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. The discussion 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:
Legal Authority without Declaration of a Public Health Emergency
Even without the HHS Secretary declaring a public health emergency under section 319 of the PHS Act, 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:
- Developing and taking necessary steps to implement a plan to assist states and localities to control epidemics and to meet other health emergencies or problems
- Assisting and promoting research and studies into the causes, diagnosis, treatment, control, and prevention of diseases
- Establishing isolation and quarantine
- Maintaining the Strategic National Stockpile (SNS)
- Activating the U.S. Public Health Service (USPHS) Commissioned Corps and the National Disaster Medical System (NDMS), and deploying select members of the Medical Reserve Corps (MRC)
- Maintaining safety of food, drugs, biological products, and medical devices
- Providing temporary assistance to needy families and responding to needs of “at-risk” individuals
- Providing, through a separate declaration, immunity from liability for activities related to supply, distribution and use of medical countermeasures to chemical, biological, radiological, nuclear, and pandemic and epidemic threats.
- Providing, through a separate declaration, that FDA may authorize medical products intended to prevent, diagnose, or treat a disease or condition involving a specified biological, chemical, radiological, or nuclear agent or agents, or intended to prevent, diagnose, or treat a serious or life-threatening disease or condition caused by such a product described for emergency use.
- Waive certain requirements for drugs covered by risk evaluation and mitigation strategies.
- Permit the dispensing of medical products intended to prevent, diagnose, or treat a disease or condition involving a biological, chemical, radiological, or nuclear agent or agents, or intended to prevent, diagnose, or treat a serious or life-threatening disease or condition caused by such a product without a prescription for the duration of an emergency situation.
- Exempting (for 30 days, subject to one 30-day renewal) a person from select agents requirements as necessary to provide for timely participation of the person in a response to a domestic or foreign public health emergency that involves the select agent or toxin.
Legal Authority with Declaration of a Public Health Emergency
The HHS Secretary is authorized to take the following actions when a Public Health Emergency is declared.
- Consistent with regular authorities*:
- 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 (when funds are so appropriated)
- Grant extensions or waive sanctions related to deadlines for submitting data or reports required under laws administered by the Secretary
- 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 to support surge capacity needs in hospitals and aid stations
- Modify practice of telemedicine
- Allow State and local governments to access the General Services Administration Federal supply schedule when using federal grant funds
- Allow temporary reassignment of State and local personnel during a public health emergency
- Adjust Medicare reimbursement for certain Part B Drugs
- Waive certain Ryan White HIV/AIDS program requirements
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.
Legal Authority When the President Declares a Major Disaster or an Emergency
In addition her 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:
- 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
- Use, donation, or lending of Federal equipment, supplies, facilities, or personnel to state and local governments • Provide crisis counseling (only in response to a major disaster)
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 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 her regular authorities. For example, under section 1135 of the Social Security Act, she 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:
- Certain conditions of participation, certification requirements, program participation or similar requirements for individual health care providers or types of health care providers
- Preapproval requirements
- State licenses for physicians and other healthcare professionals (this waiver is for purposes of Medicare, Medicaid, and CHIP reimbursement only – the state determines whether a non-Federal provider is authorized to provide services in the state without state licensure)
- Emergency Medical Treatment and Labor Act (EMTALA) sanctions for direction or reallocation of an individual to another location to receive medical screening pursuant to an appropriate state emergency preparedness plan or a state pandemic preparedness plan for the transfer of an individual who has not been stabilized if the transfer is necessitated by the circumstances of the declared Federal public health emergency. A waiver of EMTALA 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.
- Stark self-referral sanctions
- Performance deadlines and timetables may be adjusted (but not waived).
- Limitations on payment for healthcare items and services to permit Medicare Advantage Plan enrollees to use out of network providers in an emergency situation
In addition, 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 waiver of HIPPA 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 her to take similar actions even in absence of a public health emergency declaration.