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Federal Public Health Federal Public Health Emergency Law: Emergency Law:

Implications for State and Implications for State and Local Preparedness and Local Preparedness and

ResponseResponse

A Facilitated Teleconference Sponsored by A Facilitated Teleconference Sponsored by CDC’s Public Health Law Program and the CDC’s Public Health Law Program and the

Coordinating Office of Terrorism Preparedness Coordinating Office of Terrorism Preparedness and Emergency Response and Emergency Response April 28, 2009April 28, 2009

2:00-4:00pm EDT2:00-4:00pm EDT

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.

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FEMA Disaster FEMA Disaster ReliefRelief

Diane DonleyDiane DonleyOffice of Chief CounselOffice of Chief Counsel

202-646-3120202-646-3120Diane.Donley@DHS.GovDiane.Donley@DHS.Gov

April 28, 2009April 28, 2009

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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

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Primary Disaster Relief Primary Disaster Relief Legal AuthoritiesLegal Authorities

Robert T. Stafford Disaster Relief and Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 Emergency Assistance Act, 42 U.S.C. 5121 et seq.et seq.

Homeland Security Act of 2002 as Homeland Security Act of 2002 as amended by Post Katrina Emergency amended by Post Katrina Emergency Reform Act of 2006Reform Act of 2006

E.O. 12148, as amendedE.O. 12148, as amendedTitle 44 of the Code of Federal Title 44 of the Code of Federal RegulationsRegulations

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The Stafford ActThe Stafford ActAuthorizes the President to provide major disaster Authorizes the President to provide major disaster and emergency declarations to States for events and emergency declarations to States for events that overwhelm State and local capabilitythat overwhelm State and local capability

A declaration triggers statutory authority and A declaration triggers statutory authority and access by FEMA to the Disaster Relief Fund to access by FEMA to the Disaster Relief Fund to provide Federal direct and financial assistance to provide Federal direct and financial assistance to render aid, emergency services, and rehabilitation render aid, emergency services, and rehabilitation assistanceassistance

Authorizes FEMA to coordinate the administration Authorizes FEMA to coordinate the administration of all disaster relief of all disaster relief

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Primary MissionPrimary Mission ““The primary mission of the Agency is to reduce the The primary mission of the Agency is to reduce the

loss of life and property and protect the Nation from all loss of life and property and protect the Nation from all hazards, including natural disasters, acts of terrorism, hazards, including natural disasters, acts of terrorism, and other man-made disasters, by leading and and other man-made disasters, by leading and supporting the Nation in a risk-based, comprehensive supporting the Nation in a risk-based, comprehensive emergency management system of preparedness, emergency management system of preparedness, protection, response, recovery, and mitigation.”protection, response, recovery, and mitigation.”

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

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Major DisasterMajor Disaster

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

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EmergencyEmergency

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

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Requests for a Requests for a DeclarationDeclaration

The Governor must execute the State’s The Governor must execute the State’s emergency plan and state in writing that the emergency plan and state in writing that the situation is of such severity and magnitude situation is of such severity and magnitude that effective response is beyond the that effective response is beyond the capabilities of the State and affected local capabilities of the State and affected local governments and supplemental Federal governments and supplemental Federal assistance is necessary.assistance is necessary.

Declaration made by the President specifies Declaration made by the President specifies the types of assistance authorized.the types of assistance authorized.

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Declaration for Primary Declaration for Primary Federal ResponsibilityFederal Responsibility

A Governor’s request is not necessary for the A Governor’s request is not necessary for the President to issue an emergency declaration if the President to issue an emergency declaration if the emergency involves a “Federal primary emergency involves a “Federal primary responsibility.”responsibility.”

Such responsibility rests with the United States Such responsibility rests with the United States because the emergency involves a subject area for because the emergency involves a subject area for which, under the Constitution or laws of the United which, under the Constitution or laws of the United States, the United States exercises exclusive or States, the United States exercises exclusive or preeminent responsibility and authority.preeminent responsibility and authority.

Used for the bombing of the Murrah Federal Used for the bombing of the Murrah Federal Building in 1995; the Pentagon attack in 2001; and Building in 1995; the Pentagon attack in 2001; and the Space Shuttle Columbia explosion in 2003.the Space Shuttle Columbia explosion in 2003.

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Disaster AssistanceDisaster Assistance Public AssistancePublic Assistance

Emergency work and permanent work to assist Emergency work and permanent work to assist States, local governments, and certain private non-States, local governments, and certain private non-profitsprofits

Individual AssistanceIndividual Assistance Direct and financial assistance to individuals for Direct and financial assistance to individuals for

housing and other disaster-related needshousing and other disaster-related needs

Hazard MitigationHazard Mitigation Assists States and local governments to reduce the Assists States and local governments to reduce the

loss of life and property due to natural disasters and loss of life and property due to natural disasters and enables mitigation measures to be implemented enables mitigation measures to be implemented during the immediate recovery from a disasterduring the immediate recovery from a disaster

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Public AssistancePublic Assistance Emergency Work: 42 U.S.C. 5170b, 42 Emergency Work: 42 U.S.C. 5170b, 42

U.S.C. 5192U.S.C. 5192 Assistance essential to meeting immediate threats to Assistance essential to meeting immediate threats to

life and propertylife and property Debris removal, search and rescue, evacuation, Debris removal, search and rescue, evacuation,

emergency medical care, mass care, shelter, food, emergency medical care, mass care, shelter, food, water, temporary facilities for essential community water, temporary facilities for essential community services, technical adviceservices, technical advice

Provided directly by the Federal government or by Provided directly by the Federal government or by grants to state and local governments and eligible grants to state and local governments and eligible private non-profits, i.e. “Project Worksheets”private non-profits, i.e. “Project Worksheets”

Federal share generally 75% though may be raised by Federal share generally 75% though may be raised by the Presidentthe President

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Public AssistancePublic Assistance

Permanent Work: 42 U.S.C. 5172Permanent Work: 42 U.S.C. 5172 Repair, restoration and replacement of Repair, restoration and replacement of

damaged facilities owned by states and damaged facilities owned by states and local governments, and eligible private local governments, and eligible private non-profitsnon-profits

Provided through grants, i.e. “Project Provided through grants, i.e. “Project Worksheets”Worksheets”

Federal share generally 75% though it Federal share generally 75% though it may be raised by the Presidentmay be raised by the President

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Public AssistancePublic Assistance Delivery of Emergency Work by Direct Federal Delivery of Emergency Work by Direct Federal

AssistanceAssistance Governor certifies that the State cannot perform or contract for Governor certifies that the State cannot perform or contract for

performance of the requested emergency work (e.g. debris performance of the requested emergency work (e.g. debris removal, search and rescue, etc.)removal, search and rescue, etc.)

FEMA tasks or “mission assigns” another Federal agency to FEMA tasks or “mission assigns” another Federal agency to perform the emergency workperform the emergency work

State remains responsible for applicable non-Federal cost shareState remains responsible for applicable non-Federal cost share Agency performing the work will be reimbursed by FEMA if Agency performing the work will be reimbursed by FEMA if

acting under the Stafford Act rather than its own statutory acting under the Stafford Act rather than its own statutory authority authority

PKEMRA amendment allows for “accelerated Federal PKEMRA amendment allows for “accelerated Federal assistance” in the absence of a specific request where necessary assistance” in the absence of a specific request where necessary to save lives, prevent human suffering or mitigate severe to save lives, prevent human suffering or mitigate severe damagedamage

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Mission Assignments, Mission Assignments, Direct Federal Assistance & Direct Federal Assistance &

PSMAsPSMAs MAs are authorized under section MAs are authorized under section

402 and 403 of Stafford Act and the 402 and 403 of Stafford Act and the differences between them.differences between them.

Direct Federal Assistance merely Direct Federal Assistance merely means a MA with a cost share.means a MA with a cost share.

PSMAs – There are about 223 now. PSMAs – There are about 223 now. They are drafts and not final They are drafts and not final documents. documents.

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AppropriationsAppropriations Disaster Assistance under the Stafford Act is Disaster Assistance under the Stafford Act is

funded through appropriations by Congress to funded through appropriations by Congress to the “Disaster Relief Fund”the “Disaster Relief Fund”

The appropriation is “[f]or necessary expenses The appropriation is “[f]or necessary expenses in carrying out the . . . Stafford . . . Act.”  in carrying out the . . . Stafford . . . Act.”  

Thus, the DRF’s use is limited to those Thus, the DRF’s use is limited to those purposes authorized by the Stafford Act.  purposes authorized by the Stafford Act.  Specifically, DRF funds may be used as Specifically, DRF funds may be used as necessary to implement Title IV (Major necessary to implement Title IV (Major Disaster) and Title V (Emergency) of the Disaster) and Title V (Emergency) of the Stafford Act. Stafford Act.

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Essential Service Essential Service ProvidersProviders The head of a Federal agency may not deny The head of a Federal agency may not deny

or impede access to the disaster site to an or impede access to the disaster site to an essential service provider whose access is essential service provider whose access is necessary to restore and repair an essential necessary to restore and repair an essential service. 42 U.S.C. 5189eservice. 42 U.S.C. 5189e

An essential service provider is a municipal An essential service provider is a municipal entity, nonprofit entity or private for-profit entity, nonprofit entity or private for-profit entity that provides telecommunications entity that provides telecommunications service, electrical power, natural gas, water service, electrical power, natural gas, water and sewer services or any other essential and sewer services or any other essential service as determined by the Presidentservice as determined by the President

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Authority to Assist the Authority to Assist the Private SectorPrivate Sector

Facilitate the Federal missionFacilitate the Federal mission Request by State or local Request by State or local

governmentgovernment Work through Infrastructure Work through Infrastructure

Liaison or Private Sector OfficeLiaison or Private Sector Office Example -- SecurityExample -- Security

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HHSHHSPublic Health Public Health

Emergency AuthoritiesEmergency Authorities

Jennifer E. Ray and Susan E. Jennifer E. Ray and Susan E. ShermanSherman

HHS Office of the General HHS Office of the General CounselCounsel

April 28, 2009April 28, 2009

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TopicsTopics

Overview of HHS AuthoritiesOverview of HHS Authorities HHS Authorities for Preparedness HHS Authorities for Preparedness

and Responseand Response Three Areas of Public Health Three Areas of Public Health

Emergency Response:Emergency Response: Deployment of PersonnelDeployment of Personnel Public Health Emergency DeclarationsPublic Health Emergency Declarations Medical Countermeasure DistributionMedical Countermeasure Distribution

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HHS Authorities -- HHS Authorities -- StatutesStatutes

Public Health Service Act, 42 U.S.C. Public Health Service Act, 42 U.S.C. 201 et seq.201 et seq.

Federal Food, Drug and Cosmetic Act, Federal Food, Drug and Cosmetic Act, 21 U.S.C. 201 et seq.21 U.S.C. 201 et seq.

Social Security Act, 42 U.S.C. 301 et Social Security Act, 42 U.S.C. 301 et seq.seq.

Stafford Act, 42 U.S.C. 5121 et seq.Stafford Act, 42 U.S.C. 5121 et seq. National Emergencies Act, 50 U.S.C. National Emergencies Act, 50 U.S.C.

16311631

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Recent LegislationRecent Legislation Patriot Act of 2001Patriot Act of 2001 Public Health Security and Bioterrorism Public Health Security and Bioterrorism

Preparedness and Response Act of 2002 Preparedness and Response Act of 2002 Homeland Security Act of 2002Homeland Security Act of 2002 Smallpox Emergency Personnel Protection Act of Smallpox Emergency Personnel Protection Act of

2003 2003 BioShield Act of 2004BioShield Act of 2004 Public Readiness and Emergency Preparedness Public Readiness and Emergency Preparedness

(PREP) Act of 2005(PREP) Act of 2005 Pandemic and All-Hazards Preparedness Act of Pandemic and All-Hazards Preparedness Act of

20062006

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HHS Authorities HHS Authorities HHS Secretary “shall lead all Federal public health HHS Secretary “shall lead all Federal public health

and medical response to public health emergencies and medical response to public health emergencies and incidents covered by the National Response and incidents covered by the National Response [Framework]”, PHS Act 2801[Framework]”, PHS Act 2801

HHS is the lead for Emergency Support Function HHS is the lead for Emergency Support Function (ESF) 8, Public Health and Medical Services Annex (ESF) 8, Public Health and Medical Services Annex and Biological Incident Annex of the National and Biological Incident Annex of the National Response Framework; Support agency for ESF 6, Response Framework; Support agency for ESF 6, Mass Care, Housing, and Human ServicesMass Care, Housing, and Human Services

The HHS Assistant Secretary for Preparedness and The HHS Assistant Secretary for Preparedness and Response (ASPR) serves as the Secretary’s principal Response (ASPR) serves as the Secretary’s principal advisor on matters related to Federal public health advisor on matters related to Federal public health and medical preparedness and response for public and medical preparedness and response for public health emergencies, PHS Act 2811health emergencies, PHS Act 2811

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Federal-State Federal-State CooperationCooperation

The Secretary is authorized to develop and implement a The Secretary is authorized to develop and implement a plan under which HHS personnel, equipment, medical plan under which HHS personnel, equipment, medical supplies, and other resources may be effectively used to supplies, and other resources may be effectively used to control epidemics of any disease or condition and to meet control epidemics of any disease or condition and to meet other health emergencies or problems, PHS Act 311other health emergencies or problems, PHS Act 311

The Secretary may, at the request of the State or local The Secretary may, at the request of the State or local authority, extend temporary (not in excess of six months) authority, extend temporary (not in excess of six months) assistance to States or localities in meeting health assistance to States or localities in meeting health emergencies of such a nature as to warrant Federal emergencies of such a nature as to warrant Federal assistance, PHS Act 311assistance, PHS Act 311

The ASPR coordinates with State, local, and tribal public The ASPR coordinates with State, local, and tribal public health officials, the Emergency Management Assistance health officials, the Emergency Management Assistance Compact, health care systems, and emergency medical Compact, health care systems, and emergency medical service systems to ensure effective integration of Federal service systems to ensure effective integration of Federal public health and medical assets during a public health public health and medical assets during a public health emergency, PHS Act 2811(b)(4)(B)emergency, PHS Act 2811(b)(4)(B)

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Deployment of PersonnelDeployment of Personnel Provide medical surgeProvide medical surge

Sheltering/Patient Collection SitesSheltering/Patient Collection Sites Federal Medical StationsFederal Medical Stations

Deployable health care platform that can deliver large-Deployable health care platform that can deliver large-scale primary healthcare services in the form of non-scale primary healthcare services in the form of non-acute hospital bed surge capacity, special needs acute hospital bed surge capacity, special needs sheltering capacity, or quarantine supportsheltering capacity, or quarantine support

Backfill healthcare facilities/mobile medical unitsBackfill healthcare facilities/mobile medical units Assist with patient evacuationAssist with patient evacuation Staffing Incident Response Coordination Staffing Incident Response Coordination

Teams and serving as liaisons to other Teams and serving as liaisons to other response teamsresponse teams

Human services teams (ESF #6)Human services teams (ESF #6) Case management Case management

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Federal Employees – Federal Employees – Liability and Licensing Liability and Licensing

Federal Tort Claims Act (FTCA) – covered employee Federal Tort Claims Act (FTCA) – covered employee not personally liable for negligent acts committed not personally liable for negligent acts committed within scope of Federal employmentwithin scope of Federal employment FTCA for malpractice and negligence claims against PHS FTCA for malpractice and negligence claims against PHS

employees, PHS Act 224 employees, PHS Act 224 Federal Employee Compensation Act (FECA) – Federal Employee Compensation Act (FECA) –

worker’s comp coverage for Federal civilian worker’s comp coverage for Federal civilian employees who are injured or killed while in the employees who are injured or killed while in the performance of their dutiesperformance of their duties

For positions requiring a state license, OPM For positions requiring a state license, OPM regulations and Federal job descriptions generally regulations and Federal job descriptions generally require an employee to be licensed in “a” staterequire an employee to be licensed in “a” state

Federal government determines what qualifications Federal government determines what qualifications are necessary and is responsible for verificationare necessary and is responsible for verification

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Volunteer Health Volunteer Health Professionals (VHP) – Professionals (VHP) –

Liability and LicensingLiability and Licensing Patchwork of liability protections for VHPs (and in certain Patchwork of liability protections for VHPs (and in certain

cases, paid healthcare professionals)cases, paid healthcare professionals) Mutual aid compacts – EMAC Mutual aid compacts – EMAC State emergency powers to make, amend, or rescind temporarily State emergency powers to make, amend, or rescind temporarily

orders, rules, and regulations necessary to carry out the state’s orders, rules, and regulations necessary to carry out the state’s emergency functionsemergency functions

Statutory provisions extending immunity or indemnifying VHPs Statutory provisions extending immunity or indemnifying VHPs when Governor declares emergencywhen Governor declares emergency

Good Samaritan statutesGood Samaritan statutes State Volunteer Protection Acts (VPAs) State Volunteer Protection Acts (VPAs) Uniform Emergency Volunteer Health Practitioners ActUniform Emergency Volunteer Health Practitioners Act Federal Volunteer Protection Act of 1997Federal Volunteer Protection Act of 1997

States have a variety of statutory and regulatory mechanisms to States have a variety of statutory and regulatory mechanisms to extend license reciprocityextend license reciprocity EMAC, State emergency powers, State emergency management EMAC, State emergency powers, State emergency management

statutesstatutes Profession specific compacts – Nurse Licensure CompactProfession specific compacts – Nurse Licensure Compact Red Cross has negotiated reciprocal licensing agreements with Red Cross has negotiated reciprocal licensing agreements with

each stateeach state

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Commissioned CorpsCommissioned Corps

Regular Commissioned Corps and Reserve Regular Commissioned Corps and Reserve Commissioned Corps for duty in time of Commissioned Corps for duty in time of emergency, PHS Act 203emergency, PHS Act 203 Commissioned Corps officers must be citizens, are Commissioned Corps officers must be citizens, are

appointed and compensated under separate appointed and compensated under separate personnel system without regard to civil service personnel system without regard to civil service lawslaws

Reserve Corps officers are at all times subject to Reserve Corps officers are at all times subject to call to active duty by the Surgeon Generalcall to active duty by the Surgeon General

President may use the Commissioned Corps President may use the Commissioned Corps in war or an emergency proclaimed by the in war or an emergency proclaimed by the President President

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National Disaster Medical National Disaster Medical SystemSystem

Coordinated effort of DHS, DoD, VA, and HHS Coordinated effort of DHS, DoD, VA, and HHS collaborating with States and public and private collaborating with States and public and private entities, PHS Act 2812entities, PHS Act 2812

Provide health services, health-related social Provide health services, health-related social services, other appropriate human services and services, other appropriate human services and auxiliary services (veterinary, mortuary, and auxiliary services (veterinary, mortuary, and other) to respond to the needs of victims of other) to respond to the needs of victims of public health emergency and be present where public health emergency and be present where and when the Secretary determines location is and when the Secretary determines location is at risk of a public health emergencyat risk of a public health emergency

Intermittent employees of Public Health ServiceIntermittent employees of Public Health Service FTCA, FECA, and USERRA coverage FTCA, FECA, and USERRA coverage Healthcare providers only need to be licensed in “a” Healthcare providers only need to be licensed in “a”

statestate

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Medical Reserve Corps Medical Reserve Corps (MRC)(MRC)

Comprised of practicing and retired physicians, nurses, Comprised of practicing and retired physicians, nurses, and others formed at local (or state) level to address and others formed at local (or state) level to address their communities’ ongoing public health needs and to their communities’ ongoing public health needs and to assist their communities during large-scale emergency assist their communities during large-scale emergency situations, PHS Act 2813situations, PHS Act 2813

During a public health emergency, the Secretary is During a public health emergency, the Secretary is authorized to activate and deploy willing members of the authorized to activate and deploy willing members of the Corps to areas of need, with the concurrence of state, Corps to areas of need, with the concurrence of state, local, or tribal officials. May also be activated as local, or tribal officials. May also be activated as intermittent employees of Public Health Serviceintermittent employees of Public Health Service FTCA, FECA, and USERRA coverageFTCA, FECA, and USERRA coverage Healthcare providers only need to be licensed in “a” stateHealthcare providers only need to be licensed in “a” state

Secretary may deploy select members without hiring and Secretary may deploy select members without hiring and pay travel or transportation expenses, including a per pay travel or transportation expenses, including a per diemdiem Such individuals are subject to the laws of the State in which Such individuals are subject to the laws of the State in which

their activities are undertaken their activities are undertaken

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Emergency System for Emergency System for Advance Registration of Advance Registration of

Volunteer Health Volunteer Health Professionals (ESAR-VHP)Professionals (ESAR-VHP)

National system of state-based programs that include: National system of state-based programs that include: recruitment, advance registration, licensure and credential recruitment, advance registration, licensure and credential verification, assignment of standardized credential levels, and verification, assignment of standardized credential levels, and mobilization of volunteers, PHS Act 319I mobilization of volunteers, PHS Act 319I

Inclusion in network does not constitute Federal appointmentInclusion in network does not constitute Federal appointment VHPs who register are generally not Federal employees, VHPs who register are generally not Federal employees,

although HHS could utilize certain emergency and temporary although HHS could utilize certain emergency and temporary hiring authorities to hire certain VHPs on a temporary basishiring authorities to hire certain VHPs on a temporary basis

In general, VHPS will not qualify for FTCA or FECA coverageIn general, VHPS will not qualify for FTCA or FECA coverage VHPs will need to obtain a license to practice across state VHPs will need to obtain a license to practice across state

lines unless there is a mechanism providing them with lines unless there is a mechanism providing them with reciprocityreciprocity

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Public Health Emergency Public Health Emergency (PHE) Declaration(PHE) Declaration

The Secretary may declare a PHE if he or she The Secretary may declare a PHE if he or she determines, after consultation with such public determines, after consultation with such public health officials as may be necessary, that (1) a health officials as may be necessary, that (1) a disease or disorder presents a public health disease or disorder presents a public health emergency; or (2) a public health emergency, emergency; or (2) a public health emergency, including significant outbreaks of infectious including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, diseases or bioterrorist attacks, otherwise exists, PHS Act 319PHS Act 319

TerminationTermination Secretarial determination that emergency no longer Secretarial determination that emergency no longer

exists or after 90 days, whichever occurs firstexists or after 90 days, whichever occurs first RenewalRenewal

May be renewed by the Secretary for additional 90 days May be renewed by the Secretary for additional 90 days periodsperiods

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Following a Declaration the Following a Declaration the Secretary May: Secretary May:

Access Public Health Emergency Fund Access Public Health Emergency Fund (when funds are available)(when funds are available)

Consistent with other authorities, make Consistent with other authorities, make grants, provide awards for expenses, and grants, provide awards for expenses, and enter into contracts and conduct and enter into contracts and conduct and support investigations support investigations

Extend deadlines, waive sanctions for Extend deadlines, waive sanctions for submission of data or reportssubmission of data or reports

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Support Other Support Other Discretionary Actions by Discretionary Actions by

the Secretary: the Secretary: Waive certain Medicare, Medicaid and CHIP Waive certain Medicare, Medicaid and CHIP

requirements (including temporary waiver of requirements (including temporary waiver of EMTALA), SSA 1135EMTALA), SSA 1135

Waive certain HIPAA sanctions for 72 hours, SSA 1135Waive certain HIPAA sanctions for 72 hours, SSA 1135 Declare an emergency justifying emergency use of an Declare an emergency justifying emergency use of an

investigational product, FFDCA 564investigational product, FFDCA 564 Waive certain requirements for medical Waive certain requirements for medical

countermeasure distribution, FFDCA 505-1countermeasure distribution, FFDCA 505-1 Exempt select agent requirements, PHS Act 351AExempt select agent requirements, PHS Act 351A Appoint temporary personnel, waive dual compensation Appoint temporary personnel, waive dual compensation

reduction, 5 C.F.R. 213.3102(i)(1), 5 U.S.C. 8344, 8468 reduction, 5 C.F.R. 213.3102(i)(1), 5 U.S.C. 8344, 8468 Adjust Medicare payment for Part B drugs, SSA 1847AAdjust Medicare payment for Part B drugs, SSA 1847A Waive of Ryan White HIV/AIDS requirements, PHS Act Waive of Ryan White HIV/AIDS requirements, PHS Act

XXVIXXVI

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Waiver under Section 1135 Waiver under Section 1135 of the Social Security Act of the Social Security Act

(SSA)(SSA) Waiver authority can be used to waive or modify Waiver authority can be used to waive or modify

certain Medicare, Medicaid, and CHIP certain Medicare, Medicaid, and CHIP requirements applicable to health care providersrequirements applicable to health care providers

Enumerated requirements can be waived or Enumerated requirements can be waived or modifiedmodified Conditions of participation, program participation Conditions of participation, program participation

requirements, certification requirementsrequirements, certification requirements EMTALA sanctionsEMTALA sanctions Stark self referral sanctionsStark self referral sanctions Certain HIPAA sanctionsCertain HIPAA sanctions Deadlines and timetables for the performance of required Deadlines and timetables for the performance of required

activities (can be modified only, not waived)activities (can be modified only, not waived) Requirements that healthcare providers hold licenses in Requirements that healthcare providers hold licenses in

the State in which they provide services (for the purposes the State in which they provide services (for the purposes of Medicare, Medicaid, and CHIP only) of Medicare, Medicaid, and CHIP only)

OtherOther

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1135 Waiver Authority1135 Waiver Authority Both a Presidential declaration under the Both a Presidential declaration under the

Stafford Act or the National Emergencies Act Stafford Act or the National Emergencies Act and a HHS Secretarial declaration of a public and a HHS Secretarial declaration of a public health emergency must be made to trigger health emergency must be made to trigger section 1135 authoritysection 1135 authority

Applies only in the “emergency area” during Applies only in the “emergency area” during the “emergency period”the “emergency period”

Emergency area is the geographic area Emergency area is the geographic area covered by the two triggering declarationscovered by the two triggering declarations

Emergency period is:Emergency period is: End of Presidential declaration;End of Presidential declaration; End of public health emergency declaration; OREnd of public health emergency declaration; OR 60 days from the date the waiver is published60 days from the date the waiver is published

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1135 Waiver Authority1135 Waiver Authority Waivers of HIPAA sanctions and non-pandemic Waivers of HIPAA sanctions and non-pandemic

related waivers of sanctions under EMTALA related waivers of sanctions under EMTALA are generally limited to a 72 hour period are generally limited to a 72 hour period beginning upon implementation of a hospital beginning upon implementation of a hospital disaster protocoldisaster protocol

HIPAA and EMTALA waivers are not effective HIPAA and EMTALA waivers are not effective for actions that discriminate among individuals for actions that discriminate among individuals on the basis of payment source or ability to payon the basis of payment source or ability to pay

When a public health emergency involves When a public health emergency involves pandemic infectious disease, waivers of pandemic infectious disease, waivers of EMTALA sanctions can extend through the EMTALA sanctions can extend through the duration of the public health emergencyduration of the public health emergency

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PHE/1135 RequestsPHE/1135 Requests Unlike Stafford Act declarations that ordinarily require a Unlike Stafford Act declarations that ordinarily require a

formal request by a state Governor, there is no statutory formal request by a state Governor, there is no statutory requirement that a Governor or other entity make a requirement that a Governor or other entity make a formal request for a PHE declaration or an 1135 waiverformal request for a PHE declaration or an 1135 waiver However, Governors may wish to make a formal request to HHS However, Governors may wish to make a formal request to HHS

for a PHE/1135 waiverfor a PHE/1135 waiver When state officials believe that a PHE and 1135 When state officials believe that a PHE and 1135

waivers are needed, they usually work with their HHS waivers are needed, they usually work with their HHS Regional Emergency Coordinator and regional CMS Regional Emergency Coordinator and regional CMS officials to discuss their requestofficials to discuss their request

When the Secretary of HHS issues an 1135 waiver, When the Secretary of HHS issues an 1135 waiver, generally hospitals and other entities need to work with generally hospitals and other entities need to work with HHS Regional CMS officials who will facilitate CMS’ HHS Regional CMS officials who will facilitate CMS’ granting of specific waiver requests on a case-by-case granting of specific waiver requests on a case-by-case basis. basis.

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Strategic National Strategic National StockpileStockpile

Secretary of HHS, in coordination with the Secretary of HHS, in coordination with the Secretary of Homeland Security, and consultation Secretary of Homeland Security, and consultation with Director, CDC, maintains a stockpile of drugs, with Director, CDC, maintains a stockpile of drugs, vaccines, and other biological products, medical vaccines, and other biological products, medical devices, and other supplies in such numbers, types, devices, and other supplies in such numbers, types, and amounts determined by the Secretary of HHS to and amounts determined by the Secretary of HHS to be appropriate and practicable to provide for the be appropriate and practicable to provide for the emergency health security of the United States, emergency health security of the United States, including the emergency health security of children including the emergency health security of children and other vulnerable populations, PHS Act 319F-2and other vulnerable populations, PHS Act 319F-2

ASPR exercises the responsibilities and authorities ASPR exercises the responsibilities and authorities of the Secretary with respect to coordination of the of the Secretary with respect to coordination of the Strategic National Stockpile (SNS), PHS Act 2811Strategic National Stockpile (SNS), PHS Act 2811

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Stockpile DeploymentStockpile Deployment

As required by Secretary of Homeland As required by Secretary of Homeland Security to respond to an actual or Security to respond to an actual or potential emergencypotential emergency

At the discretion of HHS Secretary to At the discretion of HHS Secretary to respond to an actual or potential public respond to an actual or potential public health emergency or other situation in health emergency or other situation in which deployment is necessary to protect which deployment is necessary to protect public health and safety public health and safety

Domestic and foreign deployments that Domestic and foreign deployments that meet statutory criteriameet statutory criteria

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Emergency Use of Emergency Use of Investigational Drugs Investigational Drugs

(EUA)(EUA) The Secretary may authorize use of unapproved The Secretary may authorize use of unapproved

new drugs, unlicensed biological products, or new drugs, unlicensed biological products, or unapproved/not cleared medical devices to unapproved/not cleared medical devices to respond to an emergency involving a chemical, respond to an emergency involving a chemical, biological, radiological, or nuclear agentbiological, radiological, or nuclear agent

Serious or Life-Threatening Disease or Serious or Life-Threatening Disease or ConditionCondition

Reasonable to believe product may be effective, Reasonable to believe product may be effective, known and potential benefits outweigh potential known and potential benefits outweigh potential risks, no adequate, approved, available risks, no adequate, approved, available alternative alternative

Applies to unapproved products and unapproved Applies to unapproved products and unapproved uses of approved products, FFDCA 564uses of approved products, FFDCA 564

44

EUA Process EUA Process Determination by DHS Secretary of an actual or Determination by DHS Secretary of an actual or

significant potential for domestic emergency significant potential for domestic emergency involving heightened risk of attack with a involving heightened risk of attack with a specified chemical, biological, radiological, or specified chemical, biological, radiological, or nuclear (CBRN) agent, nuclear (CBRN) agent, oror

Determination by DOD Secretary of an actual Determination by DOD Secretary of an actual or significant potential for military emergency or significant potential for military emergency involving a heightened risk to US military forces involving a heightened risk to US military forces of attack with a specified CBRN agent; of attack with a specified CBRN agent; oror

Determination by the HHS Secretary under Determination by the HHS Secretary under section 319 of the PHS Act of a public health section 319 of the PHS Act of a public health emergency that actually or potentially affects emergency that actually or potentially affects national security and involves a specified CRBN national security and involves a specified CRBN agentagent

45

EUA ProcessEUA Process HHS Secretary declares emergency justifying HHS Secretary declares emergency justifying

EUA EUA Specifies CBRN agent and productSpecifies CBRN agent and product Different from a PHE under section 319 of the PHS Different from a PHE under section 319 of the PHS

ActAct Different from a PREP Act declarationDifferent from a PREP Act declaration

FDA Commissioner Issues EUAFDA Commissioner Issues EUA Disease or conditions for which product may be Disease or conditions for which product may be

used to diagnose, prevent, or treatused to diagnose, prevent, or treat Secretary’s findings regarding known and potential Secretary’s findings regarding known and potential

risks and benefits, safety, potential effectiveness risks and benefits, safety, potential effectiveness and assessment of available scientific evidenceand assessment of available scientific evidence

Required conditions, additional conditionsRequired conditions, additional conditions Federal Register Notice of Declarations, EUAsFederal Register Notice of Declarations, EUAs

46

EUA DurationEUA Duration

Secretary’s Declaration terminates Secretary’s Declaration terminates in one year or when circumstances in one year or when circumstances justifying the EUA cease to existjustifying the EUA cease to exist May be renewedMay be renewed

FDA Authorization lasts until FDA Authorization lasts until Secretary’s declaration terminates Secretary’s declaration terminates or authorization is revoked if criteria or authorization is revoked if criteria for authorization no longer are metfor authorization no longer are met May be renewedMay be renewed

47

Public Readiness and Public Readiness and Emergency Preparedness Emergency Preparedness

(PREP) Act(PREP) Act Authorizes Secretary to issue a declaration Authorizes Secretary to issue a declaration

to provide immunity from tort liability to provide immunity from tort liability (except for willful misconduct) for claims:(except for willful misconduct) for claims: Death; physical, mental, emotional injury, illness, Death; physical, mental, emotional injury, illness,

disability, condition, fear thereof; medical disability, condition, fear thereof; medical monitoring, property damage, loss, business monitoring, property damage, loss, business interruption interruption

Causally related to development, distribution, Causally related to development, distribution, administration or use of “covered administration or use of “covered countermeasures”countermeasures”

Against “covered persons”, PHS Act 319F-3Against “covered persons”, PHS Act 319F-3 Authorizes emergency fund in U.S. Treasury Authorizes emergency fund in U.S. Treasury

for compensation for injuries from covered for compensation for injuries from covered countermeasures, PHS Act 319F-4countermeasures, PHS Act 319F-4

48

Covered Covered CountermeasuresCountermeasures

Qualified Pandemic or Epidemic ProductQualified Pandemic or Epidemic Product drug, biological product, device against pandemic or drug, biological product, device against pandemic or

epidemic disease (or against adverse effects of such epidemic disease (or against adverse effects of such drugs, biological products, or devices)drugs, biological products, or devices)

Approved, licensed, or under Emergency Use Approved, licensed, or under Emergency Use Authorization (EUA), Investigational Drug (IND) or Device Authorization (EUA), Investigational Drug (IND) or Device (IDE) application(IDE) application

Security CountermeasureSecurity Countermeasure Drug, biological product device against harm from Drug, biological product device against harm from

biological, chemical, radiological or nuclear agent (or biological, chemical, radiological or nuclear agent (or against adverse effects of such drugs, biological products, against adverse effects of such drugs, biological products, or devices)or devices)

Necessary to protect public healthNecessary to protect public health Approved, cleared, licensed, qualify for approval or Approved, cleared, licensed, qualify for approval or

licensing within eight years of federal procurement, EUA, licensing within eight years of federal procurement, EUA, IND, or IDEIND, or IDE

Product Authorized under EUAProduct Authorized under EUA

49

Covered PersonsCovered Persons ManufacturersManufacturers DistributorsDistributors Program Planners (State, local Program Planners (State, local

government, tribe, others who supervise government, tribe, others who supervise or administer countermeasure programs)or administer countermeasure programs)

Qualified Persons (licensed health Qualified Persons (licensed health professionals and others identified by the professionals and others identified by the Secretary who prescribe, administer, or Secretary who prescribe, administer, or dispense countermeasures)dispense countermeasures)

United StatesUnited States Officials, Agents, Employees of all of the Officials, Agents, Employees of all of the

aboveabove

50

Secretary’s DeclarationSecretary’s Declaration Considers desirability of encouraging design, Considers desirability of encouraging design,

development, clinical testing, investigation, development, clinical testing, investigation, manufacture, labeling, distribution, formulation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administering, donation, dispensing, prescribing, administering, licensing, use of countermeasure, and other licensing, use of countermeasure, and other relevant factorsrelevant factors

Determines that disease, health condition, or threat Determines that disease, health condition, or threat to health constitutes a public health emergency or to health constitutes a public health emergency or a credible risk of future health emergencya credible risk of future health emergency

Recommends manufacture, testing, development, Recommends manufacture, testing, development, distribution, administration or use of distribution, administration or use of countermeasurescountermeasures

States liability immunity in effect for recommended States liability immunity in effect for recommended activitiesactivities

51

Declaration ContentsDeclaration Contents

Category of diseases, health conditions, or Category of diseases, health conditions, or health threats for which administration health threats for which administration and use of countermeasure is and use of countermeasure is recommended;recommended;

Effective time periodEffective time period Population receiving countermeasurePopulation receiving countermeasure Geographic area of administration and useGeographic area of administration and use Any limitations on distributionAny limitations on distribution Any additional qualified personsAny additional qualified persons

52

LimitationsLimitations Willful misconductWillful misconduct Countermeasures used and Countermeasures used and

administered outside conditions of administered outside conditions of declarationsdeclarations

Claims not causally relatedClaims not causally related Claims filed in foreign jurisdictionsClaims filed in foreign jurisdictions Claims other than tort liabilityClaims other than tort liability Countermeasures obtained through non-Countermeasures obtained through non-

voluntary means (government program voluntary means (government program planners only; current declarations only)planners only; current declarations only)

53

Current DeclarationsCurrent Declarations Pandemic Influenza Vaccines, 72 Fed. Reg. 4710, Pandemic Influenza Vaccines, 72 Fed. Reg. 4710,

67731 73 Fed. Reg. 61871 67731 73 Fed. Reg. 61871 Pandemic Influenza Antivirals, 73 Fed. Reg. 61861Pandemic Influenza Antivirals, 73 Fed. Reg. 61861 Anthrax Countermeasures, 73 Fed. Reg. 58239Anthrax Countermeasures, 73 Fed. Reg. 58239 Botulinum Toxin Countermeasures, 73 Fed. Reg. Botulinum Toxin Countermeasures, 73 Fed. Reg.

6186461864 Acute Radiation Countermeasures, 73 Fed. Reg. Acute Radiation Countermeasures, 73 Fed. Reg.

6186661866 Smallpox Countermeasures, 73 Fed. Reg. 61689Smallpox Countermeasures, 73 Fed. Reg. 61689 Pandemic Influenza Diagnostics, Personal Pandemic Influenza Diagnostics, Personal

Respiratory Protection Devices, and Respiratory Respiratory Protection Devices, and Respiratory Support Devices, 73 Fed. Reg. 78362Support Devices, 73 Fed. Reg. 78362

54

Contact InformationContact Information

Jennifer E. RayJennifer E. RayOffice of the General CounselOffice of the General CounselDepartment of Health and Human ServicesDepartment of Health and Human Services202/205-9360 202/205-9360 Jennifer.Ray@hhs.govSusan E. ShermanSusan E. ShermanOffice of the General CounselOffice of the General CounselDepartment of Health and Human ServicesDepartment of Health and Human Services202/619-0166 202/619-0166 Susan.Sherman@hhs.gov

5656

Social Distancing Measures Social Distancing Measures Used Used

to Quench Epidemicsto Quench Epidemics Non-pharmaceutical interventionsNon-pharmaceutical interventions

““Snow day” restrictions (e.g., shelter-in-place)Snow day” restrictions (e.g., shelter-in-place) Close schools, daycare centersClose schools, daycare centers Cancel large public gatherings (e.g., concerts, Cancel large public gatherings (e.g., concerts,

theaters)theaters) Limit other public contacts (e.g., markets, public Limit other public contacts (e.g., markets, public

transit)transit) Encourage selected / non-essential workers to stay Encourage selected / non-essential workers to stay

homehome Implement telecommuting to minimize economic Implement telecommuting to minimize economic

impactimpact

5757

Isolation and QuarantineIsolation and Quarantine

““Isolation refers to the separation of Isolation refers to the separation of persons who persons who have a specific infectious have a specific infectious illnessillness from those who are healthy and from those who are healthy and the restriction of their movement to the restriction of their movement to stop the spread of that illness. . .”stop the spread of that illness. . .”

““Quarantine refers to the separation Quarantine refers to the separation and restriction of movement of persons and restriction of movement of persons who, while not yet ill, who, while not yet ill, have been have been exposedexposed to an infectious agent and to an infectious agent and therefore may become infectious.”therefore may become infectious.”

5858

Quarantine Objective:Quarantine Objective:Reduce Transmission of Reduce Transmission of

DiseaseDisease Effectiveness depends onEffectiveness depends on

Time period between exposure Time period between exposure and onset of communicabilityand onset of communicability

Mode of transmissionMode of transmission Actual distance of separation Actual distance of separation

requiredrequired Treatment optionsTreatment options Options for isolating patients Options for isolating patients

when in communicable statewhen in communicable state

59

Federal Federal Quarantine/IsolationQuarantine/Isolation

““Qualifying Disease listed in Exec. Qualifying Disease listed in Exec. OrderOrder

cholera, diphtheria, infectious TB, plague, cholera, diphtheria, infectious TB, plague, smallpox, yellow fever, viral hemorrhagic smallpox, yellow fever, viral hemorrhagic fevers (Ebloa), SARS, and pandemic fevers (Ebloa), SARS, and pandemic influenzainfluenza

Two separate reg parts: Part 70 = Two separate reg parts: Part 70 = domestic interstate quarantine and domestic interstate quarantine and Part 71 = travelers seeking entryPart 71 = travelers seeking entry

Court Order Court Order notnot necessary necessary

6060

Quarantine and Quarantine and Isolation:Isolation:

Constitutional Constitutional RequirementsRequirements Quarantine and isolation restrict individual Quarantine and isolation restrict individual

libertyliberty Similar to criminal arrest or civil commitment Similar to criminal arrest or civil commitment

U.S. Constitution, 5U.S. Constitution, 5thth and 14 and 14thth Amendments Amendments 55th th Due Process Clause: “nor be deprived of life, liberty, Due Process Clause: “nor be deprived of life, liberty,

or property, without due process of law”or property, without due process of law” 1414thth Amendment makes “due process” applicable to states Amendment makes “due process” applicable to states

Basic Due Process for quarantine and Basic Due Process for quarantine and isolation isolation Right to noticeRight to notice Right to counsel at certain stagesRight to counsel at certain stages Right to hearing on request Right to hearing on request Reasonable belief for detentionReasonable belief for detention

61

Federal Federal Quarantine/IsolationQuarantine/Isolation

DomesticDomesticCurrent RegulationsCurrent Regulations Somewhat VagueSomewhat Vague CDC acts when Interstate or local CDC acts when Interstate or local

control inadequate control inadequate Impose travel permits Impose travel permits Require interstate travelers to report to Require interstate travelers to report to

local PH Dept.local PH Dept. Order quarantine, isolation to prevent Order quarantine, isolation to prevent

disease spreaddisease spread No express due process provisionsNo express due process provisions

62

Federal Federal Quarantine/IsolationQuarantine/Isolation

DomesticDomesticProposed RegulationsProposed Regulations Adds definitions, same disease list, same Adds definitions, same disease list, same

Interstate Interstate Disease must be at “qualifying stage” Disease must be at “qualifying stage”

Precommunicable but likely to cause PH emergency or Precommunicable but likely to cause PH emergency or communicable communicable

““Provisional quarantine” up to 3 daysProvisional quarantine” up to 3 days Hearing after 3 days with hearing officer, no right to Hearing after 3 days with hearing officer, no right to

lawyerlawyer Quarantine - duration based on incubation Quarantine - duration based on incubation

& communicability periods& communicability periods Habeas petition, counsel attaches, admin exhaustionHabeas petition, counsel attaches, admin exhaustion

Forced medical exams, treatmentForced medical exams, treatment

6464

Legal Readiness: Legal Readiness: HearingsHearings

Recognized need: systems for large number of Recognized need: systems for large number of hearing requests in event of mass quarantinehearing requests in event of mass quarantine Service of processService of process Court-appointed counsel if habeas Court-appointed counsel if habeas

In-person vs. electronic / telephonic hearingsIn-person vs. electronic / telephonic hearings United States v. CrawfordUnited States v. Crawford Protecting hearing officers, courts and participantsProtecting hearing officers, courts and participants

Documentation and affidavitsDocumentation and affidavits Ancillary legal challenges Ancillary legal challenges

Business disruption, TROs, injunctionsBusiness disruption, TROs, injunctions

6565

Hearings and Modern Hearings and Modern Isolation Procedures Can Isolation Procedures Can

Be RigorousBe RigorousConfinement for Treatment:Confinement for Treatment: Best v. Bellevue HospitalBest v. Bellevue Hospital, New York (2004), New York (2004)

Non-infectious TB patient confined when sought to leave Non-infectious TB patient confined when sought to leave hospital and refused to cooperate with treatmenthospital and refused to cooperate with treatment

Filed suit against health department and hospitalsFiled suit against health department and hospitals Was Mr. Best dangerous to himself and community?Was Mr. Best dangerous to himself and community? Did Mr. Best have adequate right to hearing?Did Mr. Best have adequate right to hearing?

Health department prevailedHealth department prevailed But only after 4 hearings and 7 administrative and state But only after 4 hearings and 7 administrative and state

and federal judicial orders over 2 yearsand federal judicial orders over 2 years

6767

Quarantine and Quarantine and IsolationIsolation::

Obligations to Those Obligations to Those ConfinedConfined Basic needs Basic needs

Food, medical care, safety and sanitary Food, medical care, safety and sanitary needsneeds

Separation of isolated from Separation of isolated from quarantined personsquarantined persons

Medical treatment during confinementMedical treatment during confinement Habitable accommodationHabitable accommodation Protection from known threatsProtection from known threats

Religious and dietary considerationsReligious and dietary considerations

6969

State and Local State and Local Jurisdictional Issues Jurisdictional Issues

Regarding Protection of Regarding Protection of PeoplePeople Remember: Police powers, Remember: Police powers,

including public health including public health authority, are reserved to states authority, are reserved to states under the U.S. Constitution’s under the U.S. Constitution’s 1010thth Amendment Amendment

But: federal and international But: federal and international jurisdictional issues may arise in jurisdictional issues may arise in a given casea given case

7070

Federal Jurisdictional Federal Jurisdictional IssuesIssues

Current federal statute (PHS Act Current federal statute (PHS Act Sec. 361) was enacted in an era Sec. 361) was enacted in an era when immigrants arrived by seawhen immigrants arrived by sea

Designed to control international importation Designed to control international importation and interstate spread of certain diseasesand interstate spread of certain diseases

Not designed to prevent infectious persons Not designed to prevent infectious persons bound for other countries from leaving U.S. bound for other countries from leaving U.S.

Requires that specific quarantinable Requires that specific quarantinable diseases be listed in a Presidential diseases be listed in a Presidential Executive OrderExecutive Order

7171

Federal Powers: Federal Powers: Quarantine and IsolationQuarantine and Isolation

The Secretary of HHS (through CDC) The Secretary of HHS (through CDC) can:can: ““detain, medically examine, or detain, medically examine, or

conditionally release” persons suspected of conditionally release” persons suspected of carrying certain communicable diseases carrying certain communicable diseases

Authority applies only if communicable Authority applies only if communicable disease has been designated in a disease has been designated in a Presidential Executive OrderPresidential Executive Order SARS added 2003SARS added 2003 Avian influenza added 2005Avian influenza added 2005

7272

Scope of Federal Scope of Federal Quarantine PowerQuarantine Power

Interstate / International - persons entering:Interstate / International - persons entering: Into the U.S. or possessions from foreign Into the U.S. or possessions from foreign

countriescountries From one state or possession into any other From one state or possession into any other

state or possessionstate or possession,, BUT ALSO: BUT ALSO: Within a state, if individual is reasonably Within a state, if individual is reasonably

believed to be infectedbelieved to be infected If state / local disease control measures are If state / local disease control measures are

inadequate to control spread of diseaseinadequate to control spread of disease close coordination between state and CDC is close coordination between state and CDC is

criticalcritical

7373

Federal QuarantineFederal Quarantine::Enforcement FlexibilityEnforcement Flexibility

Sec. 311 of PHS ActSec. 311 of PHS Act:: HHS authorized to HHS authorized to accept state and local assistance in accept state and local assistance in enforcing federal quarantine orderenforcing federal quarantine order

Also, HHS can assist states and political Also, HHS can assist states and political subdivisions in enforcing their subdivisions in enforcing their quarantines quarantines

U.S. military may assist enforcement of U.S. military may assist enforcement of state quarantine at seaportsstate quarantine at seaports Note: this is an exception to the normal Note: this is an exception to the normal

prohibition on the use of military for domestic prohibition on the use of military for domestic law enforcementlaw enforcement

7474

SARS Lessons from CanadaSARS Lessons from Canada Communications in Toronto “demystified” Communications in Toronto “demystified”

quarantinequarantine Hotlines staffed by 80 nurses received 300,000 Hotlines staffed by 80 nurses received 300,000

callscalls Community meetings were held Community meetings were held Information posted on websites in 14 languagesInformation posted on websites in 14 languages

Substantial “social cohesion” prevailedSubstantial “social cohesion” prevailed Over 30,000 “voluntary” quarantines took placeOver 30,000 “voluntary” quarantines took place Only 27 formal quarantine orders neededOnly 27 formal quarantine orders needed

The sole appeal was withdrawnThe sole appeal was withdrawn

7575

Lessons from Canada: Lessons from Canada: ComplianceCompliance

Despite substantial voluntary compliance Despite substantial voluntary compliance in Toronto during the 2003 SARS in Toronto during the 2003 SARS outbreak, important detracting factors outbreak, important detracting factors were identified:were identified: Lost wages or income of those quarantinedLost wages or income of those quarantined Groceries and essential servicesGroceries and essential services Boredom of persons sheltering at homeBoredom of persons sheltering at home

Good communication was an essential Good communication was an essential factor in encouraging voluntary factor in encouraging voluntary compliance with the public health orderscompliance with the public health orders

7676

International Health International Health Regulations (IHR)Regulations (IHR)

Following 2003 SARS, the World Health Following 2003 SARS, the World Health Organization (WHO) revised the Organization (WHO) revised the International Health RegulationsInternational Health Regulations

IHR contain operational definition of a IHR contain operational definition of a “public health emergency of international “public health emergency of international concern” that triggers increased control concern” that triggers increased control responsibilities for nationsresponsibilities for nations

7777

International Health International Health Regulations (IHR)Regulations (IHR)

The WHO has no free-standing The WHO has no free-standing international quarantine authorityinternational quarantine authority Quarantine is still a country-by-country Quarantine is still a country-by-country

powerpower

The revised IHR preserve the important The revised IHR preserve the important WHO roles of collecting international WHO roles of collecting international outbreak information from various outbreak information from various sources and of issuing “traveler sources and of issuing “traveler advisories” when appropriate advisories” when appropriate

78

Questions?Questions?

79

ConclusionConclusion

For more information on For more information on public health emergency law, public health emergency law,

please visit CDC’s Public please visit CDC’s Public Health Law Program Website Health Law Program Website

at:at:

www.cdc.gov/phlp.www.cdc.gov/phlp.