Public health emergency law: a primer for leaders and managers in the military.
(Laws, regulations and rules)
Medical law (Interpretation and construction)
Topinka, Joseph B.
|Publication:||Name: U.S. Army Medical Department Journal Publisher: U.S. Army Medical Department Center & School Audience: Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2012 U.S. Army Medical Department Center & School ISSN: 1524-0436|
|Issue:||Date: Jan-March, 2012|
|Topic:||Event Code: 930 Government regulation; 940 Government regulation (cont); 980 Legal issues & crime Advertising Code: 94 Legal/Government Regulation Computer Subject: Government regulation|
|Product:||Product Code: 9104111 Active Military Personnel; 9105280 Health Regulation NAICS Code: 92811 National Security; 92615 Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors|
|Organization:||Government Agency: United States. Army; United States. Department of Defense|
|Geographic:||Geographic Scope: United States Geographic Code: 1USA United States|
On March 5, 2010, the Department of Defense (DoD) reissued DoD Instruction 6200.03, Public Health Emergency Management Within the Department of Defense} This comprehensive instruction addresses various subjects including public health emergency management roles and responsibilities for military commanders, as well as roles for military treatment facility (MTF) commanders, public health emergency officers, and MTF emergency managers. It also provides DoD guidance in accordance with applicable law. This article summarizes some of the major laws and provides a basic legal foundation for leaders and/or managers facing a public health emergency.
THE STAFFORD ACT
While this article's purpose is not to address DoD support to civil authorities, we cannot address public health legal authorities without first discussing the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act). (2) The Act allows the President to declare a major disaster or an emergency in response to an event (or threat) that overwhelms state or local government (to include a public health emergency). Ideally, the governor of a state must first respond to the disaster and execute the state's emergency plan before requesting that the President declare a major disaster or emergency, and the governor must certify that the emergency is in excess of the state's ability to handle it. But a governor's request is not necessary for the President to issue an emergency declaration if the emergency involves a federal primary responsibility, which is a situation where an emergency involves a subject area for which the United States exercises exclusive or preeminent responsibility and authority, such as a federal government building.
This declaration is vital in that it triggers access to federal disaster relief funds as appropriated by Congress, funds that can be used for many needs including:
* Public assistance, to include emergency work and permanent work to assist states, local government, and certain private, nonprofit organizations.
* Individual assistance, such as direct and financial assistance to individuals for housing and other disaster-related needs.
* Hazard mitigation to assist state 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.
* Emergency work to assist in meeting threats to life and property.
* Permanent work to repair, restore, and replace damaged facilities owned by state and local governments and eligible private nonprofit organizations.
A critical aspect of the Act is that the fund has several billion ([10.sup.9]) dollars which may be immediately available for the emergency needs of state and local governments as appropriated by Congress in the Disaster Relief Fund. * Thus, from a fiscal law perspective, Disaster Relief Funds are only limited to those purposes authorized by the Stafford Act. The Act authorizes the Federal Emergency Management Agency (FEMA) to administer all disaster relief to the states.
PUBLIC HEALTH EMERGENCY DECLARATION
The Secretary of Health and Human Services can declare a public health emergency under Section 319 of the Public Health Services Act (3) (hereinafter referred to as Section 319), if the Secretary determines that:
* a disease or disorder presents a public health emergency; or
* a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists.
Such a broad definition gives the Secretary a great amount of flexibility. The Secretary also has the discretion to determine that a disease or condition presents a public health emergency, or a public health emergency otherwise exists, based on conditions that exist prior to the actual outbreak of disease or natural catastrophe. A public health emergency declaration lasts for 90 days, but can be terminated earlier if the Secretary determines that the emergency no longer exists. It can also be renewed by the Secretary for additional 90-day periods if the emergency persists.
A Presidential declaration under the Stafford Act and the public health declaration (PHD) under Section 319 are distinct and separate declarations, although often confused as being one and the same. One does not require the other, but in some situations, both are required in order for the Secretary to exercise certain additional authorities not otherwise provided under Section 319. For example, both a Presidential declaration under the Stafford Act (or the National Emergencies Act, 150 USC [section][section]1621, 1631) and a PHD are required for the Secretary to waive or modify certain requirements under Section 1135 of the Social Security Act. (4) Once both are in place, the Secretary can waive or modify bed limits for critical access hospitals; and certain sanctions contained in the Emergency Medical Treatment and Active Labor Act (5) and the Health Insurance Portability and Accountability Act. (6)
In general, there is no requirement for a formal request to have such a declaration made by the Secretary. After a PHD has been issued, the Secretary has broad authority, including making grants, entering into contracts, conducting and supporting investigations, and accessing the Public Health Emergency Fund if appropriated by Congress. In addition, the Secretary has broad legal authority to provide assistance to state and local governments in the absence of a PHD, such as deploying the Strategic National Stockpile in advance of a public health emergency. Still, a PHD is a requirement for other authorities of the Secretary. One in particular involves emergency use authorization (EUA) of investigational medications. Under the Project Bioshield Act, (7) when the Secretary has made a PHD, the Food and Drug Administration may issue an EUA to allow the use of unapproved new drugs, off-label use of drugs approved for other purposes, unlicensed biological products, or medical devices not yet approved for the emergency. When the Secretary declares a PHD, the DoD "shall, to the extent practicable, act consistently with the applicable provisions of the declaration." (1(p5))
The Office of Personnel Management (OPM) develops regulations and federal job descriptions. They normally require a federal civilian healthcare employee to be licensed in any state. OPM determines qualifications and verifies those qualifications. Public health emergencies do not waive or preempt state licensing requirements for these employees.
The Federal Tort Claims Act (FTCA) (8) covers claims for property damage or personal injury or death caused by the negligence, wrongful act, or omission of a federal (military or civilian) employee acting within the scope of his/her employment. The FTCA coverage applies to an employee's official duties when the employee's actions in question are within the scope of employment. The FTCA does not apply to activities conducted outside the employee's official duties as a federal employee.
The Federal Employees' Compensation Act (FECA) (9) provides compensation benefits to federal civilian employees for disability due to personal injury sustained by an employee while in the performance of work-related duties. Benefits will not be paid, however, if the injury is caused by the willful misconduct or by the employee's intention to bring about his or her injury, or if intoxication is the proximate cause of the injury.
Overseas, the Foreign Claims Act (10) and the Military Claims Act, (11) as well as the North Atlantic Treaty Organization (NATO) Status of Forces Agreement (in accordance with the International Agreements Claims Act (12)) address issues of liability.
The Emergency System for Advanced Registration of Volunteer Health Professionals (ESAR-VHP) * is a system for advanced registration of healthcare providers developed by the Department of Health and Human Services to verify licensure, assign standardized credential levels, track hospital privileges, and mobilize volunteers. Registration with ESAR-VHP does not, in and of itself, constitute federal employment. Registration with ESAR-VHP does not qualify a public health professional for coverage under FTCA or FECA, and does require an additional mechanism for license reciprocity. However, upon declaration of an emergency, DoD Instruction 6200.031 does allow MTF commanders to supplement the available staff of healthcare personnel with volunteers, using information and documentation from the ESAR-VHP. Such volunteers are considered employees of the DoD. (1(p29))
For nonfederal employees, many states have provisions for some sort of liability protection for nonfederal healthcare providers. For example, Good Samaritan statutes may offer liability protection to healthcare workers, but differ by states in terms of breadth of coverage. The Federal Volunteer Protection Act (13) and certain state volunteer protection acts may provide liability protection for healthcare providers. The Emergency Management Assistance Compact, (14) of which all states are members, provides immunity to state officers and employees that other states share with an affected state pursuant to the compact. The Uniform Emergency Volunteer Health Practitioners Act * is a model law that addresses liability and licensing, but it has not been adopted by all states.
ISOLATION AND QUARANTINE
In general, under the police powers of the 10th Amendment to the US Constitution, the states have primary authority, including public health authority, for controlling the spread of communicable diseases within their borders. However, jurisdictional issues may arise when the spread of communicable diseases goes beyond state borders. Under Section 361 of the Public Health Services Act, (3) the Centers for Disease Control and Prevention (CDC) may apprehend, examine, detain, or conditionally release persons with certain communicable diseases that are listed by an executive orders In addition, the CDC may apprehend and examine individuals traveling from one state into another if the CDC Director reasonably believes that such individuals may be infected with a quarantinable disease in its qualifying stage. A qualifying stage means that the disease is in a communicable stage, or a precommunicable stage, but only if the disease would be likely to cause a public health emergency if transmitted to other individuals. (15) Federal regulations governing quarantine and isolation are found in the Code of Federal Regulations at 42 CFR[section][section]70 and 71. Part 70 governs interstate quarantine and isolation, while Part 71 deals with quarantine and isolation of foreign persons or imports into the United States or its possessions. Part 71 does not apply to isolation and quarantine in foreign lands, but rather addresses protection against the introduction, transmissions, and spread of communicable disease from foreign countries into the United States or its possessions.
In general, isolation is the separation of an individual or group infected and/or suspected to be infected with a communicable disease from those who are healthy, in such a place and manner to prevent the spread of that disease. (1(p37)) Quarantine deals with the separation of an individual or group that has been exposed to a communicable disease, but is not yet ill, from others who have not been so exposed, in such manner and place to prevent the possible spread of the communicable disease. (1(p38)) Both involve the restriction of the freedom of movement, a liberty interest protected by the due process clauses of the 5th and 14th Amendments to the US Constitution. Due process includes reasonable and adequate notice of the action that the government is taking, an opportunity to be heard on a timely basis, access to legal counsel, and review of the government's actions by an impartial decision-maker. DoD Instruction 6200.03 (1) attempts to meet these due process requirements by ensuring that every individual or group subject to quarantine (and presumably isolation as well) is provided written notice of the reason for the quarantine and plan of examination, testing, and/or treatment designed to resolve the reason for the quarantine. The individual or group is allowed to provide information supporting an exemption or release. The military commander or designee shall review such information, and they will exercise independent judgment and promptly render a written decision on the need for the continued quarantine. Individuals and groups subject to the quarantine shall be advised that violators may be charged with a crime and subject to punishment of a fine or imprisonment for not more than one year. (16) In the case of military personnel, these potential sanctions are in addition to applicable actions by military legal authorities.
Command authority in terms of a public health emergency has historically been a vague yet powerful concept. DoD Instruction 6200.03 (1) has attempted to define that authority. One aspect of that authority involves the declaration of a public health emergency within the scope of the commander's authority and the implementation of relevant emergency health powers to achieve the greatest public health benefit while maintaining operational effectiveness. This authority will cover military personnel but may also include persons other than military personnel who are present on a DoD installation or in areas under DoD control. According to Enclosure 3 of DoD Instruction 6200.03 (-1pp15-25)):
Emergency Health Powers many include:
(a) Collecting specimens and performing tests on any property or on any animal or disease vector, living or deceased, as reasonable and necessary for emergency response.
(b) Closing, directing the evacuation of, or decontaminating any asset or facility that endangers public health; decontaminating or destroying any material that endangers public health; or asserting control over any animal or disease, living or deceased, vector that endangers public health.
(c) Using facilities, materials, and services for purposes of communications, transportation, occupancy, fuel, food, clothing, health care, and other purposes, and controlling or restricting the distribution of commodities as reasonable and necessary for emergency response.
(d) Controlling evacuation routes on, and ingress and egress to and from, the affected DoD installation and/or military command.
(e) Taking measures to safely contain and dispose of infectious waste as may be reasonable and necessary for emergency response.
(f) Taking measures reasonable and necessary, pursuant to applicable law, to obtain needed health care supplies, and controlling use and distribution of such supplies.
(g) Directing US military personnel to submit to a medical examination and/or testing as necessary for diagnosis or treatment. Persons other than military personnel may be required as a condition of exemption or release from restrictions of movement to submit to a physical examination and/or testing as necessary to diagnose the person and prevent the transmission of a communicable disease and enhance public health and safety. Qualified personnel shall perform examinations and testing.
(h) Restricting movement to prevent the introduction, transmission, and spread of communicable diseases and/ or any other hazardous substances that pose a threat to public health and safety. In the case of military personnel, restrictions of movement, including isolation, or any other measure necessary to prevent or limit transmitting a communicable disease and enhance public safety may be implemented. In the case of persons other than military personnel, restrictions of movement may include isolation or limiting ingress and egress to, from, or on a DoD installation and/or military command.
(i) Isolating individuals or groups to prevent the introduction, transmission, and spread of a communicable disease and/or any other hazardous substances that pose a threat to public health and safety. Isolation measures may be implemented in health care facilities, living quarters, or other buildings on a DoD installation and/or military command. Isolation measures do not lessen the responsibilities of the Military Health System (MHS) to provide medical care to infected and/or affected persons to the standard of care feasible given resources available.
Because of the scope and variance among the laws in the various foreign countries in which the United States has military personnel, no attempt will be made here to discuss the particularities of dealing with a public health emergency in any specific country. Instead, a general overview is provided with citations to resources to assist in the creation of solid preparations and plans for a particular area of operations.
The greatest challenge for those working and stationed in foreign countries is that most of the authorities previously stated in this article do not apply. FEMA has no authority in foreign lands. There is no access to the Disaster Relief Fund (however, Overseas Humanitarian, Disaster, and Civic Assistance funds may be available to pay for humanitarian assistance operations and activities authorized by 10 USC [section]2651 and other authority). Information and resources are presented in the Figure.
With the possible exception of the land upon which our US embassies are situated, we typically have no "federal jurisdiction" on foreign soil. DoD Instruction 6200.031 does, however, apply to DoD facilities located both within the geographic United States and in foreign countries, but it clearly cautions that the instruction is limited in application for those outside of the United States:
It is, therefore, imperative for all leaders, managers, and legal advisors to be intimately familiar with the host nation's public health emergency laws, protocols, and procedures. The Department of State is the lead federal agency for requests for assistance originating outside of DoD. Commands and their public health emergency officers will closely coordinate with both the host nation authorities and the Department of State.
Although there is a tendency to defer all legal issues in public health emergency law to the medical attorneys, to do so is a grave oversight. In overseas locations in particular, the scope of potential legal issues grows exponentially. Potential legal issues arising out of a broad scope public health emergency are, but are not limited to:
Contracts--failures of host nation contractors to comply with or complete contracts for fear of exposure; because of quarantine or isolation limitations; because of loss of capability due to involvement in the emergency (illness, deaths, or tasked for higher priority missions). For example, consider the implications of food delivery to dining facilities and commissaries which is halted for any of the above reasons.
Legal Assistance--wills, powers of attorney, etc. But consider also the special requirements necessary to accommodate a sudden rise in the number of widows/widowers and orphans, abandoned property, retirees needing assistance, etc.
Labor Law--employees unable or unwilling to perform their duties; employees being required to work outside of their scope of employment; addressing volunteers, overtime, etc.
International Law--addressing issues pertaining to host nation employees; access to our installations; movement of personnel, property, etc; addressing concerns of US personnel living off installations; dealing with criminal sanctions against US personnel in host nation courts for failures to comply with host nation law.
Medical Law--examples include addressing issues of emergency health powers, emergency use authorizations, standards of care, Health Insurance Portability and Accountability Act (HIPAA)6 and temporary waiver of HIPAA sanctions, medical malpractice, medical credentialing/privileging, etc.
Status of forces agreements (SOFAs) should be carefully reviewed to determine what language addresses public health emergencies. Article 53A of the German Supplement to the NATO SOFA, for example, provides that local, host nation, authorities may "regulate to protect health on US forces' installations." It is imperative that individuals have an advanced understanding as to how the respective host nation authorities interpret such words. Keep in mind, however, that SOFAs do not apply to US civilians not accompanying the forces (for example, expatriate US residents abroad), contractors, US civilians vacationing in the foreign country, or third country military personnel on leave (however, those on temporary duty may be covered).
Finally, perhaps the most useful resource is the International Health Regulations (IHRs),17 developed by the World Health Assembly in 2005, which establishes an international legal framework to provide for a public health response to the international spread of disease. The IHRs constitute an international legal instrument that is binding on 194 countries across the globe, including all World Health Organization member states. The revised IHRs, which entered into force as international law on June 15, 2007, provide the legal framework to
The IHRs have provisions for procedures at international airports and ports, refusal of entry quarantines, and tracing of contacts in times of emergency. Every leader and lawyer involved in public health emergency planning should avail themselves of this useful resource and determine its applicability within their host nation(s).
All leaders and managers in the DoD should be familiar with DoD Instruction 6200.03. (1) It is a critical tool in planning for a public health emergency. In addition, they need to have a solid understanding of the federal laws which are behind this instruction; some of which have been addressed in this article. Ultimately, reacting to a public emergency will be a team approach. The authors have some parting recommendations to leaders and managers as you plan for dealing with a public health emergency:
1. Become familiar with the CDC's Frequently Asked Questions about Federal Public Health Emergency Law (available at http://www2a.cdc.gov/phlp/emergencyprep/ FPHELfaq.asp). It is a comprehensive collection of easily located, specific information on subjects covered in this article, and more.
2. Know your supporting legal counsel and establish a relationship early on. Train with counsel. Incorporate him/her into your exercises and your real-life situations.
3. Have a basic understanding of the legal framework both in the military and civilian environment. Even though this article has addressed federal, state, local, and, overseas legal issues, host nation issues may arise as well. In other words, what happens outside the military installation's gate must not be ignored. Cooperation with local leaders and managers in a public health emergency is critical.
4. Get the facts before making any decisions. The law is only as good as the facts to which the law is applied. Incomplete facts will result in incomplete and possibly detrimental decisions and negative public health consequences.
(1.) Department of Defense Instruction 6200.03: Public Health Emergency Management Within the Department of Defense. Washington, DC: US Dept of Defense; March 5, 2011. Available at: http://www. dtic.mil/whs/directives/corres/pdf/620003p.pdf.
(2.) 42 USC [section][section]5121-5207.
(3.) 42 USC [section]247d
(4.) 42 USC [section]1320b-5.
(5.) 42 USC [section]1395dd.
(6.) Pub L No 104-191, 110 Stat 1936.
(7.) 21 USC [section]360bbb-3.
(8.) 28 USC [section][section]2672-2680, [section]1346(b).
(9.) 5 USC [section]81 et seq.
(10.) 10 USC [section]2734.
(11.) 10 USC [section]2733.
(12.) 10 USC [section]2734a, [section]2734b
(13.) 42 USC [section][section]14501-14505.
(14.) Pub L No 104-321.
(15.) 42 USC [section]264.
(16.) 42 USC [section]271 as implemented by 42 CFR, Part 71.2.
(17.) International Health Regulations. 2nd ed. Geneva, Switzerland: World HealthOrganization; 2005. Available at: http://www.who.int/ihr/9789241596664/en/ index.html. Accessed November 10, 2011.
MAJ Joseph B. Topinka, JAG, USA
Ida Agamy, JD
** The Stafford Act authorizes the President to issue a major disaster declaration to speed a wide range of federal aid to states determined to be overwhelmed by hurricanes or other catastrophes. Financing for the aid is appropriated to the Disaster Relief Fund (DRF), administered by the Department of Homeland Security. Funds appropriated to the DRF remain available until expended (a "no-year" account). The Stafford Act authorizes temporary housing, grants for immediate needs of families and individuals, the repair of public infrastructure, emergency communications systems, and other forms of assistance. Additional information at: http://www. fema.gov/pdf/about/stafford_act.pdf.
*** Information available at: http://www.phe.gov/esarvhp/pages/about.aspx.
([dagger]) Federal quarantine and isolation authority is limited to those communicable diseases specified in an executive order of the President, ie, "quarantinable diseases." The most current list is found in Executive Order 13295, as amended by Executive Order 13375. These quarantinable diseases include cholera, diphtheria, infectious tuberculosis, plague, smallpox, yellow fever, viral hemorrhagic fevers, severe acute respiratory syndrome, and influenza caused by novel or reemerging influenza viruses that are causing or have the potential to cause a pandemic.
The following US laws and regulations do not apply on foreign soil:
The Stafford Act, 42 USC [section][section]5121-5207 (2)
42 USC [section]5192
42 USC [section]5189e
42 USC [section]2811(b)(4)(B)
Homeland Security Act of 2002, Pub L 107-296
Executive Order 12148: Federal Emergency Management, July 20, 1979
42 USC [section]5170b
42 USC [section]5172
42 USC [section]311
44 CFR, Emergency Management and Assistance
Although not directly applicable to public health emergencies, good information and possible resources can be found by reviewing the Defense Threat Reduction Agency's Foreign Consequence Management Legal Deskbook, January 2007. Available at: http://www.dtra.mil/documents/business/current/FCMLegalDeskbook.pdf
Further Information Sources
Agreement Between the Parties to the North Atlantic Treaty Regarding the Status of their Forces, June 19, 1951 (NATO SOFA)
Agreement to Supplement the Agreement Between the Parties to the North Atlantic Treaty Regarding the Status of their Forces With Respect to Foreign Forces Stationed in the Federal Republic of Germany, August 3, 1959, revised effective March 29, 1998 (NATO SOFA Supplementary Agreement)
DoD Directive 5530.3: International Agreements, June 11, 1987, w/change 1, February 18, 1991
Chairman of the Joint Chiefs of Staff Instruction 2300.01C: International Agreements, March 15, 2006
Army Regulation 27-50: Status of Forces Policies, Procedures, and Information, December 15, 1989
Army Regulation 550-51: International Agreements, April 15, 1998
Rules for the Use of Force
Annex L (AT/FP Rules for the Use of Force) to Army in Europe Regulation 525-13: Antiterrorism (AT), November 15, 2005 (pending revision)
10 USC [section]404 [Foreign Disaster Assistance, 2004]
10 USC [section]2551 [Humanitarian Assistance, 2004]
DoD Directive 6200.3: Emergency Health Powers on Military Installations, May12, 2003
Dept of the Army Installation Management Directive 6200.3: Implementation of DoD Directive 62003.3, Emergency Health Powers on Military Installations, January 27, 2004
Specific to Europe and European Command areas of responsibility, but useful for reference
US European Command Directive 5-13, International Agreements, Authorities and Responsibilities, January 27, 1994
US European Command Directive 45-3, Foreign Criminal Jurisdiction over US Personnel, March17, 2001 Army in Europe Regulation 1-3, International and Other Agreements, December 22, 2005
Army in Europe Regulation 550-50, Exercise of Foreign Criminal Jurisdiction over US Personnel, January 31, 2001
Army in Europe Regulation 550-56, Exercise of Jurisdiction by German Courts and Authorities Over US Personnel, December 11, 2009
Army in Europe Regulation 27-3, Sending State Forces Activities and Coordination, September 22, 2008
Information and resources regarding the authority and/or applicability of laws and military regulations in foreign countries.
MAJ Topinka is Deputy Staff Judge Advocate, US Army Medical Command, Fort Sam Houston, Texas.
Ms Agamy is Deputy Command Judge Advocate, US Army Europe Regional Medical Command, Heidelberg, Germany.
In areas outside the United States, this Instruction applies to the extent it is consistent with local conditions, and the requirements of applicable treaties, agreements, and other arrangements with foreign governments and allied forces. Implementation of these provisions at non-US installations and field activities shall require formal agreements with host-nation authorities as well as allied and coalition forces. (1(p3))
... prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade. (17(p10))
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