage
  • Healthcare providers only need to be licensed in
    a state

32
Medical Reserve Corps (MRC)
  • Comprised of practicing and retired physicians,
    nurses, and others formed at local (or state)
    level to address their communities ongoing
    public health needs and to assist their
    communities during large-scale emergency
    situations, PHS Act 2813
  • During a public health emergency, the Secretary
    is authorized to activate and deploy willing
    members of the Corps to areas of need, with the
    concurrence of state, local, or tribal officials.
    May also be activated as intermittent employees
    of Public Health Service
  • FTCA, FECA, and USERRA coverage
  • Healthcare providers only need to be licensed in
    a state
  • Secretary may deploy select members without
    hiring and pay travel or transportation expenses,
    including a per diem
  • Such individuals are subject to the laws of the
    State in which their activities are undertaken

33
Emergency System for Advance Registration of
Volunteer Health Professionals (ESAR-VHP)
  • National system of state-based programs that
    include recruitment, advance registration,
    licensure and credential verification, assignment
    of standardized credential levels, and
    mobilization of volunteers, PHS Act 319I
  • Inclusion in network does not constitute Federal
    appointment
  • VHPs who register are generally not Federal
    employees, although HHS could utilize certain
    emergency and temporary hiring authorities to
    hire certain VHPs on a temporary basis
  • In general, VHPS will not qualify for FTCA or
    FECA coverage
  • VHPs will need to obtain a license to practice
    across state lines unless there is a mechanism
    providing them with reciprocity

34
Public Health Emergency (PHE) Declaration
  • The Secretary may declare a PHE if he or she
    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, PHS Act 319
  • Termination
  • Secretarial determination that emergency no
    longer exists or after 90 days, whichever occurs
    first
  • Renewal
  • May be renewed by the Secretary for additional 90
    days periods

35
Following a Declaration the Secretary May
  • Access Public Health Emergency Fund (when funds
    are available)
  • Consistent with other authorities, make grants,
    provide awards for expenses, and enter into
    contracts and conduct and support investigations
  • Extend deadlines, waive sanctions for submission
    of data or reports

36
Support Other Discretionary Actions by the
Secretary
  • Waive certain Medicare, Medicaid and CHIP
    requirements (including temporary waiver of
    EMTALA), SSA 1135
  • Waive certain HIPAA sanctions for 72 hours, SSA
    1135
  • Declare an emergency justifying emergency use of
    an investigational product, FFDCA 564
  • Waive certain requirements for medical
    countermeasure distribution, FFDCA 505-1
  • Exempt select agent requirements, PHS Act 351A
  • Appoint temporary personnel, waive dual
    compensation reduction, 5 C.F.R. 213.3102(i)(1),
    5 U.S.C. 8344, 8468
  • Adjust Medicare payment for Part B drugs, SSA
    1847A
  • Waive of Ryan White HIV/AIDS requirements, PHS
    Act XXVI

37
Waiver under Section 1135 of the Social Security
Act (SSA)
  • Waiver authority can be used to waive or modify
    certain Medicare, Medicaid, and CHIP requirements
    applicable to health care providers
  • Enumerated requirements can be waived or modified
  • Conditions of participation, program
    participation requirements, certification
    requirements
  • EMTALA sanctions
  • Stark self referral sanctions
  • Certain HIPAA sanctions
  • Deadlines and timetables for the performance of
    required activities (can be modified only, not
    waived)
  • Requirements that healthcare providers hold
    licenses in the State in which they provide
    services (for the purposes of Medicare, Medicaid,
    and CHIP only)
  • Other

38
1135 Waiver Authority
  • Both a Presidential declaration under the
    Stafford Act or the National Emergencies Act and
    a HHS Secretarial declaration of a public health
    emergency must be made to trigger section 1135
    authority
  • Applies only in the emergency area during the
    emergency period
  • Emergency area is the geographic area covered by
    the two triggering declarations
  • Emergency period is
  • End of Presidential declaration
  • End of public health emergency declaration OR
  • 60 days from the date the waiver is published

39
1135 Waiver Authority
  • Waivers of HIPAA sanctions and non-pandemic
    related waivers of sanctions under EMTALA are
    generally limited to a 72 hour period beginning
    upon implementation of a hospital disaster
    protocol
  • HIPAA and EMTALA waivers are not effective for
    actions that discriminate among individuals on
    the basis of payment source or ability to pay
  • When a public health emergency involves pandemic
    infectious disease, waivers of EMTALA sanctions
    can extend through the duration of the public
    health emergency

40
PHE/1135 Requests
  • Unlike Stafford Act declarations that ordinarily
    require a formal request by a state Governor,
    there is no statutory requirement that a Governor
    or other entity make a formal request for a PHE
    declaration or an 1135 waiver
  • However, Governors may wish to make a formal
    request to HHS for a PHE/1135 waiver
  • When state officials believe that a PHE and 1135
    waivers are needed, they usually work with their
    HHS Regional Emergency Coordinator and regional
    CMS officials to discuss their request
  • When the Secretary of HHS issues an 1135 waiver,
    generally hospitals and other entities need to
    work with HHS Regional CMS officials who will
    facilitate CMS granting of specific waiver
    requests on a case-by-case basis.

41
Strategic National Stockpile
  • Secretary of HHS, in coordination with the
    Secretary of Homeland Security, and consultation
    with Director, CDC, maintains a stockpile of
    drugs, vaccines, and other biological products,
    medical devices, and other supplies in such
    numbers, types, and amounts 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, PHS Act 319F-2
  • ASPR exercises the responsibilities and
    authorities of the Secretary with respect to
    coordination of the Strategic National Stockpile
    (SNS), PHS Act 2811

42
Stockpile Deployment
  • As required by Secretary of Homeland Security to
    respond to an actual or potential emergency
  • At the discretion of 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
  • Domestic and foreign deployments that meet
    statutory criteria

43
Emergency Use of Investigational Drugs (EUA)
  • The Secretary may authorize use of unapproved new
    drugs, unlicensed biological products, or
    unapproved/not cleared medical devices to respond
    to an emergency involving a chemical, biological,
    radiological, or nuclear agent
  • Serious or Life-Threatening Disease or Condition
  • Reasonable to believe product may be effective,
    known and potential benefits outweigh potential
    risks, no adequate, approved, available
    alternative
  • Applies to unapproved products and unapproved
    uses of approved products, FFDCA 564

44
EUA Process
  • Determination by DHS Secretary of an actual or
    significant potential for domestic emergency
    involving heightened risk of attack with a
    specified chemical, biological, radiological, or
    nuclear (CBRN) agent, or
  • Determination by DOD Secretary of an actual or
    significant potential for military emergency
    involving a heightened risk to US military forces
    of attack with a specified CBRN agent or
  • Determination by the HHS Secretary under section
    319 of the PHS Act of a public health emergency
    that actually or potentially affects national
    security and involves a specified CRBN agent

45
EUA Process
  • HHS Secretary declares emergency justifying EUA
  • Specifies CBRN agent and product
  • Different from a PHE under section 319 of the PHS
    Act
  • Different from a PREP Act declaration
  • FDA Commissioner Issues EUA
  • Disease or conditions for which product may be
    used to diagnose, prevent, or treat
  • Secretarys findings regarding known and
    potential risks and benefits, safety, potential
    effectiveness and assessment of available
    scientific evidence
  • Required conditions, additional conditions
  • Federal Register Notice of Declarations, EUAs

46
EUA Duration
  • Secretarys Declaration terminates in one year or
    when circumstances justifying the EUA cease to
    exist
  • May be renewed
  • FDA Authorization lasts until Secretarys
    declaration terminates or authorization is
    revoked if criteria for authorization no longer
    are met
  • May be renewed

47
Public Readiness and Emergency Preparedness
(PREP) Act
  • Authorizes Secretary to issue a declaration to
    provide immunity from tort liability (except for
    willful misconduct) for claims
  • Death physical, mental, emotional injury,
    illness, disability, condition, fear thereof
    medical monitoring, property damage, loss,
    business interruption
  • Causally related to development, distribution,
    administration or use of covered
    countermeasures
  • Against covered persons, PHS Act 319F-3
  • Authorizes emergency fund in U.S. Treasury for
    compensation for injuries from covered
    countermeasures, PHS Act 319F-4

48
Covered Countermeasures
  • Qualified Pandemic or Epidemic Product
  • drug, biological product, device against
    pandemic or epidemic disease (or against adverse
    effects of such drugs, biological products, or
    devices)
  • Approved, licensed, or under Emergency Use
    Authorization (EUA), Investigational Drug (IND)
    or Device (IDE) application
  • Security Countermeasure
  • Drug, biological product device against harm from
    biological, chemical, radiological or nuclear
    agent (or against adverse effects of such drugs,
    biological products, or devices)
  • Necessary to protect public health
  • Approved, cleared, licensed, qualify for approval
    or licensing within eight years of federal
    procurement, EUA, IND, or IDE
  • Product Authorized under EUA

49
Covered Persons
  • Manufacturers
  • Distributors
  • Program Planners (State, local government, tribe,
    others who supervise or administer countermeasure
    programs)
  • Qualified Persons (licensed health professionals
    and others identified by the Secretary who
    prescribe, administer, or dispense
    countermeasures)
  • United States
  • Officials, Agents, Employees of all of the above

50
Secretarys Declaration
  • Considers desirability of encouraging design,
    development, clinical testing, investigation,
    manufacture, labeling, distribution, formulation,
    packaging, marketing, promotion, sale, purchase,
    donation, dispensing, prescribing, administering,
    licensing, use of countermeasure, and other
    relevant factors
  • Determines that disease, health condition, or
    threat to health constitutes a public health
    emergency or a credible risk of future health
    emergency
  • Recommends manufacture, testing, development,
    distribution, administration or use of
    countermeasures
  • States liability immunity in effect for
    recommended activities

51
Declaration Contents
  • Category of diseases, health conditions, or
    health threats for which administration and use
    of countermeasure is recommended
  • Effective time period
  • Population receiving countermeasure
  • Geographic area of administration and use
  • Any limitations on distribution
  • Any additional qualified persons

52
Limitations
  • Willful misconduct
  • Countermeasures used and administered outside
    conditions of declarations
  • Claims not causally related
  • Claims filed in foreign jurisdictions
  • Claims other than tort liability
  • Countermeasures obtained through non-voluntary
    means (government program planners only current
    declarations only)

53
Current Declarations
  • Pandemic Influenza Vaccines, 72 Fed. Reg. 4710,
    67731 73 Fed. Reg. 61871
  • Pandemic Influenza Antivirals, 73 Fed. Reg. 61861
  • 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

54
Quarantine and Isolation Law The
BasicsKim Dammers, JDAssistant US Attorney
(on detail to CDC)
  • Adapted from PHEL V.30
  • Developed by the
  • Public Health Law Program
  • U.S. Centers for Disease Control and Prevention

54
55
Social Distancing Measures Used to Quench
Epidemics
  • Non-pharmaceutical interventions
  • Snow day restrictions (e.g., shelter-in-place)
  • Close schools, daycare centers
  • Cancel large public gatherings (e.g., concerts,
    theaters)
  • Limit other public contacts (e.g., markets,
    public transit)
  • Encourage selected / non-essential workers to
    stay home
  • Implement telecommuting to minimize economic
    impact

55
56
Isolation and Quarantine
  • Isolation refers to the separation of persons
    who have a specific infectious illness from those
    who are healthy and the restriction of their
    movement to stop the spread of that illness. . .
  • Quarantine refers to the separation and
    restriction of movement of persons who, while not
    yet ill, have been exposed to an infectious agent
    and therefore may become infectious.

56
57
Quarantine ObjectiveReduce Transmission of
Disease
  • Effectiveness depends on
  • Time period between exposure and onset of
    communicability
  • Mode of transmission
  • Actual distance of separation required
  • Treatment options
  • Options for isolating patients when in
    communicable state

57
58
Federal Quarantine/Isolation
  • Qualifying Disease listed in Exec. Order
  • cholera, diphtheria, infectious TB, plague,
    smallpox, yellow fever, viral hemorrhagic fevers
    (Ebloa), SARS, and pandemic influenza
  • Two separate reg parts Part 70 domestic
    interstate quarantine and Part 71 travelers
    seeking entry
  • Court Order not necessary

59
Quarantine and IsolationConstitutional
Requirements
  • Quarantine and isolation restrict individual
    liberty
  • Similar to criminal arrest or civil commitment
  • U.S. Constitution, 5th and 14th Amendments
  • 5th Due Process Clause nor be deprived of life,
    liberty, or property, without due process of law
  • 14th Amendment makes due process applicable to
    states
  • Basic Due Process for quarantine and isolation
  • Right to notice
  • Right to counsel at certain stages
  • Right to hearing on request
  • Reasonable belief for detention

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Federal Quarantine/IsolationDomestic
  • Current Regulations
  • Somewhat Vague
  • CDC acts when Interstate or local control
    inadequate
  • Impose travel permits
  • Require interstate travelers to report to local
    PH Dept.
  • Order quarantine, isolation to prevent disease
    spread
  • No express due process provisions

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Federal Quarantine/IsolationDomestic
  • Proposed Regulations
  • Adds definitions, same disease list, same
    Interstate
  • Disease must be at qualifying stage
  • Precommunicable but likely to cause PH emergency
    or communicable
  • Provisional quarantine up to 3 days
  • Hearing after 3 days with hearing officer, no
    right to lawyer
  • Quarantine - duration based on incubation
    communicability periods
  • Habeas petition, counsel attaches, admin
    exhaustion
  • Forced medical exams, treatment

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Quarantine and Isolation Hearings Typical
Procedural Requirements
  • Quarantine / isolation administrative order
  • Supporting affidavits and factual findings
  • Notice and explanation of due process procedures
  • Service of process (likely by law enforcement
    officers, not private process servers)
  • Opportunity to challenge factual basis
  • Arrange for appearances at hearing
  • Possible telephonic / electronic hearings
  • Right to representation

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Legal Readiness Hearings
  • Recognized need systems for large number of
    hearing requests in event of mass quarantine
  • Service of process
  • Court-appointed counsel if habeas
  • In-person vs. electronic / telephonic hearings
  • United States v. Crawford
  • Protecting hearing officers, courts and
    participants
  • Documentation and affidavits
  • Ancillary legal challenges
  • Business disruption, TROs, injunctions

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Hearings and Modern Isolation Procedures Can Be
Rigorous
  • Confinement for Treatment
  • Best v. Bellevue Hospital, New York (2004)
  • Non-infectious TB patient confined when sought to
    leave hospital and refused to cooperate with
    treatment
  • Filed suit against health department and
    hospitals
  • Was Mr. Best dangerous to himself and community?
  • Did Mr. Best have adequate right to hearing?
  • Health department prevailed
  • But only after 4 hearings and 7 administrative
    and state and federal judicial orders over 2
    years

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Quarantine and Isolation Hearings Appeal
Variations Habeas Corpus
  • In some states, health departments issue
    administrative quarantine orders and state courts
    handle any appeals
  • Some states have an administrative appeal
    mechanism that must first be exhausted before an
    individual can seek judicial review
  • Individuals have a constitutional right to
    challenge their detention through a habeas corpus
    petition before a federal court after other
    appeals have been exhausted

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Quarantine and IsolationObligations to Those
Confined
  • Basic needs
  • Food, medical care, safety and sanitary needs
  • Separation of isolated from quarantined persons
  • Medical treatment during confinement
  • Habitable accommodation
  • Protection from known threats
  • Religious and dietary considerations

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Constitutional Requirement for Least Restrictive
Means
  • Courts tend to favor the principle of detention
    by least restrictive means necessary when
    applied to individual freedom in quarantine
    situations
  • Analogous to principles underlying Directly
    Observed Therapy (DOT) for TB cases
  • Includes possible confinement in individuals
    residence or other public or private premises
  • Some states may require least restrictive means
  • Public health must also protect the community in
    an emergency

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State and Local Jurisdictional Issues Regarding
Protection of People
  • Remember Police powers, including public health
    authority, are reserved to states under the U.S.
    Constitutions 10th Amendment
  • But federal and international jurisdictional
    issues may arise in a given case

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Federal Jurisdictional Issues
  • Current federal statute (PHS Act Sec. 361) was
    enacted in an era when immigrants arrived by sea
  • Designed to control international importation and
    interstate spread of certain diseases
  • Not designed to prevent infectious persons bound
    for other countries from leaving U.S.
  • Requires that specific quarantinable diseases be
    listed in a Presidential Executive Order

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Federal Powers Quarantine and Isolation
  • The Secretary of HHS (through CDC) can
  • detain, medically examine, or conditionally
    release persons suspected of carrying certain
    communicable diseases
  • Authority applies only if communicable disease
    has been designated in a Presidential Executive
    Order
  • SARS added 2003
  • Avian influenza added 2005

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Scope of Federal Quarantine Power
  • Interstate / International - persons entering
  • Into the U.S. or possessions from foreign
    countries
  • From one state or possession into any other state
    or possession, BUT ALSO
  • Within a state, if individual is reasonably
    believed to be infected
  • If state / local disease control measures are
    inadequate to control spread of disease
  • close coordination between state and CDC is
    critical

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Federal QuarantineEnforcement Flexibility
  • Sec. 311 of PHS Act HHS authorized to accept
    state and local assistance in enforcing federal
    quarantine order
  • Also, HHS can assist states and political
    subdivisions in enforcing their quarantines
  • U.S. military may assist enforcement of state
    quarantine at seaports
  • Note this is an exception to the normal
    prohibition on the use of military for domestic
    law enforcement

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SARS Lessons from Canada
  • Communications in Toronto demystified
    quarantine
  • Hotlines staffed by 80 nurses received 300,000
    calls
  • Community meetings were held
  • Information posted on websites in 14 languages
  • Substantial social cohesion prevailed
  • Over 30,000 voluntary quarantines took place
  • Only 27 formal quarantine orders needed
  • The sole appeal was withdrawn

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Lessons from Canada Compliance
  • Despite substantial voluntary compliance in
    Toronto during the 2003 SARS outbreak, important
    detracting factors were identified
  • Lost wages or income of those quarantined
  • Groceries and essential services
  • Boredom of persons sheltering at home
  • Good communication was an essential factor in
    encouraging voluntary compliance with the public
    health orders

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International Health Regulations (IHR)
  • Following 2003 SARS, the World Health
    Organization (WHO) revised the International
    Health Regulations
  • IHR contain operational definition of a public
    health emergency of international concern that
    triggers increased control responsibilities for
    nations

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International Health Regulations (IHR)
  • The WHO has no free-standing international
    quarantine authority
  • Quarantine is still a country-by-country power
  • The revised IHR preserve the important WHO roles
    of collecting international outbreak information
    from various sources and of issuing traveler
    advisories when appropriate

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Questions?
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Conclusion
  • For more information on public health emergency
    law, please visit CDCs Public Health Law Program
    Website at
  • www.cdc.gov/phlp.
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