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Military Medical Care: Frequently Asked Questions
This report answers selected frequently-asked questions about military health care, including: 1) How is the Military Health System structured?, 2) What is TRICARE?, 3) What are the different TRICARE plans and who is eligible?, 4) What are the costs of military health care to beneficiaries?, 5) What is the relationship of TRICARE to Medicare?, 6) How does the Affordable Care Act affect TRICARE?, 7) When can beneficiaries change their TRICARE plan?, and 8) What is the Medicare Eligible Retiree Health Care fund, which funds TRICARE for Life?
Biologics and Biosimilars: Background and Key Issues
This report discusses biologic and biosimilar medicines and their production and approval by the FDA. Recent legislation regarding FDA approval regulations and federal research and drug development are also discussed.
Telehealth Services Proposed for Medicare Part B Reimbursements, 2018: Fact Sheet
This report discusses telehealth services covered under Medicare and describes the five conditions that a telehealth service must meet to be covered and paid for under Medicare Part B, provides an overview of how the Secretary of the Department of Health and Human Services (HHS) adds telehealth services to Medicare's reimbursable list, and includes a table listing the proposed telehealth services to be added to the CY2018 list for Medicare reimbursement.
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).
CRISPR Gene Editing Research in Embryos Generates Scientific and Ethics Debate
This report discusses the results of a recent experiment on the use of gene modification for decreasing the chance of children having hypertrophic cardiomyopathy which was done through the use of CRISPR to modify the genes of human embryos at a private facility. Restrictions on the use of public funds for such studies, a brief explanation of the science, and ethical concerns are discussed.
FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development
This report provides a brief history of FDA drug regulation, describes FDA's early risk management programs, and focuses on the agency's current risk management authorities, specifically risk evaluation and mitigation strategies (REMS). The report also discusses issues that have arisen as a result of REMS, particularly the impact on generic drug competition. It does not discuss antitrust issues raised by restricted distribution systems.
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.
Orlando Shooting Revives Debate over Restricting Blood Donations by Gay Men
This report discusses new FDA guidance regarding blood donations from sexually-active gay men. Since the 1980s, the Food and Drug Administration (FDA) has recommended that men who have sex with men (MSM) be indefinitely deferred (i.e., permanently banned) from donating blood. This action was taken to help control the spread of the human immunodeficiency virus (HIV) through the blood supply.
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.
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.
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.
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.
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.
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.
The Hatch-Waxman Act: A Quarter Century Later
This report provides an overview of the Hatch-Waxman Act a quarter century later.
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.
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.
Addressing Medicare Hospital Readmissions
This report highlights the issue of one-fifth of medicare patients in 2005 being readmitted to a hospital within thirty days time. These readmissions put a strain on the budget, the majority of which it is estimated may be avoidable. The report notes that Medicare as a program is working on moving around those difficulties, without reducing the quality of care.
Medicaid Prescription Drug Pricing and Policy
This report provides an overview of the Medicaid prescription drug pricing and policy.
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.
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.
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.
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.
"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. Under this policy, but not the law, service members are not to be asked about nor allowed to discuss their "same-sex orientation." This report also describes recent efforts by certain Members of Congress to amending this policy.
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.
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.
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. The World Trade Center (WTC) Medical Monitoring and Treatment Program (MMTP) and the World Trade Center Health Program (WTCHP) are the specific programs compared in this report.
TRICARE and VA Health Care: Impact of the Patient Protection and Affordable Care Act (PPACA)
The 111th Congress passed, and the President signed into law, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, and hereafter referred to as PPACA. This report addresses key questions concerning how PPACA affects the Department of Defense (DOD) TRICARE program and Department of Veterans Affairs (VA) health care.
TRICARE and VA Health Care: Impact of the Patient Protection and Affordable Care Act (PPACA)
The 111th Congress passed, and the President signed into law, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, and hereafter referred to as PPACA. This report addresses key questions concerning how PPACA affects the Department of Defense (DOD) TRICARE program and Department of Veterans Affairs (VA) health care.
Centers for Disease Control and Prevention Global Health Programs: FY2001-FY2011
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 has changed during this period.
The Measles: Background and Federal Role in Vaccine Policy
This report presents basic information about measles, its history in the United States, available treatments to prevent individuals from contracting measles, and the federal role in combating measles--from funding, to research, to the authority of the federal government in requiring mandatory childhood vaccinations.
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.
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.
Hospital-Based Emergency Departments: Background and Policy Considerations
This report describes Emergency departments (EDs), the role they play in the health care delivery system, and current federal involvement in supporting EDs. It then discusses the causes and consequences of three commonly identified and interrelated challenges that EDs face: (1) crowding, (2) providing repeat care to a subset of patients who are frequent users, and (3) providing care to a large population who have behavioral health conditions when an ED lacks the appropriate resources to provide such treatment. The report concludes with policy options that Congress may consider to potentially improve ED functioning and reduce payer costs.
U.S. and International Health Responses to the Ebola Outbreak in West Africa
In March 2014, an Ebola Virus Disease (EVD) outbreak was reported in Guinea, West Africa. The outbreak is the first in West Africa and has caused an unprecedented number of cases and deaths. The outbreak is continuing to spread in Guinea, Sierra Leone, and Liberia (the "affected countries"); it has been contained in Nigeria and Senegal, and has been detected in Mali. As of October 22, 2014, more than 10,000 people have contracted EVD, more than half of whom have died. This report focuses on the health impacts of the outbreak and discusses U.S. and international responses to those health challenges.
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.
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.
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.
"Don't Ask, Don't Tell": Military Policy and the Law 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. Under this policy, but not the law, service members are not to be asked about nor allowed to discuss their "same-sex orientation." This report also describes recent efforts by certain Members of Congress to amending this policy.
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 Affairs: Presumptive Service Connection and Disability Compensation
This report discusses presumptive service connection, its legislative history, and current challenges in making evidence-based determinations of presumptions. It also discusses the Agent Orange Act (P.L. 102-4) and suggests implications of the process established by the act for future presumptive service-connected determinations.
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.
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.
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. The World Trade Center (WTC) Medical Monitoring and Treatment Program (MMTP) and the World Trade Center Health Program (WTCHP) are the specific programs compared in this report.
Title X (Public Health Service Act) Family Planning Program
This report discusses the Family Planning Program, Title X of the Public Health Service Act (42 U.S.C. §§300 to 300a-6), which is the only domestic federal program devoted solely to family planning and related preventive health services. The report discusses various services related to Title X and also considers current legislation related to the program.
The 2014 Ebola Outbreak: International and U.S. Responses
This report discusses the Ebola virus disease (Ebola or EVD), which is a severe, often fatal disease that was first detected near the Ebola River in the Democratic Republic of the Congo (DRC) in 1976.
International Family Planning Programs: Issues for Congress
This report looks at how the debate over family planning within the U.S. is spilling over to U.S.-funded family planning programs abroad.
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