HHS FY 2018 Budget in Brief - PHSSEF
Public Health and Social Services Emergency Fund
The Public Health and Social Services Emergency Fund directly supports the nation’s ability to prepare for, respond to, and recover from the health consequences of naturally occurring and manmade threats.
Emergency Fund Budget Overview
(Dollars in millions)
|2016 /1||2017 /2/2||2018||2018
|Assistant Secretary for Preparedness and Response (ASPR)|
|Preparedness and Emergency Operations||25||25||25||--|
|National Disaster Medical System||50||50||50||--|
|Medical Reserve Corps||6||6||6||--|
| Biomedical Advanced Research and Development
|Policy and Planning||15||15||15||--|
|Subtotal, ASPR Program Level||1,431||1,400||1,375||-25|
|Other Office of the Secretary|
|Office of National Security (ONS) /3||8||8||8||--|
|Subtotal, Other Office of the Secretary||58||58||81||+22|
|Subtotal, Other Office of the Secretary||72||72||207||+135|
|Total Program Level, PHSSEF||1,561||1,530||1,663||+133|
|Total Budget Authority, PHSSEF||1,561||1,533||1,663||+133|
1/ In addition, the FY 2016 Zika Response and Preparedness Act provided $387 million in supplemental resources for Zika response and preparedness activities, including $245 million for BARDA, $75 million for CMS, and $66 million for HRSA.
2/ Reflects the annualized level of the Continuing Resolution that ended April 28, 2017, including the across the board reduction, the 21st Century Cures Act, and directed transfers.
3/ Totals reflect a realignment of $1.04 million from Cybersecurity to ONS to support the cyber threat activities carried out by ONS.
Within the Office of the Secretary, the Public Health and Social Services Emergency Fund directly supports efforts across the Government to safeguard the public and improve the Nation’s preparedness for acts of terrorism, natural disasters, and other threats to public health. The Fiscal Year (FY) 2018 Budget includes $1.7 billion, an increase of $133 million above FY 2017, to maintain and build on the Department’s capacity to address biodefense and cybersecurity needs, support state and local preparedness, and respond to emerging influenza viruses with pandemic potential.
Bioterrorism and Emergency Preparedness
The Department supports bioterrorism and emergency preparedness activities within the Office of the Secretary and across programs and agencies to enhance the Nation’s ability to prepare for, respond to, and recover from, a wide range of natural and man-made threats to public health. The Public Health and Social Services Emergency Fund supports the Department’s cross-cutting efforts to strengthen public health and medical preparedness, provide direct response to emergency situations, develop and procure medical countermeasures, and coordinate emergency preparedness policy and planning efforts across the Department of Health and Human Services (HHS).
Emergency Response Fund
The FY 2018 Budget proposes the establishment of an Emergency Response Fund to enable a swift response to emerging public health threats that have significant potential to affect the health and security of United States citizens. In addition to current transfer authority, HHS would have Department-wide transfer authority to support the Fund in the case of a natural or man-made disaster or threat. This Fund would be available to receive a transfer of up to one percent of any HHS account, without any limitation on the total, for use in emergency preparedness and response. Through this mechanism, HHS would have the ability to respond quickly when public health threats arise, as learned through previous public health threats such as Ebola and Zika. Such a fund will help bridge the Department’s response in situations that exceed the planned scope of preparedness and response programs and activities or where the emergency occurs late in the fiscal year.
Assistant Secretary for Preparedness and Response
The Assistant Secretary for Preparedness and Response (ASPR) is tasked with fulfilling HHS’s responsibilities as the lead Federal agency for public health emergency preparedness and response. ASPR fulfills these responsibilities by strengthening existing public health systems across the Nation, increasing the capacity of State and local governments to respond to public health threats, expanding advanced research, development and procurement of medical countermeasures, and providing operational leadership and policy development for a wide range of public health incidents.
The FY 2018 Budget includes $1.6 billion for ASPR, an increase of $110 million above the FY 2017 Continuing Resolution. The Budget prioritizes resources to support critical biodefense programs and maintain essential support for pandemic influenza preparedness and response. These investments fulfill a unique Federal role where no other entity is active in protecting the health and safety of the United States population.
The Budget includes $512 million—an increase of $1 million above the FY 2017 Continuing Resolution—for ASPR’s Biomedical Advanced Research and Development Authority (BARDA) to support the development of medical countermeasures that can mitigate potential health effects of chemical, biological, radiological, and nuclear agents and emerging infectious diseases. BARDA transitions medical product candidates, such as vaccines, antivirals, diagnostics, and medical devices, from early development into advanced development and regulatory approval. To maintain a robust product development pipeline and meet national demands during a public health emergency, BARDA routinely collaborates with Federal agencies and leverages unique public-private partnerships. These partnerships rely on core services that BARDA provides to aid medical countermeasure developers, including assistance with clinical study protocols and final product manufacturing.
Since its inception, BARDA has directly supported the development of over 80 chemical, biological, radiological, and nuclear medical countermeasure product candidates. The FY 2018 Budget will maintain a robust pipeline of candidate products that will transition to Project BioShield, and expand the portfolio of candidate products to address chemical, radiological, nuclear, and biological threats, including viral hemorrhagic fever viruses. BARDA also supports countermeasures to address influenza viruses. These efforts will attempt to address remaining gaps for these threats. Multiple candidates in the advanced development program will progress into Phase II and Phase III clinical studies, including broad spectrum antimicrobials, new treatments for radiation illnesses and thermal burns, and next-generation vaccines.
The Budget includes $510 million—an increase of $1 million above the FY 2017 Continuing Resolution—for Project BioShield to support late-stage development and procurement of high priority and novel medical countermeasures for the Strategic National Stockpile within the Centers for Disease Control and Prevention (CDC). At this funding level, BARDA will build on investments in the medical countermeasure development pipeline by purchasing promising products that are sufficiently mature and ready for use during a public health emergency. In FY 2018, Project BioShield will support the late-stage development and procurement of three new medical countermeasures, including products to address biological pathogens and antimicrobial resistance; lung injury resulting from exposure to chemical agents; and an intravenous formulation of a smallpox antiviral. In addition, the FY 2018 Budget will sustain the development and procurement of Ebola vaccines and therapeutics and the next generation anthrax vaccine, as well as maintain preparedness levels for chemical, smallpox, and nuclear medical countermeasures.
Hospital Preparedness Program
The Hospital Preparedness Program (HPP) enables health care systems to save lives during emergencies that exceed the day-to-day capacity of health and emergency response systems. The program has identified key reforms that, once implemented in FY 2018, will allow the program to be more efficient and effective in delivering results and protecting the health and lives of Americans.
One primary reform that will be implemented by the Hospital Preparedness Program is to transition to a competitive cooperative agreement program, by directing funds to States, jurisdictions, and Territories with the greatest need with respect to disaster preparedness. The introduction of a competitive cooperative agreement process will foster innovation and offer new opportunities for improved emergency preparedness and response, ensuring that the United States health care delivery system is better able to respond to emergencies that impact the public’s health. Additionally, the Hospital Preparedness Program will use risk-scores which identify the potential hazards and vulnerabilities, to direct resources to the States, jurisdictions, and Territories with the greatest need. The Hospital Preparedness Program’s risk score incorporates FEMA’s State and Homeland Security Program risk score, accounting for a range of factors including population and threat of terrorism. HPP will also incorporate a thorough assessment to account for natural disaster risk. Additionally, the program has identified methods that would directly link the cooperative agreement awards to performance. This new approach holds awardees accountable for improving performance by withholding funds from awardees that fail to deliver results.
The Hospital Preparedness Program enhances health care delivery system capabilities to ensure they have the training and resources available to respond to public health and medical emergencies swiftly and effectively. The reforms to this program work in concert to ensure that the Hospital Preparedness Program is delivering critical results for the American people in the most efficient and effective manner possible.
Since its inception, Project BioShield has supported the development and procurement of 21 novel medical countermeasures to address a wide range of threats such as anthrax, smallpox, botulism, viral hemorrhagic fever, and chemical, radiological, and nuclear agents. Six products have achieved Food and Drug Administration (FDA) approval, and BARDA anticipates an additional three products will be approved by FDA in FY 2018, in addition to five new products supported under Project BioShield. The sustainment of Project BioShield is fundamental in supporting the Nation’s ability to prepare for and respond to acts of terrorism, biological outbreaks such as Ebola, and other public health threats. Sustainment of the capabilities and capacity to manufacture these life-saving products is key to the continued success of Project BioShield.
The Budget includes $192 million—the same as the FY 2017 Continuing Resolution—to continue BARDA’s efforts to combat antibiotic-resistant bacteria. BARDA’s broad spectrum antimicrobial program will continue to leverage partnerships with public and private partners to develop products that directly support the government-wide National Action Plan for Combating Antibiotic-Resistant Bacteria. Most recently, BARDA has collaborated with the National Institutes of Health and the private sector to launch the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a trans-Atlantic public-private partnership focused on preclinical discovery and development of new antimicrobial products. To maximize the use of resources, the Budget proposes authority to transfer resources between ASPR’s advanced research and development and Project BioShield programs. This authority will better enable ASPR to manage resources across the advanced development and procurement stages to most effectively bring medical countermeasures through the pipeline.
Pandemic Influenza: H7N9 Response
Since the winter of 2016, a new strain of the H7N9 avian influenza virus, called the Yangtze River Delta lineage, has been circulating among birds in live poultry markets in China. This new lineage has led to more human cases of H7N9 infection in China than any prior H7N9 epidemic wave, with 623 human infections reported as of May 1, 2017. In addition, a growing number of viruses in this lineage have displayed genetic and antigenic changes that indicate greater pathology and greater resistance to current antiviral treatments. While the current risk to the United States public’s health posed by these new H7N9 viruses is low, the Department’s ongoing influenza risk assessment process has concluded that the pandemic potential is concerning.
To meet pandemic preparedness goals for the new H7N9 viral lineage, BARDA is collaborating with private industry and partners from the Public Health Emergency Medical Countermeasures Enterprise to develop a new H7N9 vaccine for the National Pre-pandemic Influenza Vaccine Stockpile. Using pandemic influenza appropriations, the Department is able to streamline this process by utilizing technology improvements in the development of vaccine seed strains as well as expanded domestic vaccine manufacturing surge capacity to procure vaccine in the event of a pandemic.
The Hospital Preparedness Program increases the ability of local, State and regional health care and emergency response systems to save lives during emergencies. Funding incentivizes diverse and often competitive health care organizations with differing priorities and objectives to work together through health care coalitions. Health care coalitions enable communities to develop comprehensive and collaborative health care response plans, ensure communities have the adequate health care resources and trained personnel to respond to a disaster, and conduct joint planning, exercises, and trainings to ensure operational readiness should disaster strike. The Budget includes $227 million, a decrease of $27 million below the FY 2017 Continuing Resolution, for ASPR’s Hospital Preparedness Program. The Hospital Preparedness Program works collaboratively with the CDC Public Health Emergency Preparedness program. The Hospital Preparedness Program focuses on incentivizing the private health care sector to prepare and respond while CDC’s Public Health Emergency Preparedness program focuses on strengthening the preparedness of the State and local governmental public health. These two programs complement each other to ensure that both the health care delivery system and public health departments are able to prepare for, respond to, and rapidly recover from, disasters. This year, the two programs will implement changes to improve the overall efficiency of each program. These reforms include a greater emphasis on risk assessment, which will direct resources to States and jurisdictions with the greatest need. Additionally, the programs will innovate through competition, funding the most effective preparedness strategies and aligning awardees more closely with program missions to improve the Nation’s health. Lastly, the new reforms will use these resources wisely and with accountability by tying continued funds to performance, providing awards to those recipients who are demonstrating results, and improving the overall capabilities of emergency preparedness and response systems.
The FY 2018 Budget maintains $50 million to support the National Disaster Medical System. The National Disaster Medical System consists of approximately 5,000 intermittent Federal employees who stand ready to deploy as trained medical teams to provide essential medical services in communities across the nation when a disaster or public health emergency occurs. Each deployment not only provides trained medical professionals to support the response efforts, but also sends the necessary medical supplies and equipment to ensure the impacted community has the tools necessary to expedite recovery efforts. To improve the efficiency and effectiveness of the program, the National Disaster Medical System has restructured responder requirements and team configurations so that the deployed teams are better able to meet the needs of the States and localities impacted by a disaster.
The FY 2018 Budget maintains ASPR’s management of the Medical Reserve Corps by providing $6 million to support these activities, which is the same as the FY 2017 Continuing Resolution. Complementing the National Disaster Medical System, the Medical Reserve Corps consists of over 200,000 volunteers, organized into almost 1,000 community-based groups, ready to serve within their locality to build community resilience through education and prevention activities, improve local preparedness, response, and recovery capabilities, and provide behavioral health support, when necessary. Additionally, the FY 2018 Budget supports ASPR’s Office of Emergency Management which manages the necessary assets to support ASPR’s response activities while coordinating the logistics necessary to ensure that each of ASPR’s preparedness and response efforts have the right resources in the right place at the right time.
The continued emergence of novel influenza viruses with human pandemic potential demonstrates the critical need for pandemic influenza preparedness activities, including the production of influenza countermeasures. Previous investments in domestic influenza vaccine manufacturing facilities and pre-pandemic influenza vaccine stockpiles have successfully increased the Department’s capacity to respond to emerging and evolving influenza viruses that pose a significant threat to public health. The FY 2018 Budget continues to invest in this critical capacity within HHS with a total of $207 million, an increase of $135 million above the FY 2017 Continuing Resolution, to support influenza vaccine manufacturing and stockpiling, international preparedness, and the advanced development of novel influenza vaccines, antivirals, and diagnostics. These efforts are supported by BARDA and the Office of Policy and Planning within ASPR and through the Office of Global Affairs. BARDA is currently supporting the manufacturing and stockpiling of a new vaccine in response to the H7N9 avian influenza virus in China, which has caused 623 human infections during its fifth epidemic wave, the largest epidemic wave of the virus to date.
Department-wide Information Security
Security and Strategic Information
The FY 2018 Budget includes $8 million for the Office of Security and Strategic Information. A realignment of $1 million was made from Cybersecurity to the Office of Security and Strategic Information to support cyber threat activities. The Office of Security and Strategic Information keeps Americans safe by integrating and synthesizing information on public health, terrorism, homeland security, and other health threats for HHS activities. The program increases the Department’s security awareness by developing and implementing strategies to reduce national security threats. The Office coordinates information sharing and safeguarding not only across HHS, but also with the Director of National Intelligence, other Federal partners, and agencies within the intelligence community.
The FY 2018 Budget includes $72 million for the HHS cybersecurity program, $22 million above the FY 2017 Continuing Resolution. The Department’s cybersecurity efforts are critical to protecting HHS’s mission. The program works to ensure that HHS is able to address the evolving cyber threats and protect the Department’s sensitive information. The cybersecurity program will continue its operations to detect, manage, and remediate cybersecurity risks. The cybersecurity program has a unique Federal role, maintaining the security of information for other HHS entities. The activities of the cybersecurity program safeguard the Department’s unique data, ranging from FDA’s proprietary information, CMS’s financial records, and extensive personal health information across the Department. The additional resources will in part be directed to expand HHS’s capability to share cybersecurity threat indicators and information across the Federal and private health care spaces to better protect the security of such data.