Federal Public Health Emergency Law
Overview
The preservation of the public health has historically been the responsibility of state and local governments. Clarity in leadership is crucial in a joint federal, state, and local response to any event which could cause harm to the public's health. In an evaluation of the gaps in pandemic planning, a recent Government Accountability Office (GAO) report sited comments from interviews of federal and private sector representatives which expressed that a lack of clarity exists in the roles and responsibilities of federal and state governments on a number of issues. These gaps in clarity could hinder the ability of stakeholders to effectively respond to the needs of their jurisdictions. An influenza pandemic which may occur in waves and has no distinct boundaries requires a greater understanding of authorities and responsibilities. Federal government leadership roles and responsibilities for pandemic preparedness and response are evolving and involve shared responsibility between the Department of Homeland Security (DHS) and the Department of Health and Human Services (HHS). Once a federal declaration of emergency has been issued, state law will be preempted to the extent that they conflict with federal law. The following information is intended to provide the major relevant legal federal authorities associated with preparedness and response.
Federal Authorities for Preparedness and Response
The Public Health Service Act (PHSA), 42 U.S.C. §§ 201 et seq. (1994). The Secretary of Health and Human Services is authorized to develop and take necessary actions to implement a plan to control epidemics of any disease or condition and to meet other health emergencies and problems, (42 U.S.C. § 243). During an emergency proclaimed by the President, the President has broad authority to direct the services of the Public Health Service, (42 U.S.C. § 217). Under that section, the President is authorized to “utilize the [Public Health] Service to the extent and in such manner as shall in his judgment promote the public interest.”
- Research. Section 301 of the PHSA, 42 U.S.C. § 241, authorizes the Secretary to conduct and encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental impairments of man. The Secretary is also authorized to collect and make available through publications and other appropriate means, information as to, and the practical application of, such research and other activities.
- Public Health Emergency. Section 319(a) of the PHSA, 42 U.S.C. 247d, authorizes the Secretary of Health and Human Services to declare a public health emergency and “take such action as may be appropriate to respond” to that emergency consistent with his authorities. Appropriate action may include making grants, entering into contracts, and conducting and supporting investigation into the cause, treatment, or prevention of the disease or disorder that presents the emergency. The Secretary’s declaration also can be the first step in authorizing emergency use of unapproved products or approved products for unapproved uses under section 564 of the Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3), or waiving certain regulatory requirements of the Department, such as select agents requirements, or -- when the President also declares an emergency-- waiving certain Medicare, Medicaid, and State Children’s Health Insurance Program (SCHIP) provisions. Implementation Plan for the National Strategy for Pandemic Influenza 219 Appendix C - Authorities and References
- Vaccines and Therapeutics. The PHSA provides additional authorities for core activities of HHS that will be needed to plan and implement an emergency response. For example, sections 301, 319F-1, 402, and 405 of the PHSA authorize the Secretary of Health and Human Services to conduct and support research and development of vaccines and therapeutics. Section 351 of the PHSA and provisions of the Federal Food, Drug, and Cosmetics Act authorize the Secretary and the Food and Drug Administration (FDA) to regulate vaccine development and production. Infrastructure support for preventive health services such as immunization activities, including vaccine purchase assistance, is provided under section 317 of the PHSA.
- Liability Protection. Section 319F-3 of the PHSA provides immunity to manufacturers, distributors, program planners, “qualified persons,” and their employees for claims for loss caused by, arising out of, relating to, or resulting from the administration or use of any “covered countermeasure” that is the subject of a declaration made by the Secretary. A covered countermeasure is a drug, device, or biological that is (1) subject to an emergency use authorization under section 564 of the Federal Food Drug and Cosmetic Act, (2) used against an epidemic or pandemic and
either approved or subject to an IND, or (3) a security countermeasure as defined under the Project BioShield Act. Section 319F-4 allows the Secretary to, by declaration, establish an emergency fund in the Treasury which will be used to provide compensation for injuries directly caused by administration of a covered countermeasure.
- Strategic National Stockpile. Section 319F-2 of the PHSA authorizes the Secretary, in coordination with the Secretary of Homeland Security, to maintain the Strategic National Stockpile to provide for the emergency health security of the United States.
- Quarantine. Section 361 of the PHSA (42 U.S.C. § 264), authorizes the Secretary of Health and Human Services to make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States, or from one State or possession into any other State or possession. Implementing regulations are
found at 42 C.F.R. Parts 70 and 71. The HHS Centers for Disease Control and Prevention (CDC) administers these regulations as they relate to quarantine of humans. Diseases for which individuals may be quarantined are specified by Executive Order; the most recent change to the list of quarantinable diseases was Executive Order 13375 of April 1, 2005, which amended Executive Order 13295 by adding “influenza caused by novel or re-emergent influenza viruses that are causing, or have the potential to cause, a pandemic” to the list. CDC issued a new proposed rule updating these regulations on November 30, 2005. 70 Fed. Reg. 71892 (www.cdc.gov/ncidod/dq/nprm/index.htm). Other provisions in Title III of the PHSA permit HHS to establish quarantine stations, provide care and treatment for persons under quarantine, and provide for quarantine enforcement by specified components of DHS and cooperating State and local entities.
- Vaccine Development. Further, HHS has broad authority to coordinate vaccine development, distribution, and use activities under section 2102 of the PHSA, describing the functions of the
National Vaccine Program. The Secretary has authority for health information and promotion activities under title XVII and other sections of the PHSA. HHS can provide support to States and localities for emergency health planning under title III of the PHSA.
- National Goals. Under section 1701 of the PHSA, 42 U.S.C. § 300u, the Secretary is authorized to formulate national goals for health information, promotion, health services, and education 220 Implementation Plan for the National Strategy for Pandemic Influenza Appendix C - Authorities and References and to undertake activities, including training, support, planning, and technical assistance, to carry out those goals.
- Mobilizing the Commissioned Corps. Section 203 of the PHSA, 42 U.S.C. § 204, authorizes the Federal Government to mobilize officers of the United States Public Health Service Regular Commissioned Corps and the Reserve Commissioned Corps, including commissioned corps officers who are veterinarians, in times of emergencies.
- National Emergencies Act, 50 U.S.C. 1631 et seq., Declaration of national emergency by Executive order; authority; publication in Federal Register; transmittal to Congress.
- Social Security Act, 42 U.S.C. 1320b-5 et seq. Grants authority to the secretary to waive requirements of the Medicare, Medicaid, and State Children’s Health Insurance programs during national emergencies.
Chart provided by the U.S. Department of Homeland Security
Current as of 10/27/09
H1N1 Influenza Pandemic Emergency Authorities Matrix
| Public Health Emergency (PHE) |
Authority: SEC/HHS authorized to declare a Public Health Emergency under the PHSA, 42 U.S.C. § 247d.
Implementation: SEC/HHS declared a nationwide PHE for the H1N1 flu outbreak on 26 APR 09, and renewed it on 24 JUL 09 and 1 OCT 09.
Duration: 90 days or until SEC/HHS declares emergency no longer exists.
Geographical Restriction: A designated geographic area as specified in the declaration.
|
Relief Authorized without a PHE declaration:
HHS has broad authority under other sections of the PHS Act and other laws administered by HHS to assist states and other entities during an emergency even without a formal PHE declaration under section 319. For example, under section 311 of the PHS Act, the secretary may, at the request of a state or local authority, extend temporary assistance to states or localities to meet health emergencies that warrant federal assistance.14 Other examples include: promoting research and studies into the causes, diagnosis, treatment, control, and prevention of diseases under section 301 of the PHS Act; establishing isolation and quarantine under section 361 of the PHS Act; maintaining and deploying the Strategic National Stockpile under section 319F-2 of the PHS Act; and deploying National Disaster Medical System teams under section 2812 of the PHS Act and select members of the Medical Reserve Corps under section 2813 of the PHS Act.
Relief authorized under a PHE declaration (without either a National Emergency Act proclamation or Stafford Act Declaration):
SEC/HHS may take appropriate actions to respond to the emergency such as: making grants; entering into contracts;making temporary hiring appointments; conduct/support an investigation into the cause, treatment, or prevention of the disease or disorder; and make disbursements from the Public Health Emergency Fund. 42 U.S.C. § 247d.
The Secretary may grant extensions or waive sanctions relating to submission of data or reports required under HHS laws. A Public Health Emergency declaration can be a necessary step in enabling the secretary to take a variety of discretionary actions under other authorities to respond to the PHE. For example, she may: waive certain prescription and dispensing requirements; exempt for up to 30 days a person from select agents requirements; adjust Medicare reimbursement for certain Part B drugs; waive certain Ryan White HIV/AIDS grant program requirements; and declare an emergency justifying emergency use of an investigational product under section 564 of the Federal Food Drug and Cosmetic Act.
Relief authorized under a PHE declaration (when there is either National Emergency Act proclamation or a Stafford Act Declaration):
See next column describing National Emergencies Act.
|
| Addition of National Emergencies Act (NEA) Declaration to PHE |
Authority: POTUS may declare unilaterally a National Emergency under the NEA. 50 U.S.C. §§1601-1651. This NEA allows an important section of the PHSA to become effective, called HHS’s section 1135 waiver authority.
Implementation: POTUS declared a National Emergency on 23 OCT 09.
Duration: 1 year (declaration). “1135 waivers” issued by HHS under the Social Security Act generally last for the
duration of the public health emergency; HIPPA and nonpandemic related EMTALA waivers under section 1135 last 72 hours after a hospital implements its disaster response plan.
Geographical Restriction: None required by the National Emergencies Act. |
Relief authorized under the NEA alone:
None. See 50 U.S.C. § 1631. The NEA authorizes the President to declare a national emergency and activate existing statutory provisions that authorize the exercise of special or extraordinary power. The NEA is a procedural device—it does not provide any specific emergency authority on its own.
Relief authorized when NEA is coupled with a Public Health Emergency declaration:
Section 1135 of the Social Security Act [42 USC §1320b–5] permits the Secretary of Health and Human Services to waive certain regulatory requirements for healthcare facilities in response to emergencies. Two conditions must be met for the Secretary to be able to issue such “1135 waivers”: first, the Secretary must have declared a Public Health Emergency; second, the President must have declared a National Emergency either through a Stafford Act Declaration or National Emergencies act Declaration. If these conditions are met, then HHS may issue specific waivers or modifications under section 1135 in response to particular needs, and only within the geographic and temporal limits of the emergency declarations.
The Secretary will issue waivers or modifications under section 1135 for specific requirements to match the specific situational
needs. The requirements that may be waived include certain requirements related to Medicare, Medicaid or the Children’s
Health Insurance Program (CHIP), the Emergency Medical Treatment and Active Labor Act (EMTALA), and the Health
Insurance Portability and Accountability Act (HIPAA). These requirements provide important protections for patients during
normal day-to-day operations, but they may impede the ability of healthcare facilities to fully implement disaster operations
plans that enable appropriate care during emergencies. In addition, requirements under the Emergency Medical Treatment and Active Labor Act (EMTALA) prohibit hospitals from sending an individual to an off-campus location for an appropriate screening.
|
| Stafford Act - Emergency Declaration |
Authority: POTUS may declare an Emergency upon gubernatorial request or unilaterally if he determines the incident is within the primary responsibility of the U.S. Government, etc. 42 U.S.C. § 5191(b).
For emergency declaration requirements, see 44 C.F.R. 206.35.
Implementation: None to date.
Duration: As specified in the declaration.
Geographical Restriction: As specified in the declaration or as amended by FEMA. |
Assistance to States/ Localities and, Indirectly, to Individuals:
As specified in the new Disaster Assistance and Disaster Operations Fact Sheet on Pandemic Influenza 9580.106 signed 22 OCT 2009.
- Emergency Protective Measures (Category B) may be available from the federal government and its agencies and departments to assist state and local governments and certain private non-profit organizations. These include Category B Emergency Protective Measures for which the state will incur a 25% cost share. These measures include:
Emergency medical care (non-deferrable medical treatment of disaster victims in a shelter or temporary medical facility and
related medical facility services and supplies, including emergency medical transport, X-rays, laboratory and pathology services, and machine diagnostic tests); Temporary medical facilities (for treatment of disaster survivors when existing facilities are overloaded and cannot accommodate the patient load); Purchase and distribution of food, water, ice,
medicine, and other consumable supplies; Management, control, and reduction of immediate threats to public health
and safety (e.g., to include sanitizing eligible public facilities) ;Movement of supplies and persons; Security, barricades and
fencing, and warning devices; Congregate sheltering (for disaster survivors when existing facilities are overloaded and
cannot accommodate survivors’ needs); Communicating health and safety information to the public; Technical assistance to State and local governments on disaster management and control; Search and rescue to locate and recover members of the population requiring assistance, and to locate and recover human remains; and Recovery and disposal of animal carcasses (except if another federal authority funds the activity - e.g., U.S. Department of Agriculture, Animal, Plant and Health Inspection Service provides for removal and disposal of livestock).
|
NOTE: This matrix is a synopsis of the authorities discussed in it, and it is not intended to be used as comprehensive legal guidance.
Sources of States' Public Health Authority
The power of a state to protect the health of its people is derived from two inherent artifacts of the political sovereignty just noted: the police power, and the parens patriae power.There are two classes of membership in the Association. The classes are as follows:
- The Police Power - The "police power" is the power to promote the public safety, health, and morals by restraining and regulating the use of liberty and property. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996) ("Throughout our history the several States have exercised their police powers to protect the health and safety of their citizens. Because these are primarily, and historically, matters of local concern, the States traditionally have had great latitude under their police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons." (internal citations omitted)); BLACK’S LAW DICTIONARY 1196 (8`H ED. 2004); ERNST FREUND, THE POLICE POWER: PUBLIC POLICY AND CONSTITUTIONAL RIGHTS iii, 3 (1904). The police power supports the authority of a state to enact and enforce “health laws of every description.” Jacobson, supra, 197 U.S. at 25.
- The Parens Patriae Power - The parens patriae power is the power of the state to serve as guardian of persons under legal disability, such as juveniles or the insane. See Heller v. Doe, 509 U.S. 312, 332 (1993) (" [T]he state has a legitimate interest under its parens patriae powers in providing care to its citizens who are unable to care for themselves....") (internal citations omitted; BLACK'S LAW DICTIONARY 1144 (8th ed. 2004), and
- State Constitutional Powers- Authorities granted under each individual state constitution.
|