This bill — the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 — would reauthorize programs under the Pandemic and All-Hazards Preparedness Act (PAHPA) and amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. There are seven titles to this bill, each of which is summarized below.
Title I: Strengthening and Improving the National Health Security Strategy
This part of the bill would:
- Clarify that the purpose of the National Health Security Strategy is to describe potential public health threats facing our nation and identify processes to prepare responses to such threats.
- Incorporate three new items into the Strategy: 1) a description of the current public health workforce and its capabilities to improve medical surge capacity; 2) considerations for zoonotic disease and disease outbreaks related to food and agriculture; and 3) global health security and environmental hazards as they relate to domestic public health preparedness and response capabilities.
Title II: Improving Preparedness and Response
This part of the bill has 10 sections, each of which is summarized below:
- Section 201: Improving Benchmarks and Standards for Preparedness and Response — This section would require the evaluation of existing performance measures, benchmarks, and standards for two core preparedness and response programs, the Public Health Emergency Preparedness (PHEP) cooperative agreement and the Hospital Preparedness Program (HPP).
- Section 202: Amendments to Preparedness and Response Programs — Would clarify that the PHEP cooperative agreement should be administered through the Centers for Disease Control and Prevention (CDC) and update requirements for the plans required of all PHEP eligible entities. It’d also 1) provide additional flexibility for PHEP and HPP awardees to come into compliance with program benchmarks and standards in the event of failure to meet those standards; 2) require PHEP grantees to include a description of efforts to incorporate health care facilities and critical infrastructure partners such as utility companies into preparations for public health emergencies in their funding applications; and 3) reauthorize HPP through 2023.
- Section 203: Regional Public Health Emergency Preparedness and Response Systems — This would charge the Assistant Secretary for Preparedness and Response (ASPR) with developing guidelines to inform regional hospital, health care facility, and public health facility systems of varying levels of capabilities to treat patients affected by chemical, biological, radiological, or nuclear (CBRN) threats, including emerging infectious diseases, and improving medical surge capabilities and capacity. It’d also use lessons learned from the 2014 Ebola virus outbreak to develop guidelines for regional systems to help provide a roadmap for regions agree the country to leverage their resources in the event of a bioterror attack, an emerging infectious disease outbreak, or a pandemic. Additionally, it’d allow the ASPR to develop and implement and demonstration project to put the new guidelines into practice in regions across the country, with the program sunsetting in 2023. It’d also incorporate a coordinated and flexible approach to regional health care emergency preparedness and response into the National Health Security Strategy; encourage PHEP grantees to coordinate with regional health care emergency response capabilities; prioritize awarding HPP grants to entities that’ll enhance coordination among one or more facilities in a regional health care emergency system; and allow additional resources authorized under HPP to go toward the new regionalized systems, so as not to take existing resources away from HPP.
- Section 204: Military and Civilian Partnership for Trauma Readiness — This section of the bill authorizes the HHS Secretary, acting through the ASPR and in consultation with the Secretary of Defense, to award grants to no more than 20 trauma centers to enable military trauma teams to provide trauma care at those centers. It’d integrate military trauma providers at these centers’ trainings and drills for public health emergencies, and require that these military trauma providers be allowed to deploy for military operations or training and to respond to public health emergencies or mass casualty incidents as needed. This section of the bill would be funded through 2023 with no more than $1 million per year per trauma center.
- Section 205: Public Health Situational Awareness and Biosurveillance Capabilities — This section of the bill would direct the GAO to conduct a study on federal spending for CDC facilities and improved capabilities for responding to bioterrorism and other public health emergencies. It would also update and improve the CDC’s biosurveillance capabilities to advance public health situational awareness by: updating the use of technical and reporting standards, including interoperability standards for data elements submitted to the biosurveillance network; improving coordination and collaboration with HHS and across federal agencies to exchange data in the biosurveillance network to better inform the situational awareness needed to monitory, identify and respond to CBRN threats; convening a public meeting for public and private stakeholders to improve the biosurveillance network’s development and function; updating the biosurveillance network’s strategy and implementation plan based on expert input; establishing an annual budget plan to ensure the biosurveillance network’s efficient and effective utilization; and improving coordination with the intelligence community to ensure that the biosurveillance network’s design and capabilities align with the threats facing the U.S.It’d also authorize the HHS Secretary to appoint up to 30 specialists at the CDC with expertise in capabilities related to biosurveillance, such as experts in informatics and data analytics, to work on the biosurveillance network. The GAO would be required to evaluate and report on activities related to the development and implement of the biosurveillance network and provide subsequent recommendations. This section of the bill would also reauthorize biosurveillance and situational awareness programs through 2023.
- Section 206: Strengthening and Supporting the Public Health Emergency Fund — This section of the bill would improve the existing Public Health Emergency Fund (PHEF) by identifying key authorities PHEF dollars can be used by in the immediate aftermath of, or lead up to, a public health emergency. It would also require the PHEF’s review by the Secretary and GAO, who’d be responsible for making recommendations to improve the program.
- Section 207: Improving All-Hazards Preparedness and Response by Public Health Emergency Volunteers — This part of the bill would encourage states to develop and implement programs and policies allowing the licensure of medical professionals to enable them to cross state lines during a public health emergency. It would also clarify that the National Disaster Medical System, Medical Reserve Corps members, and individual practitioners are eligible to enroll in the Emergency System for Advanced Registration of Volunteer Health Professionals (ESAR-VHP). It’d advise the Secretary to publicize the ways in which states are waiving licensing requirements for health professional volunteers during a public health emergency in order to encourage state and individual participation in ESAR-VHP. FInally, it’d reauthorize ESAR-VHP through 2023.
- Section 208: Clarifying State Liability Law for Volunteer Health Care Professionals — This section of the bill would clarify the application of state liability laws for health care professionals who are members of the Medical Reserve Corps or included in the Emergency System for Advance Registration of Volunteer Health Professionals. For such an individual providing health care services in a state with a public health emergency, a major declared disaster or a national emergency, under certain conditions, applies the liability laws of the state for which the emergency has been determined and in which the service is being provided.
- Section 209: Report on Adequate National Blood Supply — This section of the bill would require a report with recommendations to address challenges with the national blood supply, including: donor recruitment challenges, maintaining the adequacy of the blood supply during a public health emergency and efforts to promote innovative technologies to improve the blood supply.
- Section 210: Report on the Emergency Preparedness and Response Capabilities and Capacities of Hospitals, Long-term Care Facilities, and Other Health Care Facilities — This section of the bill would require a report on the public health preparedness and response capabilities of health care facilities. This would include a review of the effectiveness benchmarks and standards for preparedness programs, an identification of gaps in such benchmarks and standards and an evaluation of coordination-critical infrastructure entities and environmental health agencies.
Title III: Reaching All Communities
This part of the bill has six sections, which are summarized below:
- Section 301: Strengthening and Assessing the Emergency Response Workforce — This part of the bill recognizes that public health emergencies have strained the public health emergency workforce and highlighted gaps in workforce preparedness. To address these challenges, this section: 1) includes greater flexibility in pre-positioning response teams in advance of a public health emergency or potential public health emergency; 2) requires a joint review of the National Disaster Medical System (NDMS) and an assessment of America’s medical surge capacity; 3) improves communication with Congress by requiring the Secretary to notify Congress when the NDMS workforce is insufficient to address a public health emergency; 4) bolsters hiring authorities to allow faster onboarding of NDMS to decrease the shortage in the health care emergency response workforce; 5) extends death benefits for NDMS participants that are allotted to other public safety officers, including FEMA volunteers, through 2021; 6) strengthens the recruitment of highly-qualified providers to the Epidemic Intelligence Service (EIS) by extending loan repayment options for EIS program participants; and 5) requires a GAO report on the volunteer health care workforce’s capacities, capabilities and gaps as well as recommendations for addressing the gaps. It would also reauthorize the NDMS and Medical Reserve Corps programs through 2023.
- Section 302: Health System Infrastructure to Improve Preparedness and Response — This section encourages the ASPR to coordinate with public and private-sector partners that provide critical supplies or information to an affected area during a public health emergency, in order to assist with the response. It would also require the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to incorporate the need for certain medical supplies to be used with medical countermeasures (MCM) in MCM enterprise planning. It’d also direct the Secretary to take manufacturing capacity and outside sources of medical supplies into account when replenishing products in the Strategic National Stockpile (SNS). Finally, it’d authorize the ASPR to conduct a study on issues with the potential the adversely affect the handling and rapid delivery of medical countermeasures.
- Section 303: Considerations for Al-Risk Individuals — This would update and align the term “at-risk individual” across the PAHPA framework to improve and ensure consistency in considerations and provide clarity throughout the framework. It’d also encourage the director of at-risk individuals to incorporate appropriate data and information relevant to detecting emerging public health threats that may affect at-risk individuals into the CDC’s existing situational awareness and biosurveillance network.
- Section 304: Improving Emergency Preparedness and Response Considerations for Children — This section would codify and continue the work of the CDC’s Children’s Preparedness Unit to ensure that children’s needs are taken into consideration when preparing for and responding to public health emergencies.
- Section 305: National Advisory Committees on Disasters — This section would reauthorize three national advisory committees on vulnerable groups in disasters (the National Advisory Committee on Children and Disasters, National Advisory Committee on Seniors and Disasters, and National Advisory Committee on Individuals with Disabilities in Disasters) through 2023. It’d also require these advisory committees to coordinate their duties and activities to address their respective populations’ overlapping needs and reduce duplication of efforts across committees.
- Section 306: Guidance for Participation in Exercises and Drills — This section would require the DHS Secretary to issue final guidance on the participation of federally funded public health personnel in drills and operational exercises for public health emergency preparedness and response.
Title IV: Prioritizing a Threat-Based Approach
This title of the bill has five sections, which are summarized below:
- Section 401: Assistant Secretary for Preparedness and Response — This section would clarify the Congressional intent for the ASPR to utilize biodefense and emergency preparedness and response experience. It’d also encourage the ASPR to coordinate with the intelligence community and defense and public health agencies in their work to develop and strengthen America’s emergency preparedness and response framework.
- Section 402: Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) — This section would codify the PHEMCE, an entity comprised of heads of relevant federal agencies, to inform the research, development, and procurement of MCMs for the SNS.
- Section 403: Strategic National Stockpile — This section would provide additional direction and a threat-based focus for the existing annual review of the SNS. It’d also require additional information on SNS procurement and replenishment decisions, along with advanced planning for deployment, distribution, and dispensing for additions to the SNS. It would also charge the GAO with reviewing processes and decisions related to the SNS. FInally, it’d reauthorize the SNS through 2023.
- Section 404: Preparing for Pandemic Influenza, Antimicrobial Resistance, and Other Significant Threats — This section would authorize the Director of the Biomedical Advanced Research and Development Authority (BARDA) to development strategic initiatives for threats posing a significant national security risk. These strategic initiatives would accelerate and support advanced R&D and procurement of countermeasures to address: 1) threats for which no countermeasure exists, or for which existing countermeasures may become ineffective; 2) threats that consistently exist or are continually circulating in a human or animal population and have significant potential to become a pandemic; and 3) certain threats related to CBRN agent exposure, which may present increased complications in treating a countermeasure resistant disease or condition during a public health emergency. It’d also authorize the ASPR to implement strategic initiatives or activities to address threats, including pandemic influenza or a CBRN agent, posing a significant risk to public health and national security based on such threats’ characteristics. This authority would be authorized through 2023.
- Section 405: Reporting on the Federal Select Agent Program — This section would require the Secretary to report on the implementation of recommendations from the Federal Experts Security Advisory Panel and the Fast Track Action Committee regarding improvements to the Select Agent Program.
Title V: Increasing Communication in MCM Research and Development
This title of the bill has five sections, which are summarized below:
- Section 501: Medical Countermeasure Budget Plan — This section would update the Countermeasure Budget Plan to include considerations for manufacturing capabilities and capacity for MCMs, information on new and innovative technologies that may support MCM R&D, and improve the communication on areas of priority for MCM development.
- Section 502: Material Threat and Medical Countermeasure Notifications — This section would require the HHS and DHS Secretaries to notify the relevant Senate and House committees of the material threat list on an annual basis, and to promptly notify Congress each time there’s a change to the threats on the list. It’d also require the Secretary to notify a MCM manufacturer as soon as possible regarding their decision to replenish such MCM in the SNS at the end of its contract.
- Section 503: Availability of Regulatory Management Plans — This section would require the FDA to post the processes and information necessary for potential MCM sponsors to apply for a regulatory management plan on the internet, in order to raise awareness of the use of the plans for MCMs.
- Section 504: BARDA and the Special Reserve Fund — This section would reauthorize BARDA and the BioShield Special Reserve Fund through 2023.
- Section 505: Additional Strategies for Combating Antibiotic Resistance — This section would codify the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria to advise the HHS Secretary on efforts to reduce or combat antibiotic-resistant bacteria that may present a public health threat and provide input to improve capabilities to prevent, diagnose, mitigate, or treat such resistance.
Title VI: Advancing Technologies for Medical Countermeasures
This title has seven subsections, which are summarized below:
- Section 601: Administration of Countermeasures — This section would clarify BARDA’s ability to use existing resources for developing technologies to assist in the administration of countermeasures.
- Section 602: Updating Definitions of Other Transactions — This section would clarify the BARDA Director’s authority to utilize other transactions authorities to further the advanced research and development of medical countermeasures.
- Section 603: Medical Countermeasure Master Files — This would establish a clear process for submitting information and data on technologies into a Master File that may be incorporated into a future application to support a MCM product. It would also require the FDA to notify the Master File holder when the agency has referenced the technology in the Master File. Finally, within three years of this bill’s passage, it’d require the FDA to publish draft guidance on the reliance and use of data and information in the Master Files to support and accelerate the development of countermeasures.
- Section 604: Animal Rule Report — This would require the GAO to consult federal agencies, manufacturers, and other biodefense stakeholders to compile a report on the use of the animal rule in the development of MCMs. This report would be due within three years of this bill’s passage, and if applicable, it’d make recommendations to support and speed MCMs’ research and development.
- Section 605: Review of the Benefits of Genomic Engineering Technologies and Their Potential Role in National Security — This section of the bill would require the HHS Secretary to convene a meeting with federal partners and private entities to discuss the potential role advancements in genomic engineering technologies, including genome editing technologies, may have to play in advancing national health security. It’d also require the ASPR to issue a report after the meeting detailing the discussion and providing recommendations to utilize innovation in genomic engineering technologies to advance national health security.
- Section 606: Report on the Development of Vaccines to Prevent Future Epidemics — This section of the bill would require a report on previous efforts to coordinate with other countries during public health emergencies to conduct advanced research and development of qualified pandemic or epidemic products, including the development of products through public-private partnerships.
- Section 607: Strengthening Mosquito Abatement for Safety and Health (SMASH) — This section of the bill would reauthorize public health tools supporting states and localities in their mosquito surveillance and control efforts, especially those linked to vector-borne disease such as the Zika virus. It’d also renew epidemiology-laboratory capacity grants administered by CDC supporting surveillance and response capabilities for infectious diseases at the local level.
Title VII: Reauthorizations and Technical Changes
- Section 701: Reauthorizations and Extensions — This section of the bill reauthorizes funding for: VA medical facilities and influenza vaccine tracking and distribution during an influenza pandemic. It also reauthorizes the temporary reassignment authority and the MCM innovation partner through 2023. It also extends the limited antitrust exemption. Finally, it clarifies the limitations on the disclosure of certain scientific or technical information developed during medical countermeasure research.
- Section 702: Location of Materials in the Stockpile — This section of the bill updates and clarifies limitations on the disclosure of certain information pertaining to the SNS which has the potential to affect national security.
- Section 703: Cybersecurity — This section of the bill requires the development of a national strategy for public health preparedness and response to address cyber-attacks that present a threat to national security. It also clarifies the ASPR’s role as it relates to cyber incidents that present a threat to national health security.
- Section 704: Report — This section of the bill requires a report on the status of the ASPR’s work to reunite unaccompanied minors with their families.
- Section 705 — This section makes technical amendments to the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.