April 28, 2009 2:00-4:00pm EDT

1. Federal Public Health Emergency Law: Implications for State and Local Preparedness and ResponseA Facilitated Teleconference Sponsored by CDC’s Public Health Law Program and the Coordinating Office of Terrorism Preparedness and Emergency Response April 28, 2009 2:00-4:00pm 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 State’s 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 Governor’s 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 “[f]or necessary expenses in carrying out the . . . Stafford . . . Act.”   • Thus, the DRF’s 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

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 Secretary’s 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) – worker’s 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 state’s 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 • Secretary’s 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 • Secretary’s Declaration terminates in one year or when circumstances justifying the EUA cease to exist • May be renewed • FDA Authorization lasts until Secretary’s 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. Secretary’s 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