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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.
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.
"Don't Ask, Don't Tell": The Law and Military Policy on Same-Sex Behavior
This report describes the "Don't Ask, Don't Tell" military policy, which holds that the presence in the armed forces of persons who demonstrate a propensity or intent to engage in same-sex acts would create an unacceptable risk to the high standards of morale, good order and discipline, and unit cohesion which are the essence of military capability. This report also describes recent efforts by certain Members of Congress to amending this policy.
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 regarding the H1N1 influenza, including emergency measures, civil rights, liability issues, and employment issues.
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.
Title X (Public Health Service Act) Family Planning Program
This report discusses various issues regarding the Family Planning Program, Title X of the Public Health Service Act. Enacted in 1970, it is the only domestic federal program devoted solely to family planning and related preventive health services.
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.
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.
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.
Federal Taxation of the Drug Industry and Its Effects on New Drug Development
This report examines the impact of federal taxation on the incentive to invest in new drug development. More specifically, it looks at the provisions in current tax law that affect the performance of the drug industry, compares the industry's federal tax burden with that of other major industries, and assesses the effect of federal taxation on the incentive to invest in new drug development.
Middle East Respiratory Syndrome (MERS-CoV): World Health Organization Responses
This report discusses responses to the recent outbreak of Middle East Respiratory Syndrome coronavirus (MERS-CoV), which has spread to more than a dozen countries.
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 U.S. Mental Health Delivery System Infrastructure: A Primer
This report begins with a historical perspective on delivery of mental health care services. Next, it describes the health care delivery system within which mental health care is currently provided and presents the various mechanisms that finance the current system. In describing the mental health system, this report considers three aspects: Who provides care? Where is the care provided? Who pays for the care? Finally, this report analyzes the barriers to receiving mental health treatment and workforce training issues, and presents possible options for Congress to address these barriers.
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.
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.
Medical Marijuana: Review and Analysis of Federal and State Policies
This report discusses the issue before Congress of whether to continue the federal prosecution of medical marijuana patients and their providers, in accordance with the federal Controlled Substances Act (CSA), or whether to relax federal marijuana prohibition enough to permit the medicinal use of botanical cannabis products when recommended by a physician, especially where permitted under state law.
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.
FDA Tobacco Regulation: The Family Smoking Prevention and Tobacco Control Act of 2009
This report focuses on the Family Smoking Prevention and Tobacco Control Act. It includes a brief discussion of the contrasting views of FDA tobacco regulation held by the public health community and the industry, and provides some analysis of a number of key regulatory issues that the bill raises.
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.
Intellectual Property Rights and Access to Medicines: International Trade Issues
This report focuses on the relationship between intellectual property right (IPR) provisions in international and U.S. trade policy and access to medicines. This issue represents one component of a broader debate about the relationship between trade policy and public health.
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.
Federal R&D, Drug Discovery, and Pricing: Insights from the NIH-University-Industry Relationship
This report explores the reasons behind government funding of research and development and subsequent efforts to facilitate private sector commercialization of the results of such work, without addressing issues associated with drug costs or pricing. It particularly looks at the manner in which the National Institutes of Health (NIH) supports research to encourage the development of new pharmaceuticals and therapeutics, particularly through cooperative activities among academia, industry, and government.
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.
End-of-Life Care: Services, Costs, Ethics, and Quality of Care
This report provides information on various aspects of end-of-life care: (1) demographic and historical changes affecting death and dying in the United States (2) the definitions of end-of-life, palliative, and hospice care (3) costs associated with end-of-life care (4) end-of-life care laws and ethics (5) quality of care at the end of life and (6) policy issues that would modify or expand the federal government's role in addressing end-of-life care.
Former NFL Players: Disabilities, Benefits, and Related Issues
This report discusses professional football players' injuries and health conditions that might have long-term consequences for their health.
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.
The Ryan White HIV/AIDS Program: Overview and Impact of the Affordable Care Act
This report discusses the impact of the Affordable Care Act on the Ryan White HIV/AIDS Program, which makes federal funds available to metropolitan areas and states to that provide a number of health care services for HIV/AIDS patients.
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.
AIDS: Ryan White CARE Act
This report discusses the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, which makes federal funds available to metropolitan areas and states to assist in health care costs and support services for individuals and families affected by the human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). This report discusses related legislation and appropriations.
AIDS: The Ryan White CARE Act
This report discusses the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, which makes federal funds available to metropolitan areas and states to assist in health care costs and support services for individuals and families affected by the human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). This report discusses related legislation and appropriations.
AIDS: The Ryan White CARE Act
This report discusses the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, which makes federal funds available to metropolitan areas and states to assist in health care costs and support services for individuals and families affected by the human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). This report discusses related legislation and appropriations.
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.
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.
Form 1099 Information Reporting Requirements as Modified by the Patient Protection and Affordable Care Act
This report discusses the modifications to IRC § 6041 made by § 9006 of the Patient Protection and Affordable Care Act (PPACA) and briefly discusses the penalties that can be imposed on persons that do not comply with these information reporting requirements.
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.
Medical Records Privacy: Questions and Answers on the HIPAA Rule
This report discuses the HIPAA privacy rule, which gives patients the right of access to their medical information and prohibits health plans and health care providers from using or disclosing individually identifiable health information without a patient’s written authorization except as expressly permitted or required by the rule.
AIDS Funding for Federal Government Programs: FY1981-FY1999
This report provides a synopsis of the budget activity related to AIDS from the discovery of the disease in 1981 through FY1999. Funding for AIDS research, prevention and treatment programs within the Department of Health and Human Services (HHS) discretionary budget has increased from $200,000 in FY1981 to an estimated $3.85 billion in FY1999.
Andean Counterdrug Initiative (ACI) and Related Funding Programs: FY2007 Assistance
This report is about the Andean Counterdrug Initiative (ACI) and related Funding Programs in the fiscal year 2007.
Direct-to-Consumer Advertising of Prescription Drugs
The Direct-to-Consumer advertising of perscription drugs by pharmaceutical companies has been described as any promotional effort with respect to these drugs that targets the general public through the lay media. This report contains information on growth in spending on direct-to-consumer prescription drug advertising, the impact of such advertising, the FDA's existing authority to regulate such advertising, funding, and legislative issues.
Health Insurance: A Primer
This report provides information about Health Insurance where people buy insurance to protect themselves against the possibility of financial loss in the future. Americans obtain insurance in different settings and a variety of methods.
Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests
In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or tissue, to provide information in making health care decisions. Examples of IVDs include pregnancy test kits or blood glucose tests for home use; laboratory tests for infectious disease, such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and tests for various genetic diseases or conditions. More recently, a specific type of diagnostic test--called a companion diagnostic--has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine. This report provides an overview of federal regulation of IVDs by FDA, through the Federal Food, Drug, and Cosmetics Act (FFDCA) and the Public Health Service Act (PHSA), and by CMS, through the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
Mental Health Parity and the Patient Protection and Affordable Care Act of 2010
This report provides a brief background on mental health parity and the policy discussion around parity in health insurance coverage; an overview of federal mental health parity law prior to the enactment of the ACA; and an analysis of the impact of the ACA.
Pharmaceutical Supply Chain Security
This report serves as a primer on pharmaceutical supply chain issues. It (1) describes the chain from manufacturer to patient, including where it is vulnerable; (2) summarizes current federal law, regulation, and FDA policies that Congress and the agency designed to protect the integrity of the final drug product, and indicates where those protections may falter; (3) notes state-level and professional association activities; and (4) discusses areas that Congress, FDA, and industry, health care, and patient stakeholders have suggested might be changed to increase the security of the pharmaceutical supply chain.
Title X (Public Health Service Act) Family Planning Program
This report discusses the Family Planning Program, Title X of the Public Health Service Act, through which the federal government provides grants for voluntary family planning services.
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.
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