Source: http://www2.cdc.gov/phlp/emergencyprep/FPHELfaq.asp
Timestamp: 2015-05-24 13:12:17
Document Index: 239229587

Matched Legal Cases: ['§ 247', '§ 247', '§ 264', '§ 264', '§ 2680', '§2860']

CDC - Frequently Asked Questions about Federal Public Health Emergency Law - Emergency Legal Preparedness Clearinghouse - PHLP
This report presents information in the form of "answers" to 37 questions about principal federal laws that shape response to public health emergencies. The information presented in this report is based on the April 28, 2009, teleconference "Federal Public Health Emergency Law: Implications for State & Local Preparedness and Response" and was compiled by the Public Health Law Program Centers for Disease Control and Prevention
The contents of this report have not been formally disseminated by the Centers for Disease Control and Prevention and should not be construed to represent any agency determination or policy. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. It is important to note that the contents of this document are for informational purposes only and are not intended to be a substitute for professional legal or other advice. While every effort has been made to verify the accuracy of these materials, legal authorities and requirements may vary across jurisdictions, and laws are often updated and amended. Always seek the advice of an attorney or other qualified professional with any questions you may have. Legal Authorities
Primarily, HHS authorities flow from the Public Health Service Act (PHSA) that was enacted in 1944 and has been amended many times since then. According to the PHSA, the Secretary of HHS "shall lead all Federal public health and medical response to public health emergencies and incidents covered by the National Response [Framework]." HHS is the primary agency for Emergency Support Function (ESF) 8 under the National Response Framework, which covers public health and medical response. HHS is also a support agency for ESF 6, covering mass care, emergency assistance, housing, and human services. Section 311 of the PHSA provides the Secretary of HHS with authority to extend temporary assistance to states or localities to meet health emergencies at the request of states or local authorities, including utilizing HHS personnel, equipment, medical supplies and other resources, when state resources are overwhelmed by an emergency situation. HHS also requires funding and resources to respond to other emergency events. While Section 311 gives HHS broad authority to assist a state or locality during an emergency, if a Stafford Act declaration is issued by the President, HHS would generally do so under a Mission Assignment from FEMA. The Secretary may authorize assistance regardless of a formal declaration of a public health emergency or a Stafford Act declaration. Additional authority comes from the Federal Food, Drug, and Cosmetic Act when relevant to emergency response as well as Social Security Act authorities.
In 1950, the first public law was passed creating a federal disaster relief program. The Robert T. Stafford Disaster Relief and Emergency Assistance Act (The Stafford Act), amending the Disaster Relief Act of 1974, was passed in 1988 and functions as one of the primary disaster relief legal authorities. The Stafford Act authorizes the President to issue a major disaster or an emergency declaration in response to an event (or threat) that overwhelms state or local government. The governor of an affected 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 magnitude of the emergency exceeds the state's capability. Declaration under the Stafford Act triggers access to disaster relief funds as appropriated by Congress. The fund has several billion dollars to be immediately available for the emergency needs of states and local governments. The Stafford Act also authorizes the Federal Emergency Management Agency (FEMA) to coordinate administering all of the disaster relief to the states. 3. What is the purpose and function of the Pandemic and All-Hazards Preparedness Act?
The Pandemic and All-Hazards Preparedness Act passed in 2006 amends the PHSA and identifies the Secretary of HHS as the lead federal official for public health emergency preparedness and response and also establishes the HHS Assistant Secretary for Preparedness and Response (ASPR). The ASPR serves as the Secretary of HHS's principle advisor on matters related to public health and medical emergency preparedness. The act also provides new authorities for development of countermeasures and establishes mechanisms and grants to continue strengthening of state and local public health security infrastructure and addresses surge capacity by placing the National Disaster Medical System under the purview of HHS.
Causally related to administration or use of "covered countermeasures" including design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use
Against "covered persons"
Waive or modify certain requirements: Under Section 1135 of the SSA, the Secretary may waive or modify certain requirements of Medicare, Medicaid, State Children's Health Insurance Program (CHIP) and Health Insurance Portability and Accountability Act (HIPAA) as necessary to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in SSA programs and that providers of such services in good faith who are unable to comply with certain statutory requirements are reimbursed and exempted from sanctions for noncompliance, absent fraud or abuse.
Adjust Medicare reimbursement for certain Part B drug: In the case of a public health emergency in which there is a documented inability to access drugs and biologicals and a associated increase in the price of a drug or biological that is not reflected in the manufacturer's average sales price (ASP) for one or more quarters, the Secretary may use the wholesale acquisition cost or other reasonable measure of drug or biological price instead of the manufacturer's ASP. The substituted price or measure may be used until the price of the drug or biological has stabilized and is substantially reflected in the manufacturer's ASP.
Section 1135 waivers are authorized by the Social Security Act and are applicable only in the 'emergency area' during the 'emergency period' as outlined in the declarations. An emergency area and period is where and when there is: a) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Stafford Act, and b) a public health emergency declared by the Secretary. The waiver lists types of requirements that can be waived or modified to assist states in providing surge capacity such as waiver or modification of bed limits for critical access hospitals. When the Secretary issues an 1135 waiver, hospitals and other entities usually work with HHS Regional Centers for Medicare and Medicaid Services (CMS) officials to seek specific waivers or modifications on a case-by-case basis.
Requirements that physicians and other health care professionals hold licenses in the state in which they provide services if they have a license from another state and are not affirmatively barred from practice in that state or any state in the emergency area (note however, that this waiver is for the purposes of Medicare, Medicaid, and CHIP reimbursement only – states determine whether a non-federal provider is authorized to provide services in the state without state licensure).
Sanctions under EMTALA for redirection of an individual to another location to receive a medical screening examination pursuant to a state emergency preparedness plan, or in the case of a public health emergency involving a pandemic infectious disease, a state pandemic preparedness plan, or for transfer of an individual who has not been stabilized if the transfer is necessitated by the circumstances of the emergency. A waiver of EMTALA sanctions is effective only if actions under the waiver do not discriminate on the basis of a patient's source of payment or ability to pay. EMTALA waivers are subject to special time limits.
Sanctions and penalties arising from noncompliance with HIPAA privacy regulations relating to: a) obtaining a patient's agreement to speak with family members or friends or honoring a patient's request to opt out of the facility directory, b) distributing a notice of privacy practices, or c) the patient's right to request privacy restrictions or confidential communications. The waiver of HIPAA requirements is effective only if actions under the waiver do not discriminate on the basis of a patient's source of payment or ability to pay. These HIPAA waivers under are subject to special time limits.
When the Secretary issues an 1135 waiver, HHS automatically waives such sanctions and penalties described in the 1135 waiver in the emergency area for 72 hours beginning when a hospital disaster protocol is implemented. The waiver of HIPAA requirements is effective only if actions under the waiver do not discriminate on the basis of a patient's source of payment or ability to pay. Also, the waiver only applies if the hospital has implemented its hospital disaster protocol. The HIPAA sanctions and penalties that may be waived when an 1135 waiver is issued are specified in the 1135 waiver document and do not waive HIPAA in its entirety. Even without an 1135 waiver, there are various flexibilities and exceptions that may apply to permit covered entities to share protected health information during a public health emergency. See the HHS Web page Emergency Preparedness Planning and Response (http://www.HHS.gov/ocr/hipaa/emergencyPPR.html) for more information about the application of HIPAA during public health emergencies (whether or not the Secretary makes a formal public health emergency declaration under section 319 of the PHSA, or issues an 1135 waiver). Waivers or modifications under section 1135 of the SSA may be retroactive to the beginning of the emergency period (or to any subsequent date). The waiver or modification terminates either upon termination of the emergency period or 60 days after the waiver or modification is first published (subject to 60-day renewal periods until termination of the emergency). However, waivers of EMTALA (except in the case of a pandemic disease) or HIPAA requirements are effective only for 72 hours beginning on implementation of a hospital disaster protocol. A waiver of EMTALA sanctions in connection with an emergency involving a pandemic disease (such as pandemic influenza) is effective until the termination of the pandemic-related public health emergency. However, a particular waiver or modification will terminate prior to the ultimate termination date described in this paragraph (e.g., prior to the 72 hour time period after a hospital begins to implement its disaster protocol) if the Secretary determines that as of an earlier date, the waiver or modification is no longer necessary to accomplish the purposes set forth in Section 1135(a). Public Health Emergency Procedures
10. What is a public health emergency and how is a declaration of public health emergency made?
Under Section 319 of the Public Health Services Act (42 U.S.C. § 247d), the Secretary may declare a public health emergency if the Secretary 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." The broad definition gives HHS discretion to determine if a particular event constitutes a public health emergency. A public health emergency declaration lasts for 90 days and can be terminated earlier if the Secretary determines the emergency no longer exists. It can also be renewed by the Secretary for additional 90 day periods if the emergency continues to exist. 11. May the Secretary declare a "potential" public health emergency?
The Secretary 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. For example, the Secretary may declare a public health emergency based on emergency needs that exist preceding the outbreak of disease or in anticipation of a storm before a hurricane makes landfall. The statutory language in section 319 of the PHSA, however, does not explicitly use the term "potential" public health emergency.
The President may declare an emergency without the request of a governor if the emergency involves "federal primary responsibility" (such as if the event occurs on federal property, for example the bombing of the Murrah Federal Building in 1995). Alternatively, the President may issue a declaration of federal primary responsibility for public health issues that are a joint state and federal responsibility and not primarily federal responsibility.
The Homeland Security Act was passed in 2002 and moved FEMA, a previously independent agency, to the Department of Homeland Security where it is today. In response to Hurricane Katrina, the Post Katrina Emergency Management Reform Act was passed on October 4, 2006 changing FEMA's authority and mission. The updated mission of FEMA 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." FEMA works with state, local, and tribal governments, emergency response providers, other federal agencies, and the private sector.
Under 42 U.S.C. § 247d-6b, the HHS Secretary, in coordination with the Secretary of Homeland Security, and in consultation with the CDC Director, maintains a stockpile of drugs, vaccines, and other biological products, as well as medical devices and other supplies in such numbers, types, and amounts as 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. ASPR exercises the responsibilities and authorities of the Secretary with respect to coordination of the Strategic National Stockpile. Items in the SNS can be deployed by the Secretary of Homeland Security to respond to an actual or potential emergency or by the 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. The declaration of a public health emergency is not required to deploy the stockpile and contents can be deployed in advance of a public health emergency.
States have laws that authorize quarantine and isolation to control the spread of communicable diseases based on the state's police power authority to protect the health, safety, and welfare of its citizens. These laws can vary from state to state and can be broad or specific. In some states, local health authorities are empowered to implement quarantine and isolation based on state law. Federal quarantine and isolation authority is limited, to those communicable diseases specified in an executive order of the President, i.e., "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 (SARS), and influenza caused by novel or reemerging influenza viruses that are causing, or have the potential to cause, a pandemic.
Under section 361 of the Public Health Service Act, CDC may apprehend, examine, detain, or conditionally release persons with certain communicable diseases that are listed in an Executive Order of the President, i.e., "quarantinable diseases." This includes the authority to quarantine and isolate persons to prevent the spread of these diseases. (42 U.S.C. § 264), Also under 42 U.S.C. § 264, 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 pre-communicable stage, but only if the disease would be likely to cause a public health emergency if transmitted to other individuals. Additionally, the Director must reasonably believe that the individual is moving or about to move from one state into another or constitutes a probable source of infection to other individuals, who while infected with such disease in its qualifying stage, will be moving from one state into another. If such individuals are found to be infected, they may be detained as reasonably necessary.
It is well recognized that freedom from physical restraint is a liberty interest protected by the due process clauses of the Fifth and Fourteenth amendments to the United States Constitution. In general, due process includes the following elements: reasonable and adequate notice of the action that the government is taking, typically through a written order; an opportunity to be heard on a timely basis, typically through some form of hearing or other proceeding; access to legal counsel; and review of the government's actions by an impartial decision-maker. 28. What is CDC's role with respect to quarantine and isolation?
Public health authorities at the federal, state, or local level may sometimes seek help from police or other law enforcement officers to enforce a public health order. Under the Public Health Service Act, United States Customs and Border Protection (CBP) and the United States Coast Guard (USCG) are required to assist CDC in enforcing its quarantine regulations. In most jurisdictions, violating a quarantine or isolation order is punishable by fines and/or imprisonment. Workforce Issues
30. Who are essential service providers and what access are they allowed during an emergency situation?
According to Section 427 of the Stafford Act (42 U.S.C. 5189e), the head of a federal agency "may not deny or impede access to the disaster site to an essential service provider whose is necessary to restore and repair an essential service." Essential service providers include municipal, nonprofit, or private for-profit entities that provide telecommunications service, electrical power, natural gas, water and sewer services or any other essential service as determined by the President.
When healthcare personnel are deployed across state lines, licensing, workers compensation, and liability concerns may arise. At the state and federal levels, liability and licensure are covered by a patchwork of different sources, some of which are addressed here. The Federal Tort Claims Act (FTCA), (28 USC 2672 and 1346(b)), provides that the United States shall be liable for the negligence of its officers and employees while acting within the scope of their employment, in the same manner as a private person would be liable to a claimant under the laws of the state where the injury occurred. In other words, the FTCA covers claims for property damage or personal injury or death caused by the negligence, wrongful act, or omission of a federal employee acting within the scope of his/her employment. The FTCA coverage applies as long as the act is considered part of the employee's official duties and the action in question is within the scope of employment. Obviously, therefore, the FTCA would not apply to any activities undertaken outside of the employee's official duties as a federal employee. The FTCA, however, does not provide relief to all claims arising out of the actions of government employees acting in the scope of employment. Exceptions to the FTCA, provided in 28 U.S.C. § 2680, include, for example, any claim arising in a foreign country. (28 U.S.C. §2860(k)) The Federal Employees' Compensation Act (FECA, 5 USC 8101 et seq.), provides compensation benefits to civilian employees of the United States for disability due to personal injury sustained by the employee while in the performance of work-related duties. In other words, for example, if a federal employee sustains an injury to himself/herself while operating his/her own personal vehicle in the course of business/scope of employment, FECA would apply. Benefits will not be paid, however, if the injury is caused by the willful misconduct of the employee or by the employee's intention to bring about his or her injury, or if intoxication (by alcohol or drugs) is the proximate cause of the injury. Many states have provisions for some sort of liability protection for healthcare providers. State Good Samaritan statutes may offer liability protection to healthcare workers but differ by states in terms of breath of coverage. The Federal Volunteer Protection Act and certain state volunteer protection acts may provide liability protection for healthcare providers. The Emergency Management Assistance Compact (EMAC), 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 Acts is a model law that addresses liability and licensing and has been adopted by ten states thus far. 33. What HHS personnel groups are eligible to be deployed in an emergency?
The United States Public Health Service Commissioned Corps is one of the seven American uniformed services and is tasked with delivering public health promotion and disease prevention programs. Commissioned Corps officers hold positions of leadership in the Department of Health and Human Services as well as other government offices and agencies. According to its website, the Commissioned Corps may be deployed to "provide urgently needed public health and clinical expertise in response to large-scale local, regional and national public health emergencies and disasters." The Office of the Surgeon General oversees the Commissioned Corps. The Inactive Reserve Corps (IRC) is comprised of public health professionals who may be called to short or long tours of active duty with the Commissioned Corps as needed, most often to provide critical coverage during staffing shortages such as in times of disaster or emergency.
The Medical Reserve Corps (MRC) is comprised of volunteer civilian practicing and retired physicians, nurses and other public health workers formed mainly at the community level. The purpose of the MRC is to address the community's ongoing health needs as well as to assist the community during a large scale emergency. Willing MRC volunteers can be activated and deployed by the Secretary to assist with federal response and recovery efforts. HHS maintains sensitivity to not deploy those needed in their own communities. If MRC members are activated as intermittent employees of the public health service, they will be provided coverage for liability and workers compensation, and will have license reciprocity as if they were a federal employee. MRC members activated as intermittent employees are also covered under the Uniform Services Employment and Re-Employment Rights Act (USERRA) which protects the reserve components of our uniformed services so individuals who are deployed do not lose their pre-deployment jobs.
The National Disaster Medical System (NDMS) is a coordinated effort of the Department of Homeland Security, the Department of Defense, the Veteran's Administration, and the Department of Health and Human Services in collaboration with states, localities, and private entities. NDMS Response Teams can be deployed to provide health services; health related social services, and other appropriate human services (such as veterinary or mortuary services) to respond to the needs of victims of a public health emergency and to be present where and when the Secretary determines location is at risk of a public health emergency. Activation and deployment of NDMS teams does not require a formal public health emergency declaration. NDMS members are intermittent employees of the public health service. When they are activated they are federal employees and have FTCA tort liability coverage and FECA workers' compensation coverage. NDMS also covered under the Uniform Services Employment and Re-Employment Rights Act (USERRA) which protects the reserve components of our uniformed services so individuals who are deployed do not lose their pre-deployment jobs. 37. How are healthcare providers who provide assistance during an emergency licensed and registered?
ASP–Average Sales Price
ASPR–Assistant Secretary for Preparedness and Response
CHIP–Children's Health Insurance Program
EMTALA–Emergency Medical Treatment and Active Labor Act
ESF–Emergency Support Function
ESAR-VHP–Emergency System for Advanced Registration of Volunteer Health Professionals
EUA–Emergency Use Authorization
FEMA–Federal Emergency Management Agency FFDCA–Federal Food, Drug, and Cosmetic Act HHS–United States Department of Health and Human Services HIPAA–Health Insurance Portability and Accountability Act
NDMS–National Disaster Management System
PHSA–Public Health Service Act
PREP Act–Public Readiness and Emergency Preparedness Act
REMS–Risk Evaluation and Mitigation Strategies
SNS–Strategic National Stockpile
SSA–Social Security Act
USERRA–Uniform Services Employment and Re-Employment Rights Act
On April 26, 2009, the Acting Secretary of the federal Department of Health and Human Services (HHS) issued a nationwide public health emergency declaration in response to human infections from influenza A (H1N1) virus. In addition, the World Health Organization raised the level of influenza pandemic alert to the highest level on June 11, 2009. The HHS declaration was renewed by HHS Secretary Kathleen Sebelius on July 24, 2009. Local and state health agencies are the first line of preparedness for infectious disease pandemics and other threats to the health of the public. Their success hinges on many factors, including, their "legal preparedness," that is, their understanding of and capacity to use, laws and legal authorities that support effective response. Those legal authorities are complex and involve laws at the federal, state, local, and Tribal levels. Further, they are found in multiple sectors, including not only the public health sector but also such sectors as emergency management, health care, law enforcement, education, and transportation.
Because a number of federal laws relevant to public health emergencies had been revised in recent years, in the spring of 2009 CDC's Public Health Law Program and invited four senior federal attorneys to update public health practitioners and counsel on current, pertinent federal laws in a 90-minute teleconference on April 28, 2009. By coincidence, the teleconference "Federal Public Health Emergency Law: Implications for State and Local Preparedness and Response" took place at the beginning of a novel influenza A (H1N1) pandemic. The faculty highlighted provisions of federal law especially relevant to that new threat. Following the presentation, members of the large audience – more than 1,300 public health and other professionals – focused many of their questions on issues related to the pandemic.
This report – Frequently Asked Questions about Federal Public Health Emergency Law – is derived from the April 28 program and the dialogue between the faculty and participants that followed. The questions and answers are organized in four categories: legal authorities, public health emergency procedures, isolation and quarantine issues, and workforce issues.
The CDC Public Health Law Program provides many additional resources on public health emergency legal preparedness accessible in the "CDC Public Health Emergency Legal Preparedness Clearinghouse" at http://www.cdc.gov/phlp:
· Up-to-date information on legal issues and resources related to infectious disease outbreaks
· The training curricula Public Health Emergency Law 3.0 and Forensic Epidemiology 3.0
· The Social Distancing Law Assessment Template
· The Menu of Suggested Provisions for Public Health Mutual Aid Agreements and companion Inventory of Mutual Aid Agreements and Related Provision"
· A three-part portfolio of resources for improved coordination across public health, law enforcement, the judiciary, and the corrections sector, and · The National Action Agenda for Public Health Legal Preparedness