The year 2019 has brought many changes in both public and private sector, with current initiatives and bills being under review to become public law or amend current legislation. It is, with no surprise, that new laws or amendments to current legislation are made by targeting imperatives critical to our times and in favor of the overall American population. In fact, one of these imperatives has been the topic of Public Health Service and Emergency Preparedness and Response. At the United States, the Assistant Secretary for Preparedness and Response (ASPR) has the mission to save lives and protect Americans from 21st century health security threats. As one of the agencies under the Department of Health and Human Services (HHS), ASPR leads the nation in preventing, preparing for, and responding to the adverse health effects of public health emergencies and disasters. Specifically, ASPR focuses on preparedness planning and response, conducts countermeasures research, manages development of initiatives and procurement related to emergency preparedness and response, builds federal emergency medical operational capabilities, and coordinate and provide grants to strengthen the capabilities of hospitals and health care systems in public health emergencies and medical disasters. It is with joy that ASPR announces the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA) officially becoming public law on June 24th, 2019.

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PAHPAIA became public law with the purpose of strengthening healthcare and public care readiness, increasing transparency, and reinforcing response and recovery programs. PAHPAIA reauthorizes certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response. It also clarifies language in some legislation found in the Code of Federal Regulations (CFR) in relation to Public Health and updates time frames for these regulations to be effective.

Some of the highlights of the PAHPAIA act reads as following:

  • No later than 2 years after the date of enactment of the PAHPAIA act and every 2 years thereafter, the Secretary shall conduct an evaluation of the evidence-based benchmarks and objective standards. Such evaluation shall be submitted to the congressional committees of jurisdiction together with the National Health Security Strategy, at such time as such strategy is submitted. Specific requirements of this evaluation can be found at the act itself (Title II – Subsection 2).
  • PAHPAIA authorized a funding increase for the Hospital Preparedness Program from $374.4 million to $385 million, which would continue to pass trough state and territory health departments to healthcare coalitions. Congress must appropriate specific funding levels as part of the annual appropriations process, including any increase.
  • No later than 2 years after the date of enactment of the PAHPAIA act and on annual basis thereafter, in accordance with the strategy and implementation plan submitted no later than 18 months after the date of enactment of the PAHPAPIA act, the Secretary shall, taking into account recommendations provided by the National Biodefense Science Board, develop a budget plan based on the strategy and implementation plan submitted.
  • ASPR, along with the Department of Homeland Security (DHS) and the Director of National Intelligence, will coordinate regularly on threat assessments, including emergency health security threats, so that ASPR will guide its decision-making process based on these assessments to formulate medical countermeasures.
  • PAHPAIA reauthorizes the states and territories to have the ability to reassign federally funded personnel temporarily in public health emergencies to support response. A public health emergency must be declared by the HHS Secretary before the states request state personnel whose salaries are funded by HHS in whole or in part.
  • PAHPAIA provides the National Disaster Medical System (NDMS) direct hire authority which streamlines the federal hiring process for NDMS.
  • Coalitions funded under the Hospital Preparedness Program (HPP) can now use funding for response activities and work with other healthcare coalitions or state departments on greater accountability, thus, fostering coordination with states and other entities and reducing duplication of effort.
  • PAHPAIA authorizes ASPR to establish guidelines for the Regional Disaster Health Response System (RDHRS) and use HPP funding to support demonstration projects related to development implementation of these guidelines. The Government Accountability Office (GAO) will assess the program within three years to report findings, challenges, and limitations to Congress.
  • The Secretary may provide technical assistant to states, localities, tribes, and territories regarding interoperability and technical standards set forth by the Secretary.
  • Project BioShield has been authorized funding levels with appropriations authorized for 10 years rather than yearly, in order to promote pharmaceutical and biotechnology companies to work with the Biomedical Advanced Research and Development Authority (BARDA) on manufacturing, development, and acquisition of medical countermeasures.
  • Programs that develop medical countermeasures for pandemic influenza and other emerging infectious diseases are authorized to received annual funding from Congress rather than having funding from supplemental appropriations after public health emergencies happened, in order to have a proactive approach to infectious diseases, such as conducting research and develop the appropriate countermeasure.

To conclude, PAHPAIA will allow increased funding towards programs that deal with emergency preparedness and response. PAHPAIA increases the evaluation areas for current and new public health and healthcare related programs as well as specify reporting requirements on data, findings, and outcomes. PAHPAIA also foster collaboration with states and localities for both support and coordination of programs and resources to effectively enhance preparedness and response to emergencies. Moreover, PAHPAIA allows for increased funding on programs that develop countermeasures to current and new medical threats and supports a proactive approach to prepare for such threats.

 

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Roberto Calderon is an associate consultant at The Center for Organizational Excellence, Inc., a management consulting firm based out of Rockville, MD specializing in organizational effectiveness, human capital, data management and information technology solutions. He has authored numerous insights on topics such as data standards and technology audits.

Government HHS Innovation laws PAHPAIA public health public law regulation