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2009 H1N1 "Swine Flu": CRS Experts
This report includes a table which provides access to names and contact information for CRS experts on policy concerns relating to swine influenza A virus (H1N1). Policy areas identified include: Identification, diagnosis, and surveillance of the virus; Treatment and prevention: antiviral drugs (Tamiflu, Relenza) and vaccines; Declarations of emergencies; Official plans and organizational responsibilities; and Restrictions on travel and trade.
The 2009 H1N1 "Swine Flu" Outbreak: An Overview
This report provides an introduction to the situation regarding the potential of a global human influenza pandemic caused by the new H1N1 flu strain. It includes a brief chronology of events; a discussion of key actions taken and authorities invoked by the WHO and the U.S. government; and information about key U.S. government pandemic flu planning documents.
The 2009 Influenza A (H1N1) "Swine Flu" Outbreak: An Overview
This report provides an overview of key actions taken and authorities invoked by WHO and the U.S. government. First, it discusses the WHO process to determine the phase of a threatened or emerging flu pandemic and touches on a number of related issues. The report then examines actions taken by the Departments of Homeland Security and Health and Human Services and provides information about appropriations and funding for pandemic flu activities.
Human Cloning
This report discusses human cloning science and federal policy regarding human embryo research. It provides background on the topic, federal policies, state laws, Congressional actions, and ethical issues.
Smallpox Vaccine Injury Compensation
This report discusses the Public Safety Officers’ Benefits Program, which provides for compensation of individuals injured by vaccinations given as part of a countermeasure plan declared by the Secretary of Health and Human Services in preparation for potential hostile activities involving the smallpox virus.
Military Medical Care: Questions and Answers
This report attempts to answer basic questions about defense health care, its beneficiary population, the medical services it provides, its costs, and major changes that are underway or have been proposed.
Selected Health Funding in the American Recovery and Reinvestment Act of 2009
The American Recovery and Reinvestment Act (ARRA) of 2009, which the President signed into law on February 17, 2009, provided more than $17 billion in supplemental FY2009 discretionary appropriations for biomedical research, public health, and other health-related programs within the Department of Health and Human Services (HHS). This report discusses the health-related programs and activities funded by ARRA, including details of how the administering HHS agencies and offices plan to allocate, award, and spend the funds.
Selected Health Funding in the American Recovery and Reinvestment Act of 2009
This report compares funding provided for selected Health and Human Services (HHS) programs in the American Recovery and Reinvestment Act (ARRA) conference report (H.Rept. 111-16) with the recommendations in the House- and Senate-passed versions of H.R. 1. It also briefly discusses ARRA's provisions on HIT and comparative effectiveness research as they relate to the funding.
Military Medical Care: Questions and Answers
This report attempts to answer basic questions about defense health care, its beneficiary population, the medical services it provides, its costs, and major changes that are underway or have been proposed.
Military Medical Care: Questions and Answers
This report answers several frequently-asked questions about military health care, including: how the system is structured, a TRICARE summary, TRICARE eligibility and plan options, cost of military health care to beneficiaries, relationship of TRICARE to MEDICARE, how the Affordable Care Act affects TRICARE, long-term trends of defense health care costs, and a summary of the fund which funds TRICARE (the Medicare Eligible Retiree Health Care fund).
Military Medical Care: Questions and Answers
This report answers several frequently-asked questions about military health care, particularly related to TRICARE and its various aspects.
Military Medical Care: Questions and Answers
This report answers several frequently asked questions about military health care, including: how the system is structured, a TRICARE summary, TRICARE eligibility and plan options, cost of military health care to beneficiaries, relationship of TRICARE to MEDICARE, how the Affordable Care Act affects TRICARE, long-term trends of defense health care costs, and a summary of the fund which funds TRICARE - the Medicare Eligible Retiree Health Care fund.
Federal R&D, Drug Discovery, and Pricing: Insights from the NIH-University-Industry Relationship
Interest in methods to provide drugs at lower cost, particularly for the elderly, has rekindled discussion over the role the federal government plays in facilitating the creation of new pharmaceuticals for the marketplace. This report explores the issue of whether or not the substantial federal investment in health-related research and development (R&D) entitles the public to commensurate consideration in prices charged for any resulting drugs. It is intended to provide the reader with an understanding of the rationale for government support of R&D and subsequent efforts to facilitate private sector commercialization of new technologies generated from such work. Concerns surrounding innovation in pharmaceuticals and biotechnology are discussed within the broader context of the federal role in facilitating technological progress.
Medicare Physician Payment Updates and the Sustainable Growth Rate (SGR) System
This report provides a background on the Medicare fee schedule, the SGR system and the annual updates, and discusses recent proposals to address this issue.
Centers for Disease Control and Prevention Global Health Programs: FY2001-FY2010
This report explains the role the Centers for Disease Control and Prevention (CDC) plays in U.S. global health assistance, highlights how much the agency has spent on global health efforts from FY2001 to FY2010, and discusses how funding to each of its programs changed during this period.
Health Care Reform: An Introduction
This report provides an introduction to health care reform. It focuses on the three predominant concerns just mentioned--coverage, cost and spending, and quality--and some of the legislative issues within which they likely will be debated, including the scope of reform (particularly whether Medicare and Medicaid should be included); the choice between public and private coverage; whether employment-based insurance should be strengthened, weakened, or left alone; and what role states might play.
Direct-to-Consumer Advertising of Prescription Drugs
This report describes the current status of direct-to-consumer (DTC) drug advertising; analyzes issues surrounding it; and discusses potential options for Congress.
The Role of the Department of Defense During A Flu Pandemic
This report focuses on the role of the Department of Defense (DOD) in supporting the nation's domestic response effort to a flu pandemic, although it will also touch on DOD's international role.
Pandemic Flu and Medical Biodefense Countermeasure Liability Limitation
This report analyzes Division C of the Department of Defense Emergency Supplemental Appropriations, P.L. 109-148, which was signed into law on December 30, 2005, and which limits liability with respect to pandemic flu and other public health countermeasures.
Veterans' Health Care Issues in the 109th Congress
This report provides an overview of major issues facing veterans' health care during the 109th Congress. The report's primary focus is on veterans and not military retirees.
Overview of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
This report examines the the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which creates a prescription drug benefit for Medicare beneficiaries and establishes a new Medicare Advantage program to replace the current Medicare+Choice program.
Patient Safety: Legislation to Promote Voluntary Reporting of Medical Errors
This report provides an overview and some analysis of the patient safety legislation that is being considered by the 108th Congress. It begins with background information on the nature and causes of medical errors, followed by a brief comparison of the differences between mandatory and voluntary reporting systems. The report then discusses some of the legal and policy issues facing state mandatory reporting systems and major national voluntary reporting systems, and identifies design features of effective reporting programs. It concludes with a discussion and side-by-side comparison of H.R. 663 and S. 720.
Military Health Care: The Issue of “Promised” Benefits
In the debate over the Department of Defense policy on military health care benefits, many military personnel and retirees say that they were promised “free health care for life” when they entered the armed forces. What benefits are available and who is eligible to receive these benefits are matters determined by Congress. This report discusses the issue of “promises” of lifetime health care benefits made to military retirees.
The Public Health and Medical Response to Disasters: Federal Authority and Funding
This report examines, first, the authorities and coordinating mechanisms of the President and the Secretary of HHS in providing routine assistance, and assistance pursuant to emergency or major disaster declarations and/or public health emergency determinations; second, mechanisms to assure a coordinated federal response to public health and medical emergencies, and overlaps or gaps in agency responsibilities; and finally, existing mechanisms, potential gaps, and proposals for financing the costs of a response to public health and medical emergencies.
The Public Health and Medical Response to Disasters: Federal Authority and Funding
This report examines (1) the authorities and coordinating mechanisms of the President and the Secretary of Health and Human Services (HHS) in providing routine assistance, and assistance pursuant to emergency or major disaster declarations and/or public health emergency determinations; (2) mechanisms to assure a coordinated federal response to public health and medical emergencies, and overlaps or gaps in agency responsibilities; and (3) existing mechanisms, potential gaps, and proposals for financing the costs of a response to public health and medical emergencies.
The 2009 Influenza Pandemic: Selected Legal Issues
This report provides a brief overview of selected legal issues regarding the H1N1 influenza, including emergency measures, civil rights, liability issues, and employment issues.
The 2009 Influenza Pandemic: Selected Legal Issues
This report provides a brief overview of selected legal issues regarding the H1N1 influenza, including emergency measures, civil rights, liability issues, and employment issues.
Animal Identification: Overview and Issues
This report provides information about animal identification and proposed solutions. Livestock industry groups, animal health officials, and the U.S. Department of Agriculture (USDA) have been working to establish a nationwide identification (ID) system capable of quickly tracking animals from birth to slaughter, to deal with animal diseases and/or to satisfy foreign market specifications. Some consumer groups are among those who believe ID also would be useful for food safety or retail labeling purposes.
Follow-On Biologics: Intellectual Property and Innovation Issues
This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.
The 2009 Influenza Pandemic: Selected Legal Issues
Recent human cases of infection with a novel influenza A(H1N1) virus have been identified both internationally and in the United States. Since there has been human to human transmission and the new virus has the potential to become pandemic, it is timely to examine legal issues surrounding this emerging public health threat. This report will provide a brief overview of selected legal issues.
The 2009 Influenza Pandemic: Selected Legal Issues
This report provides a brief overview of selected legal issues including emergency measures, civil rights, liability issues, and employment issues.
The 2009 Influenza Pandemic: Selected Legal Issues
This report provides a brief overview of selected legal issues including emergency measures, civil rights, liability issues, and employment issues.
The 2009 Influenza Pandemic: Selected Legal Issues
Recent human cases of infection with a novel influenza A(H1N1) virus have been identified both internationally and in the United States. Since there has been human to human transmission and the new virus has the potential to become pandemic, it is timely to examine legal issues surrounding this emerging public health threat. This report will provide a brief overview of selected legal issues.
FDA Regulation of Follow-On Biologics
This report provides a brief introduction to the relevant law regarding follow-on biologics, the regulatory framework at the FDA, the scientific challenges for the FDA in considering the approval of follow-on biologics, and a description of the proposed legislation.
The Public Health and Medical Response to Disasters: Federal Authority and Funding
This report examines (1) the authorities and coordinating mechanisms of the President and the Secretary of HHS in providing routine assistance, and assistance pursuant to emergency or major disaster declarations and/or public health emergency determinations; (2) mechanisms to assure a coordinated federal response to public health and medical emergencies, and overlaps or gaps in agency responsibilities; and (3) existing mechanisms, potential gaps, and proposals for financing the costs of a response to public health and medical emergencies.
Stem Cell Research: Ethical Issues
This report discusses the ethical arguments that surround human embryonic stem cell research (ESR). Human stem cell research is controversial not because of its goals, but rather because of the means of obtaining some of the cells.
The 2009 Influenza A(H1N1) "Swine Flu" Outbreak: U.S. Responses to Global Human Cases
This report discusses the April 2009 outbreak of the influenza strain known as H1N1, or swine influenza. This report describes the distribution of the virus and the statistics of affected areas, as well as international and U.S. efforts to treat infected persons, respond to outbreaks in various countries, and prepare for a possible influenza pandemic.
Stem Cell Research
This report provides background on the research and potential applications of research that uses embryonic and adult stem cells. It also provides information about the current federal and state regulatory landscape, related Congressional and international actions, and relevant ethical concerns.
Medical Malpractice Liability Reform: H.R. 5, 109th Congress
This report discusses H.R. 5, which would preempt state law regarding some aspects of medical malpractice liability and liability for defective medical products, including drugs. The legislation would among other things, place caps on noneconomic and punitive damages (in states that have not enacted and do not enact caps), eliminate joint and several liability, modify the collateral source rule, limit lawyers' contingent fees, enact a federal statute of limitations, and provide for periodic payment of future damages.
Medicare Prescription Drug Proposals: Estimates of Aged Beneficiaries Who Fall Below Income Criteria, by State
This report discusses bills related to Medicare benefits, which include additional assistance for low-income beneficiaries. The assistance would have been in the form of reduced, subsidized or eliminated premiums, deductibles and other cost-sharing. Proposals in the 108th Congress will probably also include some of these features for low-income beneficiaries.
Background and Legal Issues Related to Stem Cell Research
This report discusses issues regarding stem cell research. With certain restrictions, the President has announced that federal funds may be used to conduct research on human embryonic stem cells. Federal research is limited to "the more than 60" existing stem cell lines that were derived (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. No federal funds will be used for the derivation or use of stem cell lines derived from newly destroyed embryos; the creation of any human embryos for research purposes; or cloning of human embryos for any purposes.
Stem Cell Research
This report provides background on the research and potential applications of research that uses embryonic and adult stem cells. It also provides information about the current federal and state regulatory landscape, related Congressional and international actions, and relevant ethical concerns.
Prescription Drug Coverage Under Medicaid
Medicaid is a joint federal-state entitlement program that pays for medical services on behalf of certain groups of low-income persons. It is the third largest social program in the federal budget, exceeded only by Social Security and Medicare and is typically the second largest spending item for states. This report discusses prescription drug policies under the program.
Genetic Exceptionalism: Genetic Information and Public Policy
This report provides an overview of the nature of genetic information and its implications for individuals, family, and society. Individuals utilize genetic information to guide health care and other decisions, when possible, and may experience anxiety as a result of genetic test results. Genetic test results for an individual may often be informative for other close family members and thus influence their care decisions. Society must grapple with the effect genetic information may have on our conception of disease, as well as its impact on issues like privacy and equity. The report ends by summarizing the main policy issues involved with a genetic exceptionalist approach to public policy, including defining genetic information; physically separating genetic information from other medical information; unintended disparities between “genetic” and “nongenetic” disease; and the effect of legislation on participation in genetic research, on uptake of genetic technology and on the delivery of high quality health care.
Food Labeling: Allergy Information
Media attention to food allergies is the result of the recent tracking of food allergy sufferers and a clear rise in the number of affected individuals. Several efforts are underway to improve the ability of individuals who have a food allergy to avoid products that cause symptoms that can range from mild to serious. The Food and Drug Administration (FDA) and the Food Allergy Issues Alliance each have released guidelines to address the issues of labeling and cross-contamination. Nine state attorneys general have petitioned FDA for stricter rules, which are also supported by some consumer groups. The FY2002 agriculture appropriations bill directed FDA to address and report on cross-contamination; however, this report had not yet been submitted. Most recently, the Food Allergen Labeling and Consumer Protection Act of 2004 (P.L. 108-282) was enacted on August 2, 2004. This report will provide background on food allergies and review efforts to provide improved labeling information for food allergy sufferers; it will be updated to reflect legislative or other activity.
Influenza Antiviral Drugs and Patent Law Issues
This report examines the role that intellectual property rights play in affecting the availability of a patented drug such as Tamiflu during public health crises. The report also explains one legal mechanism for increasing a patented drug’s production without the patent holder’s consent: governments may abrogate a pharmaceutical company’s patent rights by issuing compulsory licenses to other drug companies to manufacture generic versions of the drug.
Public Health and Medical Preparedness and Response: Issues in the 111th Congress
This report summarizes key issues in domestic public health and medical preparedness and response, citing other CRS Reports and sources of additional information. Key recent events--the 2001 terrorist attacks, Hurricane Katrina, and concerns about an influenza ("flu") pandemic, among others--sharpened congressional interest in the nation's systems to track and respond to public health threats.
Funding Plant and Animal Health Emergencies: Transfers from the Commodity Credit Corporation
This report examines the Secretary of Agriculture's authority to transfer funds from the Commodity Credit Corporation (CCC) to the Animal and Plant Health Inspection Service (APHIS) for emergency control programs. The Secretary’s use of this authority has increased in recent years, and has become an issue within government concerning the method for funding plant and animal health programs.
The Federal Food Safety System: A Primer
Numerous federal, state, and local agencies share responsibilities for regulating the safety of the U.S. food supply, which many experts say is among the safest in the world. Nevertheless, critics view this system as lacking the organization and resources to adequately combat foodborne illness, which sickens an estimated 76 million people and kills an estimated 5,000 each year in this country. The 110th Congress may face calls for a review of federal food safety agencies and authorities, and proposals for reorganizing them. Among the issues likely to arise are whether reform can improve oversight, and the cost to industry, consumers, and taxpayers. This report provides a brief introduction to the system and the debate on whether reorganization is needed.
The 2009 Influenza Pandemic: An Overview
This report first provides a synopsis of key events, actions taken, and authorities invoked by World Health Organization (WHO), the U.S. federal government, and state and local governments.