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 Collection: Congressional Research Service Reports
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. digital.library.unt.edu/ark:/67531/metadc855900/
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. digital.library.unt.edu/ark:/67531/metadc855943/
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. digital.library.unt.edu/ark:/67531/metadc855947/
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. digital.library.unt.edu/ark:/67531/metadc855798/
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. digital.library.unt.edu/ark:/67531/metadc847556/
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. digital.library.unt.edu/ark:/67531/metadc847748/
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. digital.library.unt.edu/ark:/67531/metadc847645/
U.S. and International Responses to the Global Spread of Avian Flu: Issues for Congress
This report will provide an account of global H5N1-related human infections and deaths, outline U.S. government and international responses to the global spread of H5N1, discuss situations in various countries affected by H5N1, and present some foreign policy issues for Congress. digital.library.unt.edu/ark:/67531/metadc847619/
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. digital.library.unt.edu/ark:/67531/metadc847509/
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. digital.library.unt.edu/ark:/67531/metadc824749/
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. digital.library.unt.edu/ark:/67531/metadc824701/
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. digital.library.unt.edu/ark:/67531/metadc824519/
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. digital.library.unt.edu/ark:/67531/metadc824415/
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. digital.library.unt.edu/ark:/67531/metadc824418/
Military Medical Care Services: Questions and Answers
This report attempts to answer basic questions about the Military Health Services System (MHSS), its beneficiary population, the medical services it provides, its costs, and major changes that are underway or have been proposed. Citations are made to more detailed CRS studies where appropriate. digital.library.unt.edu/ark:/67531/metadc824459/
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. digital.library.unt.edu/ark:/67531/metadc821670/
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. digital.library.unt.edu/ark:/67531/metadc822635/
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. digital.library.unt.edu/ark:/67531/metadc810015/
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. digital.library.unt.edu/ark:/67531/metadc822647/
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. digital.library.unt.edu/ark:/67531/metadc822659/
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. digital.library.unt.edu/ark:/67531/metadc821116/
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. digital.library.unt.edu/ark:/67531/metadc821977/
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. digital.library.unt.edu/ark:/67531/metadc822719/
FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective
The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs—the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003—and enacted a new law addressing devices—the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps. digital.library.unt.edu/ark:/67531/metadc822699/
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. digital.library.unt.edu/ark:/67531/metadc821479/
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. digital.library.unt.edu/ark:/67531/metadc821477/
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. digital.library.unt.edu/ark:/67531/metadc821455/
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. digital.library.unt.edu/ark:/67531/metadc822432/
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. digital.library.unt.edu/ark:/67531/metadc821510/
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. digital.library.unt.edu/ark:/67531/metadc795652/
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. digital.library.unt.edu/ark:/67531/metadc795645/
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. digital.library.unt.edu/ark:/67531/metadc795903/
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. digital.library.unt.edu/ark:/67531/metadc770530/
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). digital.library.unt.edu/ark:/67531/metadc770600/
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. digital.library.unt.edu/ark:/67531/metadc743456/
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. digital.library.unt.edu/ark:/67531/metadc743493/
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. digital.library.unt.edu/ark:/67531/metadc743611/
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. digital.library.unt.edu/ark:/67531/metadc743554/
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. digital.library.unt.edu/ark:/67531/metadc743362/
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. digital.library.unt.edu/ark:/67531/metadc700567/
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. digital.library.unt.edu/ark:/67531/metadc700547/
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. digital.library.unt.edu/ark:/67531/metadc700846/
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. digital.library.unt.edu/ark:/67531/metadc700825/
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. digital.library.unt.edu/ark:/67531/metadc700845/
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. digital.library.unt.edu/ark:/67531/metadc700847/
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. digital.library.unt.edu/ark:/67531/metadc700865/
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. digital.library.unt.edu/ark:/67531/metadc700863/
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. digital.library.unt.edu/ark:/67531/metadc700831/
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. digital.library.unt.edu/ark:/67531/metadc700574/
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. digital.library.unt.edu/ark:/67531/metadc700837/
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