The 2001 terrorist attacks, Hurricane Katrina, and concerns about an influenza ("flu") pandemic have sharpened congressional interest in the nation's systems to track and respond to public health threats. The 109th Congress passed laws that reauthorized public health and medical preparedness and response programs in the Department of Health and Human Services (HHS), and reorganized parts of the Department of Homeland Security (DHS), including the establishment of an Office of Health Affairs (OHA). This report discusses key issues in public health and medical preparedness and response, citing additional CRS reports and other resources

Lister, Sarah A.

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1  See CRS Report RL33589, The Pandemic and All-Hazards Preparedness Act (P.L. 109-417):Provisions and Changes to Preexisting Law, by Sarah A. Lister and Frank Gottron (hereafterCRS Report RL33589), and CRS Report RL33729, Federal Emergency Management Policy(continued...)Order Code RS22602Updated August 1, 2008Public Health and Medical Preparedness  and Response: Issues in the 110th CongressSarah A. ListerSpecialist in Public Health and EpidemiologyDomestic Social Policy DivisionSummaryThe 2001 terrorist attacks, Hurricane Katrina, and concerns about an influenza(“flu”) pandemic have sharpened congressional interest in the nation’s systems to trackand respond to public health threats.  The 109th Congress reauthorized or establishedrelevant programs in the Departments of Health and Human Services (HHS) andHomeland Security (DHS).  In its second session, the 110th Congress has focused itsoversight of these programs on (1) the fitness of HHS and DHS — in terms of authority,funding, policies, and workforce — to respond to complex health emergencies; (2) howwell they and other federal agencies coordinate their efforts; (3) the status of majorfederal initiatives, such as pandemic flu preparedness and disaster planning for at-riskpopulations; and (4) the effect of the upcoming presidential transition on authorities andprograms that were established during the current administration.  This report, whichwill be updated, discusses key issues in public health and medical preparedness andresponse, citing additional CRS reports and other resources.Background and Legislation in the 109th CongressThe Pandemic and All-Hazards Preparedness Act (PAHPA, P.L. 109-417), passedin 2006, extended programs for public health emergency preparedness and responseactivities in HHS, and established a Biomedical Advanced Research and DevelopmentAuthority (BARDA) in HHS to develop medical countermeasures (e.g., diagnostic tests,drugs, and vaccines).  The Post-Katrina Emergency Management Reform Act of 2006(PKA, Title VI of P.L. 109-295) reorganized DHS and, within it, the Federal EmergencyManagement Agency (FEMA).  PKA also codified the position of Chief Medical Officer,with primary responsibility within DHS for medical issues related to natural and man-made disasters and terrorism.1  CRS-21 (...continued)Changes After Hurricane Katrina: A Summary of Statutory Provisions, by Keith Bea,Coordinator (hereafter CRS Report RL33729).2 See HHS, Assistant Secretary for Preparedness and Response, at [http://www.hhs.gov/aspr], andDHS, Office of Health Affairs, at [http://www.dhs.gov/xabout/structure/editorial_0880.shtm].3 P.L. 109-295, 120 Stat. 1409;  P.L. 109-417, §101, 120 Stat. 2832.4 GAO, “Influenza Pandemic: Opportunities Exist to Clarify Federal Leadership Roles andImprove Pandemic Planning,” GAO-07-1257T, September 26, 2007.  See also CRS ReportRL33579, The Public Health and Medical Response to Disasters: Federal Authority andFunding, by Sarah A. Lister (hereafter CRS Report RL33579).5 See CRS Report RL33579.Issues in the 110th CongressFederal Leadership and Coordination.  Pursuant to PAHPA and PKA, HHS’sefforts are led by the Assistant Secretary for Preparedness and Response, and relatedactivities in DHS are led by the Assistant Secretary for Health Affairs and Chief MedicalOfficer.2  The PKA provided that the DHS Chief Medical Officer “shall have the primaryresponsibility within the Department for medical issues related to natural disasters, actsof terrorism, and other man-made disasters,” while PAHPA provided that the “Secretaryof [HHS] shall lead all Federal public health and medical response to public healthemergencies and incidents....”3 (Emphasis added.)  The Government AccountabilityOffice (GAO) noted, in the context of pandemic flu planning, that “... these leadershiproles involve shared responsibilities, and it is not clear how these would work inpractice.”4  GAO recommended that DHS and HHS conduct training and exercises toensure that federal leadership roles are clearly defined and understood.The Presidential Transition.  The transition to a new administration in January2009 will mark the first such transition for agencies and programs that were establishedfollowing the 2001 terrorist attacks.  These include the Office of the HHS ASPR and allof the newly established (versus “legacy”) agencies and programs in DHS, including theOffice of Health Affairs (OHA).  The transition may be especially challenging for OHA,which is in the midst of rapid growth in funding and staffing.  OHA was established (firstas the office of the Chief Medical Officer) in 2005, received $2 million in FY2006, andgrew to $117 million in FY2008, with $161 million requested for FY2009.  OHA is in theprocess of hiring permanent staff to carry out a variety of new responsibilities.HHS Response Capability.  The 110th Congress may consider the adequacy ofpermanent authorities of the HHS Secretary for responding to public health threats,including authority to declare a public health emergency.  Members of Congress may alsoconsider how HHS funds disaster response activities that are not reimbursable by FEMA.Though the HHS Secretary has authority for a no-year Public Health Emergency Fund,Congress has not appropriated monies to the fund for many years.5State Grants for Public Health and Hospital Preparedness.  Since 2002,Congress has provided more than $9 billion in grants to states to strengthen public healthand hospital preparedness for public health threats.  The PAHPA extended the programs,adding authority to withhold funds for failure to meet program requirements, a stateCRS-36 See CRS Report RL33589.7 See CRS reports on homeland security research and development at[http://apps.crs.gov/cli/cli.aspx?PRDS_CLI_ITEM_ID=589&from=3&fromId=19].8 See CRS Report RS21507, Project BioShield: Purposes and Authorities, by Frank Gottron;CRS Report RL33907, Project BioShield: Appropriations, Acquisitions, and PolicyImplementation Issues for Congress, by Frank Gottron; and CRS Report RL33589.9 See CRS Report RS22576, Pandemic Influenza: Appropriations for Public HealthPreparedness and Response, by Sarah A. Lister; CRS Report RL33145, Pandemic Influenza:Domestic Preparedness Efforts, by Sarah A. Lister; CRS Report RL34190, Pandemic Influenza:An Analysis of State Preparedness and Response Plans, by Sarah A. Lister and Holly Stockdale;CRS Report RL33219, U.S. and International Responses to the Global Spread of Avian Flu:Issues for Congress, by Tiaji Salaam-Blyther; CRS Report RL33795, Avian Influenza in Poultryand Wild Birds, by Jim Monke and M. Lynne Corn; CRS Report RL33871, Foreign Countries’Response to the Avian Influenza (H5N1) Virus: Current Status, by Emma Chanlett-Avery,Coordinator; and CRS Report RS22453, Avian Flu Pandemic: Potential Impact of TradeDisruptions, by Danielle Langton.matching requirement, and a requirement that the Secretary of HHS publish certaininformation about program activities and performance on a public website.6Biodefense Research.  Several federal agencies support biodefense research.These include the Science and Technology Directorate in DHS, the National Institutes ofHealth in HHS, the Department of Defense, and the U.S. Department of Agriculture(USDA).  The National Biodefense Analysis and Countermeasures Center (NBACC) wasrecently established by DHS to study biological threats, assess vulnerabilities andpotential consequences, and establish a national capability for forensic analysis ofevidence from bio-crimes and terrorism.  DHS has also requested funding to build a newfacility, the National Bio- and Agro-Defense Facility (NBAF), to house high-containmentlaboratories for the study of foreign animal diseases, such as Foot and Mouth Disease.7Project BioShield.  The 108th Congress launched Project BioShield to encouragethe development of countermeasures that lack commercial markets.  The 109th Congressrequired, in PAHPA, that the HHS Secretary develop and publish a strategic plan to guideHHS countermeasures research, development, and procurement.  PAHPA also establishedthe Biodefense Advanced Research and Development Authority (BARDA) in HHS tohelp implement the strategic plan, support countermeasure development, and facilitatecommunication between the government and developers.  The 110th Congress hasremained interested in the progress of Project BioShield and the establishment andeffectiveness of BARDA.8Pandemic Influenza Preparedness.  To prepare for the threat of a human flupandemic, the 109th Congress provided $6.1 billion in emergency supplemental fundingfor FY2006.  Most of this funding supports an HHS initiative to expand domestic vaccineproduction capacity. In addition to oversight of federal spending for pandemic flu,Congress may be interested in other matters, such as (1) federal coordination of pandemicpreparedness and response; (2) state, local, and private sector pandemic preparedness; (3)the impact of avian flu on affected countries; and (4) the possible effects of a flupandemic on global trade and commerce.9CRS-410 See “Federal Assistance for Disaster-Related Healthcare Costs,” in CRS Report RL33579, andCRS Report  RL33927, Selected Federal Compensation Programs for Physical Injury or Death,by Sarah A. Lister and C. Stephen Redhead.11 See, for example, H.R. 1414/S. 201, H.R. 1247, and H.R. 3543.12 See Government Accountability Office (GAO), Hurricane Katrina: Allocation and Use of $2Billion for Medicaid and Other Health Care Needs, GAO-07-67, February 28, 2007.13 See hearing on “Post Katrina Health Care: Continuing Concerns and Immediate Needs in theNew Orleans Region,” House Committee on Energy and Commerce, Subcommittee on Oversightand Investigations, March 13, 2007, and the Louisiana Healthcare Redesign Collaborative, at[http://www.dhh.louisiana.gov/offices/?ID=288].  See also CRS Report RL33579; CRS ReportRL33083, Hurricane Katrina: Medicaid Issues, by Evelyne P. Baumrucker et al.; and CRSReport RL33738, Gulf Coast Hurricanes: Addressing Survivors’ Mental Health and SubstanceAbuse Treatment Needs, by Ramya Sundararaman, Sarah A. Lister, and Erin D. Williams(hereafter CRS Report RL33738).14 See CRS Report RL33381, The Americans with Disabilities Act (ADA): Allocation of ScarceMedical Resources During a Pandemic, by Nancy Lee Jones.15 See GAO, Emergency Preparedness: States Are Planning for Medical Surge, but Could Benefitfrom Shared Guidance for Allocating Scarce Medical Resources, GAO-08-668,  June 13, 2008.16 See CRS Report RL33589.Disaster Victims and Health Care.  There is no federal assistance programdesigned purposely to cover the uninsured or uncompensated costs of individual healthcare that may be needed as a consequence of a disaster, nor is there consensus that thisshould be a federal responsibility.10  Faced with a catastrophic incident, hospitals,physicians, and other providers could be under considerable pressure to deliver care touninsured individuals without a clear source of reimbursement.  Proposals introduced inthe 110th Congress (H.R. 6569/S. 3312) would authorize the HHS Secretary to use aspecial fund to provide temporary emergency health care coverage for uninsuredindividuals affected by public health emergencies.  Several bills in the 110th Congresswould address the health care needs of responders and others who were exposed tohazards at the World Trade Center following the 2001 terrorist attack, and who are nowexperiencing health problems.11  Following Hurricane Katrina, Congress provided $2billion to cover the state share of Medicaid costs associated with evacuees and individualsliving in declared disaster areas (for states with approved federal waivers), and to restoreaccess to care in affected areas.12 The Louisiana Health Care Redesign Collaborative wasdeveloped to propose options for rebuilding the healthcare system in southern Louisianathrough a Medicaid waiver and Medicare demonstration proposal.13Health emergencies often involve scarcities of resources, including personnel,equipment, drugs, and vaccines.  Prioritizing the use of these resources to maximizebenefit requires careful study of scientific and medical evidence, and raises complex legaland ethical questions that are best considered before emergencies arise.14  Also, many areconcerned that the nation’s health care system, which is often overburdened by routinedemands, would not be able to handle surges in demand that could result from some typesof disasters.15  The PAHPA requires the HHS Secretary to assess national medicalresponse capability in a quadrennial National Health Security Strategy, and authorizesHHS to acquire mobile medical assets, such as field hospitals.16  Finally, Congress mayCRS-517 See CRS Report RL33738.18 See CRS Report RS22254, The Americans with Disabilities Act and Emergency Preparednessand Response, by Nancy Lee Jones; CRS Report RL33589; and CRS Report RL33729.19 See CRS Report RL33201, Federal and State Quarantine and Isolation Authority, by KathleenS. Swendiman and Jennifer K. Elsea; CRS Report RL34144, Extensively Drug-ResistantTuberculosis (XDR-TB): Emerging Public Health Threats and Quarantine and Isolation, byKathleen S. Swendiman and Nancy Lee Jones; CRS Report RL33609, Quarantine and Isolation:Selected Legal Issues Relating to Employment, by Nancy Lee Jones and Jon O. Shimabukuro;CRS Report RS22219, The Americans with Disabilities Act (ADA) Coverage of ContagiousDiseases, by Nancy Lee Jones; and CRS Report RS21414, Mandatory Vaccinations: Precedentand Current Laws, by Kathleen S. Swendiman.consider the effectiveness of programs to deliver mental health counseling services todisaster victims, and whether these services are well coordinated and well targeted.17Vulnerable Populations.  The terrorist attacks of 2001 and the hurricanes of 2005showed that some people may be at greater risk, or more in need of special services,during and following a disaster.  The PAHPA required the Secretary of HHS to consider,in planning, the needs of at-risk individuals, defined as children, pregnant women, seniorcitizens, and others as determined by the Secretary.  The PKA required the head of FEMAto appoint a Disability Coordinator, charged, among other things, with coordinatingemergency management policies and practices for individuals with disabilities.18Authorities to Control Communicable Diseases. The response tocommunicable disease threats may involve movement restrictions, business and schoolclosures, compulsory treatments, and other constraints. While state and local governmentshave the primary authority over these domestic containment measures, a comprehensiveresponse to a public health emergency may involve overlapping governmental authoritiesand attendant legal and economic issues.  Recent incidents have expanded Congress’slongstanding interest in the security of U.S. borders to include concerns aboutcommunicable diseases in travelers, which is a matter of federal jurisdiction.  Theseincidents have brought into question the divisions of authority and effectiveness ofcoordination among federal agencies that are responsible for disease control, and for thesecurity of the borders and the transportation infrastructure. Policy makers have noted thatif these systems are unable to respond to common and expected infectious disease threatssuch as tuberculosis, they may also be unable to respond to more serious threats such aspandemic flu or bioterrorism.  Effective solutions are elusive, but would ideally addressscientific, technical, and economic constraints; the balance of individual and collectiverights; and the roles of federal, state, and local authorities, and foreign governments.19Workforce Surge Capacity.  HHS manages several health professions programsgeared toward alleviating shortages and maldistributions of physicians, nurses, and otherswho provide individual health care services.  The public health workforce has, incontrast, received little federal attention until recently.  The PAHPA authorized a loanrepayment demonstration project for individuals who serve in state or local healthdepartments in defined areas of need. Other efforts to bolster the ranks of healthprofessionals for emergency response also include ensuring civil liability protection forvolunteer health professionals and establishing a system to verify their licenses andCRS-620 See CRS Report RS22255, Emergency Response: Civil Liability of Volunteer HealthProfessionals, by Kathleen Swendiman and Nathan Brooks; CRS Report RL32546, Title VIIHealth Professions Education and Training: Issues in Reauthorization, by BerniceReyes-Akinbileje (hereafter CRS Report RL32546); and CRS Report RL33589.21 See CRS Report RS22327, Pandemic Flu and Medical Biodefense Countermeasure LiabilityLimitation, by Henry Cohen and Vanessa K. Burrows.22 72 Federal Register 4710-4711, February 1, 2007.23 See CRS Report RL32917, Bioterrorism Countermeasure Development: Issues in Patents andHomeland Security, by Wendy H. Schacht and John R. Thomas, and CRS Report RL33159,Influenza Antiviral Drugs and Patent Law Issues, by Brian T. Yeh.24 See Congressional Budget Office, “Unauthorized Appropriations and Expiring Authorizations,”January 2008, at [http://www.cbo.gov/ftpdoc.cfm?index=8920&type=1].25 42 U.S.C. §262a and 7 USCS §8401.  See CDC Select Agent Program, at [http://www.cdc.gov/od/sap/], and APHIS Agricultural Select Agent Program, at [http://www.aphis.usda.gov/programs/ag_selectagent/].26 See CRS Report RL32546.27 See CRS Report RL33589.credentials. While efforts are ongoing among states and on the federal level, a uniformsystem for protection of volunteer health professionals does not yet exist.20Liability, Compensation, and Intellectual Property Issues.  In December2005, Congress passed Department of Defense Emergency Supplemental Appropriations,2006 (P.L. 109-148), including Division C, titled the “Public Readiness and EmergencyPreparedness Act” (PREP Act). Upon a declaration of emergency, the PREP Acteliminates liability, except in the case of willful misconduct, of manufacturers and othersinvolved in the production and use of countermeasures.21  In February 2007, HHSSecretary Leavitt made such a declaration with respect to pandemic flu vaccine.22  The lawalso establishes, in the U.S. Treasury, a “Covered Countermeasure Process Fund,” andrequires the HHS Secretary to develop a compensation mechanism for those who may beharmed by a covered countermeasure.  As of FY2008, the fund has not received anappropriation; none is requested for FY2009.  Finally, intellectual property protectionsmay affect the availability of countermeasures by making them more commerciallyattractive to developers, or more costly to purchasers, including governments.23Expired Program Authorities.  The 110th Congress may consider reauthorizationof some expired preparedness and response programs.24 Proposed legislation (S.3127/H.R. 6671) would reauthorize the Select Agent Program, which is jointly managedby the Centers for Disease Control and Prevention (CDC) and USDA’s Animal and PlantHealth Inspection Service (APHIS) to regulate certain biological pathogens and toxinsthat could be used for bioterrorism.  Program authority expired at the end of FY2007.25Authority for HHS health professions programs expired in 2002.  These programs havenot focused on emergency preparedness and response in the past, though the lastreauthorization in 1998 preceded heightened concerns in this area.26  Finally, authority forthe Strategic National Stockpile of countermeasures has been amended since the terrorattacks of 2001, but general program authority expired at the end of FY2006 and has notbeen extended.27

110th Congress

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