Congressional Research Service Reports - 197 Matching Results

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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.
The Veterans Health Administration and Medical Education: A Fact Sheet
This report supplies facts about the Veterans Health Administration and its medical education. It describes the US Department of Veterans Affairs (VA) and its involvement in the medical training of health care professionals. The report also gives details on the VA's academic affiliations, its funding of physician training, and its ongoing graduate medical education (GME) expansion. Figure 1 on page 3 shows the amount the VA spent on education and training from FY2010 to FY2015.
Health Care for Veterans: Suicide Prevention
This report focuses on suicide prevention activities of the Veterans Health Administration (VHA) within the Department of Veterans Affairs (VA). The VHA's approach to suicide prevention is based on a public health framework, which has three major components: (1) surveillance, (2) risk and protective factors, and (3) interventions.
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.
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 FDA Medical Device User Fee Program: MDUFA IV Reauthorization
This report describes current law regarding medical device user fees, the impact of Medical Device User Fee and Modernization Act (MDUFMA) on Federal Drug Administration (FDA) review time of various medical device applications, and the agency's medical device program budget.
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.
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.
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.
Hospital Cost Containment
This report provides an overview of the dimensions of the problem of rising expenditures for hospital care, the reasons for rising hospital costs, general information on methods of controlling hospital costs and specific programs which have been developed, and some of the issues involved.
Heroin: Legalization for Medical Use
This report discusses the limited legalization of diacetylmorphine (heroin) for use in the medical treatment of intractable pain. The report attempts to present pros and cons on the issue as well as information on pending legislation. The report also provides a comparison of heroin's analgesic qualities to those of currently available and equivalent pharmaceutical alternatives.
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.
Immigration Policies and Issues on Health-Related Grounds for Exclusion
This report discusses the criteria that foreign nationals must meet before admission to the United States including the reasons why a foreign national might be denied admission, most particularly on health-related grounds. It describes this issue in relation to the recent outbreak of the 2009 H1N1 ("swine flu") virus, and how the outbreak has affected various government agencies, such as the Customs and Border Protection (CBP) agency within the Department of Homeland Security (DHS). This report also discusses efforts to confront and address related issues on a legislative front.
Prescription Drug Monitoring Programs
This report looks at ways that prescription drug monitoring programs (PDMPs), which maintain statewide electronic databases of prescriptions dispensed for controlled substances, can help to deter prescription drug misuse.
The Number of Veterans That Use VA Health Care Services: A Fact Sheet
This report provides data on the number of veterans and VA health care users, and discusses the allegations of long delays in treatments.
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.
Legal Issues Relating to the Disposal of Dispensed Controlled Substances
This report describes an issue that is the fastest-growing drug problem in the country -- the intentional use of prescription drugs for non-medical purposes. It is the second-most common form of illicit drug abuse among teenagers in the United States behind marijuana use. Several bills have been introduced in the 111th Congress that would create a legal framework governing disposal of controlled substances that have been dispensed to patients.
Legal Issues Relating to the Disposal of Dispensed Controlled Substances
Prescription drug abuse is the second-most common form of illicit drug abuse among teenagers in the United States, trailing only marijuana use. Prescription drug abuse has become a particular concern amongst federal policymakers. This report discusses this issue, including related pieces of legislation such as the Controlled Substances Act, the Secure and Responsible Drug Disposal Act of 2010, and the proper way to dispose of controlled substances.
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.
TRICARE and VA Health Care: Impact of the Patient Protection and Affordable Care Act (PPACA)
This report addresses key questions concerning how the Patient Protection and Affordable Care Act (PPACA) affects TRICARE and VA health care.
Veterans Affairs: Presumptive Service Connection and Disability Compensation
The purpose of this report is to examine the very complex and sometimes controversial policy issue of establishing presumptive service connection. The material in it is based in large part on VA’s “Analysis of Presumptions of Service Connection,” and IOM’s “Improving the Presumptive Disability Decision-Making Process for Veterans” reports.
Veterans Medical Care: FY2011 Appropriations
The Department of Veterans Affairs (VA) provides benefits to veterans through three major operating units, one of which is the Veterans Health Administration (VHA), on which this report focuses. This report will track the FY2011 appropriations process for funding VHA, and will be updated as legislative activities warrant.
Veterans Medical Care: FY2011 Appropriations
This report discusses the FY2011 appropriations process for funding the Veterans Health Administration (VHA). The Department of Veterans Affairs (VA) provides benefits to veterans through three major operating units, including the VHA.
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.
Prescription Drug Monitoring Programs
This report looks at ways that prescription drug monitoring programs (PDMPs), which maintain statewide electronic databases of prescriptions dispensed for controlled substances, can help to deter prescription drug misuse.
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.
Frequently Asked Questions About Prescription Drug Pricing and Policy
This report will address frequently asked questions about government and private-sector policies that affect drug prices and availability. Among the prescription drug topics covered are federally funded research and development, regulation of direct-to-consumer advertising, legal restrictions on reimportation, and federal price negotiation. The report provides a broad overview of the issues as well as references to more in-depth CRS products. The appendixes provide references to relevant congressional hearings and documents (see Appendix A) and a directory of CRS prescription drug experts (see Appendix B).
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. This report discusses various food safety proposals in Congress, as well as agencies with food safety related responsibilities.
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 Federal Food Safety System: A Primer
This report discusses concerns about food safety, the resources required to ensure food safety, and whether federal food safety laws themselves, first enacted in the early 1900s, have kept pace with the significant changes that have occurred in the food production, processing, and marketing sectors since then.
The Federal Food Safety System: A Primer
The combined efforts of the food industry and the regulatory agencies often are credited with making the U.S. food supply among the safest in the world. Nonetheless, many food-related health issues persist. At issue is whether the current U.S. regulatory system has the resources and structural organization to protect consumers from these dangers. Also at issue is whether the federal food safety laws themselves, first enacted in the early 1900s, have kept pace with the significant changes that have occurred in the food production, processing, and marketing sectors since then.
The Federal Food Safety System: A Primer
Report concerning food safety, the resources required to ensure food safety, and whether federal food safety laws themselves, first enacted in the early 1900s, have kept pace with the significant changes that have occurred in the food production, processing, and marketing sectors since then.
The Federal Food Safety System: A Primer
The combined efforts of the food industry and the regulatory agencies often are credited with making the U.S. food supply among the safest in the world. Nonetheless, many food-related health issues persist. At issue is whether the current U.S. regulatory system has the resources and structural organization to protect consumers from these dangers. Also at issue is whether the federal food safety laws themselves, first enacted in the early 1900s, have kept pace with the significant changes that have occurred in the food production, processing, and marketing sectors since then.
Comparison of the Current World Trade Center Medical Monitoring and Treatment Program and the World Trade Center Health Program Proposed by Title I of H.R. 847
This report compares the current federally supported medical screening and treatment program offered to various persons affected by the terrorist attack on New York City on September 11, 2001, with the federal program proposed to be established by Title I of H.R. 847, the James Zadroga 9/11 Health and Compensation Act of 2010, as amended and passed by the House of Representatives.
Bisphenol A (BPA) in Plastics and Possible Human Health Effects
This report discusses Bisphenol A (BPA). BPA is used to produce certain types of plastic that are used in thousands of formulations for myriad products. Containers made with these plastics may expose people to small amounts of BPA in food and water. Medical devices and other more ubiquitous products, such as thermal paper coatings, also may contribute significantly to human exposure. Some animal experiments have found that fetal and infant development may be harmed by small amounts of BPA, but scientists disagree about the value of the animal studies for predicting harmful effects in people.
Immigration Policies and Issues on Health-Related Grounds for Exclusion
This report discusses the criteria that foreign nationals must meet before admission to the United States, including the reasons why a foreign national might be denied admission, most particularly on health-related grounds. This report discusses such issues in relation to the recent outbreak of the 2009 H1N1 ("swine flu") virus, and how the outbreak has affected various government agencies, such as the Customs and Border Protection (CBP) agency within the Department of Homeland Security (DHS). This report also discusses efforts to confront and address such issues on a legislative front.
Preventing the Introduction and Spread of Ebola in the United States: Frequently Asked Questions
This report answers common legal and policy questions about the potential introduction and spread of Ebola Virus Disease in the United States.