Letter on Reauthorization of the Pandemic and All-Hazards Preparedness Act

Governors have firsthand experience on how to improve the ability of states and territories to respond to public health crises, gaps in the PAHPA framework, and ways to bolster partnerships between the federal government, states/territories and localities, the private sector, and NGO stakeholders.

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Dear Chairman Sanders and Ranking Member Cassidy,

As co-chairs of the National Governors Association’s (NGA) Public Health and Disaster Response Task Force, we appreciate the opportunity to provide feedback on the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA). Governors have been at the forefront of combatting the unprecedented COVID-19 pandemic and other public health emergencies. For this reason, we have firsthand experience on how to improve the ability of states and territories to respond to public health crises, gaps in the PAHPA framework, and ways to bolster partnerships between the federal government, states/territories and localities, the private sector, and non-government stakeholders.

During these past three and a half years, Governors issued executive orders, activated the National Guard, were provided with a number of temporary federal flexibilities and Congress appropriated an unprecedented amount of federal funding to assist in responding to the COVID-19 pandemic. As Governors we must continue to effectively deliver state services to protect the health and safety of our residents and to stimulate economic recovery and growth. The pandemic has not only tested our public health systems in ways unimaginable but has also highlighted the many gaps that exist both at the federal, state and local levels. States and territories faced major challenges from securing reliable access to PPE, testing, vaccines, therapeutics, along with gaps in public health data systems and a break-down in communication, while dealing with misinformation out in the public.

We are hopeful that you take into careful consideration the many gaps and challenges states and territories face, along with many of the lessons learned from the COVID-19 pandemic. Please find attached feedback and recommendations from states and territories as the Senate HELP Committee deliberates reauthorization of the PAHPA to improve our nation’s preparedness and response capabilities and capacities along, with our recovery efforts. As Governors, we stand ready to assist you as you develop bipartisan legislation that will help ensure that our states and territories are prepared and ready for future health crises.

Sincerely,

Governor Ned Lamont, Co-Chair, NGA Public Health and Disaster Response Task Force, National Governors Association

Governor Phil Scott, Co-Chair, NGA Public Health and Disaster Response Task Force, National Governors Association

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Program Effectiveness

What specific changes could Congress make to improve the efficiency and effectiveness of current HHS programs and activities?

• Strengthen coordination between CDC, ASPR and other HHS agencies at the federal level for determining preparedness capabilities and requirements including response operations.
• Better identify and delineate the role of FEMA vs HHS (ASPR, CDC) in public health emergencies. When ASPR was elevated to the same level as CDC, it created communication issues, delayed decision-making, and changes during an emergency response to previously planned activities.
  • -As an example, vaccine orders traditionally run through state immunization information systems (IIS) to VTrcks. During the Mpox response, ASPR’s HPOP system was used for vaccine orders. This required additional staff time, manual data entry (IIS and VTrcks are not connected to HPOP), and a lack of essential data in state IIS (i.e., vaccine inventory).
• FDA’s EUAs were critical to supporting pandemic response including testing and therapeutics. Often supporting materials were too dense for some audiences. Need documentation that includes quick sheets and one pagers.
• Strengthen the Strategic National Stockpile Program for increased transparency and distribution capabilities. Effectively engage private sector partners for manufacturing and distribution.
• Mobilization of healthcare providers to support medical surge was a critical component of federal response. DoD MRT teams augmented hospitals within states. Need flexibility to match team types to hospital needs. The National Disaster Medical System is a critical resource to maintain but needs considerations for deployments of more than two weeks.
• Continued funding for emergency preparedness cooperative agreements. These agreements support medical and public health preparedness for all hazards vs disease-specific responses. Disease-specific funds are often too siloed and prevent overall modernization of public health infrastructure to protect the nation’s health security.
• Reauthorize public health and healthcare preparedness programs with robust funding levels to ensure strong capabilities for the nation’s response.
  • -Funding to respond to emergencies needs to be flexible. COVID-19 emergency funds could not be used to respond in a timely manner to emergent Mpox concerns.

• The Public Health Emergency Preparedness program (PHEP), funded by the CDC, and the Hospital Preparedness Program (HPP), funded by ASPR (both agencies under U.S Health and Human Services), have leveraged similar required capabilities towards the preparedness activities within the state. While the capabilities are similar (mass care, medical countermeasure distribution, response coordination), the actions taken by the federal program administrators are creating an unnecessary separation of these activities. CDC and ASPR continue to demand a separation of the activities at the state and local levels to the detriment of the success of the response.
  • -For example, states must get specific approval to purchase disposable medical supplies such as syringes. Those approval processes require that the supplies be tracked by funding source and used only for specific public health or medical response when they can be used for both hospital and public health vaccination programs. Still, we are required to maintain tracking and distribution by utilization and funding source, even though the activities are part of the PAHPRA outputs.
  • -In FY2018-19, one state suffered through 18 Notices of Grant Award amendments that took months to resolve and further demonstrated their lack of cooperation in this partnership program.
• Federal oversight includes requirements that cannot be met reasonably and conflicts with state operations. The program would be more effective with more state-level input and control.
  • -Federal grantors require pre-approval of overtime. However, some emergencies happen after standard hours, and preapproval cannot be obtained.
  • -Excess administrative burden as prior approval is required for office supplies, durable medical equipment, and for providing annual wages of all staff regardless of their time commitment to the program.

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The Strategic National Stockpile (SNS)

State and local health departments are the front lines of defense against infectious disease threats and must be equipped to quickly respond on the ground. Empowering states to hold their own stockpiles, in addition to the federal SNS, will improve their ability to protect their populations. States may have specific needs outside the federal SNS that can be better managed through their own stockpiles.

These may include regional threats such as mosquito-borne diseases (Zika, dengue, and chikungunya) and natural disaster preparedness such that require temporary medical stations tailored to hurricane response or extreme drought. The Strategic National Stockpile program continues to operate without sharing the contents of that stockpile with the states that may be requesting those supplies during an emergency. During COVID-19 states could not use masks (N95 respirators) received from the stockpile due to fit testing requirements.

• Recommend extending the authorization for grants to support state strategic stockpiles beyond FY24 as part of PAHPA reauthorization. This program should be authorized for the full 5 years of the next PAHPA reauthorization, along with the other preparedness programs.
  • -Section 2409 of the PREVENT Pandemics Act, which was signed into law as part of the FY23 final omnibus in December 2022, authorized a pilot program to support state medical stockpiles (Section 319F-2(i) of the Public Health Service Act). The authorization was for FY23 and FY24, however the legislation did not pass in time for funding to be allocated in FY23.
  • -ASPR and CDC are now authorized to award grants to 5 States, or consortia of States, to establish, expand or maintain a stockpile of drugs, vaccines, devices, and other medical supplies determined by the State to be necessary to respond to a public health emergency.
  • -To avoid duplication, these funds may not be used to stockpile security countermeasures, which are medical products developed through the Project BioShield program for national security threats and contained in the federal Strategic National Stockpile (SNS).
  • -Ensure that territories are included in Section 2409 of the PREVENT Pandemics Act during implementation of the authorized pilot program to support “state and territory medical stockpiles”.

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Support for Jurisdictional Preparedness and Response Capacity

• Promote consistent utilization of platforms for vaccine distribution and administration. For vaccines utilize VTrckS and for other MCMs use HPOP. Ensure lead responding agency is utilizing systems consistent with normal operations delivery.
• CDC and ASPR should review plans for vaccine distribution for future pandemics.
• Because minimum orders for the COVID-19 vaccine were so large, states had to break down shipments into smaller quantities and redistribute them to health care providers. This causes extra time between shipment to administration and is an additional break in the cold chain. It also continues to be costly for states to implement.
• Investments and guidance on surveillance reporting systems. States/Territories built systems from scratch for COVID-19 reporting, which took time. Guidance must include an emphasis on ensuring surveillance systems detect and data is used to address population disparities in disease and differences in healthcare access.
• Support the modernization of data systems (i.e., NHSN, IIS, disease surveillance), and reporting during public health emergencies must be prioritized in grants and funding. These systems are outdated and need automation and continued support.
  • -As an example, our disease surveillance system is not adequately funded for maintenance, let alone modernization. This system is the backbone for providing critical information during outbreaks like COVID-19.
• Reporting of COVID-19 deaths was manual, and a different CDC system was used than what is used for routine diseases surveillance. ASPR has limited the state program involvement to 15% of the total award requiring that hospitals perform these functions instead.
• This does not support a systems approach, and many hospitals do not want to take on this responsibility. Memorialize lines of communication and hierarchy for pandemic response, prompting clear communication between federal and state partners and a definitive governance structure around pandemic response.
• It is recommended that an Incident Command Structure or something like it encompass a whole-of-government approach and are not limited to HHS and ASPR, especially since many other federal agencies (U.S. Treasury, FEMA, Department of Education, etc.) were involved in providing guidance to states on pandemic-related issues.
• It was also suggested that using FEMA systems to store supplies, distribute funding and engage in related activities could cut down on duplication of work and effort while streamlining the process for states. Our local FEMA chapters had to do a lot of troubleshooting during the COVID-19 due to workforce shortages elsewhere.

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Medical Countermeasures Development and Deployment

• Continue to fund BARDA for the advancement and research of new medical countermeasures. Increased emphasis on stockpiling and development of diagnostic resources and specimen collection (swabs, VTM, etc.). Existing federal systems for immunizations and other medical countermeasures should be leveraged and enhanced to support distribution and dispensing of medical countermeasures.
• Set standards for equipment on hand (Stockpile and fund).
• Set standards for timely development and dissemination of testing to state and commercial labs. This was a lesson learned during Mpox and worked well. It is critical that there is access to testing and to engage the commercial and private sector earlier (compared to running everything through the state health departments which have limited capacity). However, it needs to be made clear that all testing needs to be reported to state health departments for surveillance purposes.
• Resource type medical capabilities inside FEMA for use with EMAC. Allowing resource awareness of availability nationwide.
• Provide standard reimbursement processes and develop training at all levels (federal, state, local, and the private sector.) Standardization is very important.
• Earlier and more research on effective interventions to address the spread of disease. Currently, there is limited evidence on what does and doesn’t work.
• Clearer guidance on vaccine prioritization at times when demand is high, and supply is low. States were left to decide who did and did not qualify for vaccines. When people heard that a given population in another state was eligible when that same population was ineligible in their state, it created hard feelings. More uniform and timely national guidance would have helped states better prioritize vaccine distribution.
• Ability to manufacture resources (i.e., PPE, ventilators) within the United States and not rely on imported resources which were in high demand and hampered our ability to respond to the pandemic early.
• Funding and workforce pre-planning should be baked into a long-term strategy for pandemic response activities. Hospitals, long-term care facilities, nursing homes and states should know what funding kicks in and what additional capacity is available to them once an emergency declaration goes into effect. States/Territories knew that from the FEMA perspective, but when they started to discover that they needed a lot more capacity across the board, it was a struggle. States/Territories can’t foresee the next pandemic/crisis but after so much money has gone out in response to one single pandemic, it may be difficult for Congress to provide similar funding in the near future for a public health emergency.
  • -Perhaps building voluntary health care worker commitments (specifically for traveling nurses and other high-in-demand health care professionals) and funding over time – knowing what we know now – and ensuring we have regular and required tabletop exercises for these scenarios as part of any relevant program agreements could be helpful. It’s important to also monitor shortages in the workforce and have more holistic remedies in place if possible before an emergency takes place so we can be prepared.

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Gaps in Current Activities & Capabilities

• Large-scale operational planning capability is beyond the scope of any single state/territorial agency. States/Territories depended upon a whole-of-government approach that included the National Guard, which was critical. There were barriers to being able to utilize the National Guard team in the beginning (authorization and funding) which were eventually remedied, but in an environment where the nation was seeing a shortage of health care workers and knowing that HHS alone could not resolve workforce issues through deployment of its contractors, that was a huge gap that states/territories would not have been able to overcome until those National Guard issues were remedied. Increasing the number of National Guard members with specific health care training is important, additionally providing opportunities for certifications and trainings in the health care field to rapidly address health care shortages in these areas in future public health emergencies. There is a need for a better plan or a larger pool of voluntary health care workers to draw from in the case that we face something similar to COVID-19 in the future.
• It would be more efficient and effective if ELC funding was more flexible. There are multiple projects with each having their own funding amounts and required activities. This results in split funding staff across multiple projects. It would be beneficial to us to be able to have the funding be more flexible within the cooperative agreement.
• While we understand the need to prioritize federal funding for community partners such as healthcare coalitions, hospitals, and local health departments, we also recognize the importance of recipient-level positions to develop meaningful grant applications, administer funding, monitor contracted work, and support community partners, and participate in agency-level response efforts. Current grant restrictions on the percent of awards allowed for recipient infrastructure unduly limits our ability to carry out this work.
• Appropriations for epidemiology and laboratory capacity (ELC) as well as emergency preparedness and response should be made as a block grant to states and not segmented by workstream (the ELC grant alone has 24 or more siloed program areas). State and local level programs have unique needs and know best how to allocate resources. It would save enormous time and effort on program management and financial accounting and would free up resources to do the actual work.
• Recognize and support efforts of states to maintain medical caches to respond to future emergencies.
  • -Some states maintain a sizeable medical cache which provided needed support to public health and medical partners during the COVID-19 pandemic, support that federal grantors may not be able to deliver during an emergency event.
• Federal decisions are being made about where patients will be routed to specialty care centers without input or consensus from the individual states or their stakeholders.
  • -For example, over the state’s objection, their state’s Ebola Treatment Center was established by ASPR with a hospital system placed in a different city. The state objected because most of their state’s hospital referrals go to a different hospital system, which is their standard referral pattern and is geographically closer to most of the state’s population.

Additionally, aside from currently authorized programs and activities, what gaps exist in HHS’ capabilities, and what types of activities or authorities are necessary for HHS to fulfill the intent of PAHPA and related laws?

• Need to establish a framework for day-to-day operations and during an emergency or major event. The current plans are not flexible enough to meet this type of demand.
• Response funds need to be deployed rapidly. For Monkeypox, the funds came after the outbreak was over creating an accounting burden on states. We have to abide by certain rules and budgets set by our state legislature, and there often is not a lot of flexibility without upfront emergency funding.
• Public health preparedness and response efforts would be more efficient and effective if these programs were amply funded to provide sustainable annual funding to mee the needs of a public health infrastructure ready to address all-hazards threats that await us. In contrast, administering supplemental and emergency funding is inefficient for recipients and does not promote the infrastructure building needed to promote resilient communities.
• The Counter Measure Injury Compensation Program in the PREP Act needs to be prepared to provide timely compensation to individuals injured due to countermeasures. This program is critical to ensuring confidence in countermeasures, including vaccines.
  • -Impacts the public’s trust in the system and fosters doubt about vaccine safety.
• The City Readiness Initiative (CRI) does not work in all states/territories. Each state/territory should be afforded the option to participate in this program.
  • -Funding for this program was carved out from the PHEP program to the detriment of the rest of the state.
  • -Federal grantors determined that only one city should receive the funding. Seven other cities had to reduce funding to create the CRI funding required for that area and reduced their response capacity.

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Partnerships

What specific steps could Congress take to improve partnerships with states and localities, community-based organizations, and private sector and non-government stakeholders, such as hospitals and health care providers, on preparedness and response activities? For example:

How can these entities be better supported in appropriately engaging with the federal government to understand available resources, capabilities, and expectations prior to, during, and following a public health emergency?

• Provide funding specific for trainings, conferences or planning activities between these entities.
• Host a conference/meeting within each FEMA Region bringing these entities to the same table (similar to what was just done for a FEMA Region V Flooding Seminar).
• Consistent and collaborative funding requirements.
• Increased coordination between HHS and DHS/FEMA to promote health-related incident command system (ICS), preparedness and response trainings funded by the federal government via training consortiums.
• Federal agencies can enhance communication and collaboration by building on existing partnerships and using those to expand to nontraditional partners whose engagement is critical during a public health emergency. Federal agencies should create engagement through existing, established relationships with traditional partners like emergency preparedness programs, and state and local leadership. Federal agencies should work in close collaboration with existing partners and thus build on those partnerships to engage with less traditional but critical stakeholders. Preparedness program and state and local leadership will have existing relationships and understand that state’s local ecosystem. These engagement efforts should begin prior to a public health emergency to enhance effectiveness during an emergency.
• During the pandemic, public health agencies and hospitals were held to high standards for data reporting, such as for bed availability, staffing, and medical supplies. HHS should develop and support a nationwide all-hazards reporting system that includes common reporting definitions that meets the needs of healthcare providers and public health agencies.
• Streamlining communication from federal agencies, or at least tightening coordination, prior to engagement would also be more helpful. At the federal level, the COVID-19 response appeared fragmented with competing interests among different parts of government. There were often conflicting messages from the CDC, HHS, FEMA, and the White House, which complicated the response at the state level. States were not often notified of major guidance before it was released at the federal level, which left states scrambling to communicate to the public while also interpreting its changes. Multiple reporting systems to different federal government agencies were also inefficient (i.e., hospital reporting of COVID-19 cases to the White House, other data reporting to the CDC). Written guidance (organized by subject area) from a single point of contact at the federal level should be available to state leadership, in addition to meetings, which are time consuming and often do not have minutes collated for easy dissemination. This can be a password protected site available to health/emergency response officials. Clearance processes at the federal level should be faster too.
• The spread of misinformation has been incredibly damaging and has been propagated at different levels of government. It has substantially undermined the trust in public health and science in general and hampered response to the pandemic at every step. There needs to be a robust and organized communications approach nationally to address misinformation on social media and elsewhere.
• Set standards that are based on capability of each hospital and listed group, then store information in a national database for easy access day-to-day.
• There needs to be more cross-training in database usage to include grants reimbursement training. There were agencies or entities that had never had to ask for FEMA reimbursement before, for example, and they were learning on the fly while spending the necessary funds to respond to the emergency.
• Combine the public health emergency preparedness agreements and hospital preparedness program into the State’s Emergency Management Agency or one lead entity to ensure continuity of effort and a statewide common operating picture for decision makers.
• Space inside of hospitals was a big unforeseen problem. Because of the need to separate infected patients, it expedited a hospital’s path to becoming overwhelmed. States/Territories had to stand up field hospitals and should be considered as a possible need for large-scale pandemic planning. Whether that is pre-designating certain areas or buildings with legal agreements or some other mechanism, or just making sure there is awareness around any standards used in the process of identifying/creating a field hospital.
• Ultimately, there was no whole-of-government playbook for how to deal with this, but the federal government should think about creating one based on best practices that surfaced in response to the pandemic.

How can foundational programs, such as the public health emergency preparedness cooperative agreements and the hospital preparedness program, be improved to ensure state, local, and health system readiness to mount effective responses?

• State health departments rely on HHS’ Public Health Emergency Preparedness (PHEP) and Hospital Preparedness Program (HPP) cooperative agreements to fund its public health infrastructure. HPP funding has dwindled in recent years and is far short of the levels needed to fully prepare our healthcare delivery system.
• PHEP and HPP funding requirements must be consistent with one another. Coordinate HPP requirements with hospital accreditation to align and complement one another ensuring there is no duplication of efforts by hospital and hospital systems. Recognize hospital systems in preparedness and response capabilities. Increased funding to support local and state preparedness activities related to PHEP and HPP programs. With the future of these programs, emphasis on comprehensive preparedness activities beyond traditional anthrax and pandemic planning. Activities should continue to support enhancement of core functions of health departments in dispensing and POD operations during public health emergencies. Other functions of public health in their lead role as ESF-8 should be emphasized, such as in natural hazards, radiation, chemical, MCI, etc. Review and feedback should be elicited from state and local jurisdictions in the development and evaluation of PHEP and HPP capabilities going forward.
• Establishing Health Care Coalitions is a requirement of the HPP. In rural states, with small populations, significant inefficiencies are created by establishing separate response coalitions.