Legal Authority for Implementation of a Federal Public Health and Medical Services Response

The HHS Secretary has legal authority to take action under several statutes, including the Public Health Service Act, Federal Food, Drug and Cosmetic Act, Social Security Act, and the Robert T. Stafford Act.

The legal authority of the HHS Secretary for each of the following circumstances is:

Legal Authority without Declaration of a Public Health Emergency

The HHS Secretary is permitted the following actions without declaration of a Public Health Emergency

Establish quarantine
Maintain the Strategic National Stockpile (SNS)
Activate the U.S. Public Health Service (USPHS) Commissioned Corps
Maintain food and drug safety

Legal Authority with Declaration of a Public Health Emergency

The HHS Secretary is permitted the following actions when a Public Health Emergency is declared.

Make grants to State and local agencies
Provide awards for expenses
Enter into contracts
Conduct and support investigations into the cause, treatment, or prevention of the specific disease or disorder
Access funds appropriated to the Public Health Emergency Fund
Grant extensions or waive sanctions related to deadlines for submitting data or reports required by law
Exempt (for 30 days, subject to one 30 day renewal) an entity from requirements to respond to a domestic or foreign public health emergency that involves the select agent or toxin
Mobilize National Disaster Medical Systems (NDMS)
Make temporary appointments of personnel (up to one year or the duration of the emergency) to respond to the public health emergency
Waive dual compensation (salary offset) for temporarily re-employed annuitants during an emergency involving a direct threat to life or property or under other unusual circumstances
Declare an emergency under Section 564 of the Food, Drug, and Cosmetic Act to authorize emergency use of products still undergoing testing

Legal Authority When the President Declares a Major Disaster or an Emergency

When the President declares a major disaster or an emergency, the following two laws additionally affect emergency authorities of the HHS Secretary.

Robert T. Stafford Act
National Emergencies Act

The President may declare a major disaster under the Stafford Act when a natural catastrophe (i.e., hurricane, tornado, fire) causes damage of sufficient severity and magnitude that effective response is beyond State and local capabilities. The Stafford Act also authorizes an emergency declaration to provide Federal assistance to supplement State and local efforts and capabilities to save lives, protect property, promote public health and safety, and/or lessen or avert the threat of a catastrophe.

The Stafford Act authorizes a multitude of Federal agency actions in response to a major disaster or emergency, such as the following:

Issuance of warnings
Mobilization of emergency support teams
Authorization of Federal use of State and local government services and facilities
Hiring temporary personnel
Distributing food, medicine, and supplies
Coordinating with private sector disaster relief organizations
Overseeing mass feeding
Coordinating hazard mitigation
Providing services to save lives, protect property, or promote public health and safety
Use, donation, or lending of Federal equipment, supplies, facilities, or personnel to local personnel
Provide crisis counseling
Approve stockpiling

The President may also declare a National Emergency under the National Emergencies Act, specifying which statutory authorities available for use in an emergency will be exercised.

Emergency Authority When the President and the HHS Secretary Issue a Declaration

When both the President and the HHS Secretary issue declarations, the Secretary may waive certain other regulatory requirements, as follows:

Conditions of participation or certification
Preapproval
State licenses for physicans and other healthcare professionals
Emergency Medical Treatment and Labor Act (EMTALA) sanctions
Stark self-referral sanctions
Performance deadlines and timetables
Restrictions on Medicare and Choice enrollees

The Secretary may waive Health Insurance Portability and Accountability Act (HIPAA) sanctions and penalties relating to the following:

Obtaining a patient’s consent to speak with family members or friends
Honoring a patient’s request to opt out of the facility directory
Distributing a note of privacy practices
Honoring the patient’s right to request privacy restrictions or confidential communications

The National Response Plan (NRP) provides the framework for Federal interaction with State, Tribal, and local governments; the private sector; and nongovernmental organizations (NGOs) for prevention, preparedness, response, and recovery activities.

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Brief Overview of Legal Authorities and Related Guidance

Robert T. Stafford Disaster Relief and Emergency Assistance Act

At the request of the Governor of an affected State, the President may declare a major disaster or emergency if an event is beyond the combined response capabilities of the State, Tribal, and jurisdictional governments. Among other things, this declaration allows Federal assistance to be mobilized and directed in support of State, Tribal, and jurisdictional response efforts. Under the Stafford Act, the President can also declare an emergency without a Gubernatorial request if primary responsibility for response rests with the Federal Government because the emergency involves a subject area for which the United States exercises exclusive responsibility and authority.

Public Health Service Act

The Secretary of HHS has the independent authority under section 319 of the Public Health Service (PHS) Act, as amended, to declare a public health emergency. Following a section 319 declaration, the Secretary can, among other things, take appropriate actions in response to the emergency, such as conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder. The Secretary can also waive certain Medicare and Medicaid requirements to ensure sufficient health care items and resources are available to individuals enrolled in Social Security Act programs. The Secretary may use his/her discretion in determining whether an event is of sufficient severity or magnitude to warrant such a declaration. The Secretary has other authorities under the PHS Act that can be exercised independent of a declaration. The Secretary can make and enforce regulations to prevent the introduction, transmission, or spread of communicable diseases into the U.S., or from one State or possession to another; deploy personnel from the U.S. Public Health Service (USPHS) Commissioned Corps in support of public health and medical operations; provide public health and medical services; and provide for the licensure of biological products.

Homeland Security Presidential Directive (HSPD)

Homeland Security Presidential Directives are issued by the President on matters pertaining to Homeland Security.

As required by Homeland Security Presidential Directive (HSPD)-5, the National Response Plan (NRP) establishes the structure and process for systematic, coordinated, and effective delivery of Federal assistance to augment State, Tribal, and jurisdictional response capabilities. It describes Federal resources that are available to mitigate, prepare for, respond to, and recover from major emergencies and disasters. In addition, the NRP outlines the mechanisms for mobilizing and integrating Federal support. While the NRP is always in effect, its implementation is scalable and flexible to meet the unique operational and information sharing requirements of any major threat, disaster, or emergency, including acts of terrorism.

The types of direct Federal assistance that States, Tribal Nations, and jurisdictions may need, as well as the operations support required to sustain Federal response (e.g., transportation, communications), are organized in the NRP under Emergency Support Function annexes. Each ESF is coordinated by a Primary Agency designated on the basis of its authorities, resources, and capabilities in a particular functional area. Federal public health and medical assistance is provided under ESF #8, and HHS serves as the Primary Agency to coordinate ESF #8 resources to fulfill the requirements identified by the affected State(s), Tribe(s), and jurisdictional authorities. HHS may also support other ESFs, most notably ESF #6— Mass Care, Housing, and Human Services.

The NRP was originally published in December 2004; it was updated in May 2006 based on organizational changes in DHS and lessons learned from Hurricanes Katrina, Rita, and Wilma. At the time of this writing, the NRP is undergoing further revision. Readers are encouraged to visit th DHS Web site (http://www.hhs.gov) periodically for the latest updates to the NRP.

Temporary Waiver or Modification of Normal Federal Program Requirements

Federal Government may temporarily waive or modify certain normal requirements of Federal programs during a national emergency or disaster that is also a public health emergency to facilitate the delivery of public health and medical assistance. For example, Section 1135 of the Social Security Act authorizes the Secretary of HHS to temporarily waive or modify normal operating requirements of Medicare, Medicaid, or the State Children’s Health Insurance Program (SCHIP) during a national emergency or disaster declared by the President that is also a public health emergency declared by the HHS. This action ensures that affected healthcare providers who are unable to comply with certain Federal requirements because of a national emergency or disaster that is also a public health emergency, but who operate in good faith, are given sufficient flexibilities to continue providing services to beneficiaries and receive reimbursement for those services.

Waiver of Healthcare Requirements during Hurricane Katrina

One way the Federal Government facilitates the delivery of medical care and public health services during a major emergency or disaster is by temporarily waiving or modifying normal operating requirements of Federal programs. For example, during the response to Hurricane Katrina, the Secretary of HHS, pursuant to Section 1135 of the Social Security Act, waived the following requirements:*

Certain conditions of participation, certification requirements, program participation or similar requirements, or pre-approval requirements for individual healthcare providers or types of healthcare providers, including, as applicable, a hospital or other provider of services, a physician or other healthcare practitioner or professional, a healthcare facility, or a supplier of healthcare items or services
The requirement that physicians and other healthcare 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)
Sanctions under Section 1867 of the Act (the Emergency Medical Treatment and Labor Act, or EMTALA) for the redirection of an individual to another location to receive a medical screening examination pursuant to a state emergency preparedness plan or transfer of an individual who has not been stabilized if the redirection or transfer arises out of hurricane-related emergency circumstances
Limitations on payments under Section 1851(i) of the Act to permit Medicare Advantage enrollees to use out-of-network providers in an emergency situation
Sanctions and penalties arising from noncompliance with the following provisions of the HIPAA privacy regulations:
The requirements to obtain a patient’s agreement to speak with family members or friends or to honor a patient’s request to opt out of the facility directory
The requirement to distribute a notice of privacy practices
The patient’s right to request privacy restrictions or confidential communications.

The 1135 waiver typically ends with the termination of the emergency period, or 60 days from the date the waiver is first published unless the Secretary of HHS extends the waiver by notice for additional periods of up to 60 days. During Katrina, waivers for EMTALA and HIPAA requirements were in effect for a period not to exceed 72 hours from implementation of a hospital disaster protocol.The 1135 waiver applies only to Federal requirements and does not automatically apply to State requirements for licensure or conditions of participation.

*Department of Health and Human Services, Waiver Under Section 1135 of the Social Security Act, September4, 2005. Available at: http://www.hhs.gov/katrina/ssawaiver.html.

Federal Public Health and Medical Services Response

Federal Public Health and Medical Services Response