Public Health Emergency - Leading a Nation Prepared
Disclaimer: This webpage is intended to provide general information about the HHS Secretary’s legal authorities to prepare for and respond to public health and medical emergencies and is not intended to provide specific legal advice or guidance. This information does not provide an exhaustive list of the HHS Secretary’s legal authorities to prepare for and respond to public health and medical emergencies. Individuals should always seek the advice of an attorney with any questions they may have regarding a legal matter.
The HHS Secretary has
legal authority to take action to prepare for and respond to public health and medical emergencies under several statutes, primarily including the Public Health Service (PHS) Act; Federal Food, Drug and Cosmetic Act; and the Social Security Act. Various other legal authorities may also authorize the HHS Secretary to respond to public health and medical emergencies.
In general, the legal authority of the HHS Secretary for each of the following circumstances is:
Even without the HHS Secretary declaring a public health emergency under section 319 of the PHS Act, he/she has broad legal authorities to provide assistance to states and local entities and to conduct studies. Some examples of actions that the HHS Secretary may take, if appropriate, include:
The HHS Secretary is authorized to take the following actions when a Public Health Emergency is declared.
A public health emergency declaration may also be the basis for the Department of Labor to award dislocated worker program grants for disaster relief.
A declaration of a public health emergency terminates after 90 days or when the Secretary declares that the emergency no longer exists, unless renewed by the Secretary.
In addition to his regular authorities, the HHS Secretary may be authorized or directed to take other actions when the President declares a major disaster or an emergency under the Robert T. Stafford Act or an emergency under the National Emergencies Act.
The President may declare a major disaster under the Stafford Act when a natural catastrophe (i.e., hurricane, tornado, earthquake, etc.) or, regardless of cause, any fire, flood, or explosion causes damage that in the determination of the President is of sufficient severity and magnitude to warrant major disaster assistance 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. The Stafford Act also authorizes the President to declare an emergency when, 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.
The Stafford Act authorizes a multitude of Federal agency actions in response to a major disaster or emergency, such as the following:
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.
When the President declares a major disaster or an emergency and the HHS Secretary declares a public health emergency, the Secretary is authorized to take certain actions in addition to his regular authorities. For example, under section 1135 of the Social Security Act, he may temporarily waive certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in Social Security Act programs in the emergency area and time periods. Examples of these 1135 waivers or modifications include:
In addition, the Secretary may waive Health Insurance Portability and Accountability Act (HIPAA) Privacy rule sanctions and penalties relating to the following:
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 waivers under section 1135 of the Social Security Act typically end with the termination of the emergency period, or 60 days from the date the waiver or modification is first published unless the Secretary of HHS extends the waiver by notice for additional periods of up to 60 days. Waivers for EMTALA (for emergencies that do not involve a pandemic disease) and HIPAA requirements are limited to a 72-hour period beginning upon implementation of a hospital disaster protocol. Waiver of EMTALA requirements for emergencies that involve a pandemic disease last until the termination of the pandemic related emergency. The waiver for licensure applies only to federal requirements and does not automatically apply to state requirements for licensure or conditions of participation.
* The HHS Secretary has other authorities that may permit him to take similar actions even in absence of a public health emergency declaration.
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