Public Health

The Secretary of the Department of Health and Human Services (HHS) may, under section 319 of the Public Health Service (PHS) Act, determine that: a) a disease or disorder presents a public health emergency (PHE); or b) that a public health emergency, including significant outbreaks of infectious disease or bioterrorist attacks, otherwise exists.

Duration and Notification: The declaration lasts for the duration of the emergency or 90 days, but may be extended by the Secretary. Congress must be notified of the declaration within 48 hours, and relevant agencies, including the Department of Homeland Security, Department of Justice, and Federal Bureau of Investigation, must be kept informed.

Prior to issuing the declaration, the Secretary should consult with public health officials as necessary.

Following a section 319 declaration, the Secretary can:

• Take appropriate actions in response to the emergency consistent with other authorities, including: making grants; entering into contracts; and conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder. Upon request of the recipient of any such award and subject to corresponding reductions in payments, the Secretary may also provide supplies, equipment, and services, and detail employees of the Department to the recipient to aid the recipient in carrying out the award.
• Access “no-year” funds appropriated to the Public Health Emergency Fund to rapidly respond to immediate needs resulting from the PHE, or to rapidly respond to a potential PHE when the Secretary determines that there is a significant potential for a PHE.  The Fund may be used to facilitate coordination among federal, state, local tribal, and territorial entities and public and private health care entities affected by the PHE; to make grants, provide for awards, enter into contracts and conduct investigations including further supporting the Public Health Emergency Preparedness, Hospital Preparedness and Regional Health Care Emergency Preparedness awards; facilitate and accelerate advanced research and development of medical countermeasures; strengthen biosurveillance and laboratory capacity; support initial emergency operations related to preparation and deployment of National Disaster Medical System teams; and carry out other activities determined applicable and appropriate by the Secretary.  The Secretary must report to Congress 90 days after the end of the fiscal year about any funds spent from the Public Health Emergency Fund, the emergency for which funds were spent, and activities undertaken with respect to the emergency. Public Health Emergency Funds supplement, but do not supplant, other Federal, State, and local funds provided for public health grants, awards, contracts, and investigations.
• Enable the Centers for Disease Prevention and Control Director to access the Infectious Diseases Rapid Response Reserve Fund (when funds are so appropriated) to prevent, prepare for, or respond to an infectious disease emergency, either when the Secretary has declared a public health emergency or when the Secretary determines that the emergency has significant potential to imminently occur and potential on occurrence, to affect national security or the health and security of US citizens, domestically, or internationally. 
• Grant extensions or waive sanctions relating to submission of data or reports required under laws administered by the Secretary, when the Secretary determines that, wholly or partially as a result of a public health emergency, individuals or public or private entities are unable to comply with deadlines for such data or reports. The Secretary must notify Congress and publish a Federal Register notice before or promptly after granting an extension or waiver.
• Waive or modify certain Medicare, Medicaid, Children’s Health Insurance Program (CHIP), and Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule requirements. Under section 1135 of the Social Security Act (SSA), the Secretary may waive or modify certain requirements as necessary to ensure to the maximum extent feasible that, in an emergency area during an emergency period, sufficient health care items and services are available to meet the needs of individuals Medicare, Medicaid, and CHIP, and that providers of such services in good faith who are unable to comply with certain statutory requirements are nonetheless reimbursed and exempted from sanctions for noncompliance, absent fraud, or abuse. There must also be a Presidential declaration of an emergency or disaster in order to exercise this authority.
• Adjust Medicare reimbursement for certain Part B drugs. Most Medicare Part B drugs are paid on the basis of the manufacturer’s average sales price (ASP), which manufacturers are required to report quarterly. The ASP-based payment allowance is updated prospectively each quarter, using the data manufacturers report. The statutory scheme results in a two-quarter lag between the date of the reported sale and the date that sale’s price is factored into the Medicare reimbursement rate. In the case of a public health emergency in which there is a documented inability to access drugs and biologicals and a concomitant increase in the price of a drug or biological that is not reflected in the manufacturer’s 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. As of April 2013, CMS has not formally interpreted, nor exercised, this authority. However, in the event of a public health emergency in which this authority were triggered, the price change could be implemented without rulemaking. (See Section 1847A(c)(5)(C) of the Social Security Act, which states that notwithstanding any other provision of law, the Secretary may implement any of the provisions of Section 1847A by program instruction or otherwise.)
• Make temporary (up to one year or the duration of the emergency) appointments of personnel to positions that directly respond to the public health emergency when the urgency of filling positions prohibits examining applicants through the competitive process.
• Use funds from the fiscal year 2019 appropriation to HHS that are available for salaries and expenses of HHS employees to pay travel and related expenses of an employee or family member when the employee is assigned to duty in the U.S. or in a U.S. territory during a period and in a location that are the subject of a public health emergency declaration, and travel is necessary to obtain medical care for an illness, injury, or medical condition that cannot be adequately addressed in that location at that time.
• Enable the Secretary of Defense, in consultation with the Secretary, to deploy military trauma care providers providing care at high-acuity trauma centers pursuant to grants awarded under section 1291 of the PHS Act.
• Waive certain Ryan White HIV/AIDS program requirements (section 2683 of the PHS Act). Under this authority, up to five percent of the funds available under each of the Parts A and B supplemental pools may be shifted to ensure access to care during a public health emergency declared by the Secretary under section 319 of the PHS Act or an emergency or disaster declared by the President under the Stafford Act or the National Emergencies Act in the geographic area where the emergency, major disaster, or public health emergency exists. In addition, the Secretary may waive such requirements of title XXVI of the PHS Act to improve the health and safety of those receiving care under this title and the general public. This waiver authority is limited to the time period for which the emergency, major disaster, or public health emergency declaration exists.
• Modify practice of telemedicine. The Ryan Haight Online Pharmacy Consumer Protection Act and implementing regulations allow the Secretary, with concurrence of the DEA Administrator, to designate patients, patient locations, and use of controlled substances during a public health emergency declared by the Secretary.
• On a State by State basis, as the circumstances of the emergency reasonably require and for the period of the emergency, grant an extension or waive application deadlines or compliance with any other requirement of certain SAMHSA grants. Such grants include those authorized under sections 521, 1911, or 1921 of the PHS Act. This authority also applies to allotments authorized under Public Law 99-319.
• Allow State and local governments to access the General Services Administration (GSA) Federal supply schedule when using federal grant funds. GSA policy allows state, local, and tribal government grantees to use federal supply schedules to respond to public health emergencies declared by the Secretary. Pursuant to 48 U.S.C. § 1469e as amended, Puerto Rico, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and the U.S. Virgin Islands may always buy off of the GSA schedules regardless of whether there is a declared PHE.
• Temporarily reassign state and local personnel. The Secretary may authorize a requesting Governor of a state or tribal organization to temporarily reassign state and local public health department or agency personnel funded in whole or in part through programs authorized under the PHS Act to immediately address a public health emergency in the state or Indian tribe during the period of the emergency. 
• Limit liability of health care professionals who are members of the Medical Reserve Corps or professionals included in the Emergency System for Advance Registration of Volunteer Health Professionals responding to a PHE in the initial 90 days so that such professionals shall be subject only to the State liability laws in which the professional has been deployed to the PHE and only to the extent permitted under the laws of the State in which care is provided.  
• Determine a waiver of Paperwork Reduction Act (PRA) requirements is necessary. Section 319(f), recently added by the 21st Century Cures Act, allows the Secretary to determine that the circumstances of a PHE or a disease or disorder, including a novel and emerging public health threat that is significantly likely to become a PHE, necessitate a waiver from PRA requirements. If the Secretary makes such a determination, then PRA requirements for voluntary collection of information do not apply during the immediate investigation of and response to the PHE during the period of the PHE or the time period necessary to determine if a disease or disorder, including a novel and emerging public health threat, will become a PHE.
• Waive certain requirements of the Drug Supply Chain Security Act (DSCSA). A public health emergency is considered an “emergency medical reason” under the DSCSA, 21 U.S.C. 360eee. Thus, upon the Secretary’s declaration of a public health emergency, certain activities are automatically excluded through the time period of the declaration. Notably, product distribution for such emergency medical reasons is excluded from the DSCSA definitions of “transaction” and “wholesale distribution.” Therefore, the DSCSA requirements related to product tracing and wholesale distribution do not apply to trading partner activities that address the public health emergency declaration.
• Enable the Department of Labor (DOL) to issue dislocated worker program grants for disaster relief employment pursuant to 29 U.S.C. § 3225. A Federal agency emergency or disaster declaration or a Stafford Act declaration triggers an opportunity for eligible entities to apply for disaster relief employment National Dislocated Worker Grants. In order for a Federal agency declaration to trigger this authority, the chief official of a Federal agency with authority for or jurisdiction over the Federal response must declare or otherwise recognize an emergency or disaster situation of national significance that could result in a potentially large loss of employment.

---

U.S. Public Health Emergency Declarations

Declarations of a Public Health Emergency -- list of current and previous Public Health Emergency declarations and renewals.

U.S. Public Health Emergency Declaration Authorizations

Once a PHE is declared, the following can be authorized.

 

Defense Production Act

By presidential authority, the DPA allows federal agencies to expedite and expand the supply of materials and services from the U.S. industrial base by requiring companies to prioritize government contracts to promote and support national defense, emergency preparedness and response, and critical infrastructure. The DPA affords the President emergency authority to exert control over domestic industries in ways that would be considered "anti-American" under normal conditions.

 

Public Health Emergency Fund

Access "no year" funds from the fund to rapidly respond to immediate needs resulting from the PHE, including facilitating coordination among federal, state, local, public, and private health entities affected by the PHE, facilitating and accelerating advanced research and development of medical countermeasures, strengthening biosurveillance and laboratory capacity, and supporting initial emergency operations related to preparation and deployment of National Disaster Medical System teams.

 

Infectious Diseases Rapid Response Reserve Fund

Allow the CDC to access the fund to prevent, prepare for, or respond to an infectious disease emergency.

 

Medicare/Medicaid/CHIP requirements

Under Section 1135 of the Social Security Act, the HHS Secretary can waive or modify certain requirements as necessary to ensure to the maximum extent feasible that, in an emergency area during an emergency period, sufficient health care items and services are available to meet the needs of individuals Medicare, Medicaid, and CHIP, and that providers of such services in good faith who are unable to comply with certain statutory requirements are nonetheless reimbursed and exempted from sanctions for noncompliance, absent fraud, or abuse.

Waiver or Modification of Requirements Under Section 1135 of the Social Security Act

• List of current and previous waivers or modification of requirements were issued for a variety of public health emergencies including wildfires, hurricanes, tropical storms, flooding, H1N1, and COVID-19. Waivers and modifications to requirements include, but are not limited to: state licensing requirements, conditions of participation, and the furnishing of supplies.

 

Ryan Haight Online Pharmacy Consumer Protection Act

Modifies the practice of telemedicine by overriding some measures in the act to allow for to the HHS Secretary to designate patients, patient locations, and use of controlled substances during a public health emergency.

 

Emergency Use Authorization (EUA)

Under Section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, the FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain criteria are met, including when there are no adequate, approved, and available alternatives.

The 2013 Pandemic and All-Hazards Preparedness Reauthorization Act amended Section 564 of the FD&C to provide more flexibility to the HHS Secretary to authorize the FDA to issue an Emergency Use Authorization. As amended, the Secretary now may determine that there is a public health emergency or significant potential for a public health emergency that affects, or has significant potential to affect, national security or the health and security of U.S. citizens living abroad and involves a biological, chemical, radiological, or nuclear agent or disease or condition that may be attributable to such agent(s).  The Secretary may then declare that the circumstances justify emergency authorization of a product, enabling the FDA to issue an EUA  before the emergency occurs. 

Public Health Emergency Determinations to Support an Emergency Use Authorization

• List of determinations and resulting EUAs that have been issued to date.

 

Disaster Relief and Emergency Assistance Act (Stafford Act)

The 1998 Disaster Relief and Emergency Assistance Act (Stafford Act) allows for federal natural disaster assistance for state and local governments in carrying out their responsibilities to aid citizens. The Act gives FEMA the responsibility for coordinating government-wide relief efforts. The Federal Response Plan includes contributions from 28 federal agencies and non-governmental organizations, such as the American Red Cross.