Search Results

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?
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
Medicaid Prescription Drug Pricing and Policy
This report provides an overview of the Medicaid prescription drug pricing and policy.
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.
Title X (Public Health Service Act) Family Planning Program
This report looks at several bills addressing the Family Planning Program (Title X of the Public Health Service Act) which have been introduced in the 112th Congress, including: funding for abortion-providing entities, elimination of the program, and prohibitions on government spending for 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.
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, specifically examining the health-related grounds for exclusion. It provides this information in the context of recent outbreaks of communicable diseases abroad such as Ebola in West Africa, avian influenza in China, polio in the middle east, and dengue fever in the Caribbean.
Ebola: 2014 Outbreak in West Africa
This report gives a overview of the West African Ebola outbreak that began in March, 2014. The report discusses the nature of the disease as well as local and international responses to it. The report also briefly examines U.S policy and congressional actions in the wake of the outbreak.
Safe at Home? Letting Ebola-Stricken Americans Return
This report examines the U.S. practice of isolation and quarantine for citizens arriving in the country who have been infected with or exposed to a dangerous communicable disease. The report frames this information in the context of the two American healthcare workers who were brought back into the U.S. for treatment after contracting the Ebola virus in West Africa in the Summer of 2014.
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.
Mandatory Vaccinations: Precedent and Current Laws
This report provides an overview of the legal precedent for mandatory vaccination laws, and of state laws that require certain individuals or populations, including school-aged children and health care workers, to be vaccinated against various communicable diseases. Also discussed are state laws providing for mandatory vaccinations during a public health emergency or outbreak of a communicable disease.
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.
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.
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 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.
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.
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.
Military Medical Care: Questions and Answers
Report that 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.
Prevalence of Mental Illness in the United States: Data Sources and Estimates
This report briefly describes the methodology and selected findings of three large federally funded surveys that provide national prevalence estimates of diagnosable mental illness: the National Comorbidity Survey Replication (NCS-R), the National Comorbidity Survey Replication Adolescent Supplement (NCS-A), and the National Survey on Drug Use and Health (NSDUH). This report presents prevalence estimates of any mental illness and serious mental illness based on each survey and ends with a brief discussion of how these prevalence estimates might inform policy discussions.
Federal Authority to Regulate the Compounding of Human Drugs
This report will examine the FDA's regulation of drug compounding and will discuss relevant legal authorities. The report will conclude by discussing potential limits to the FDA's authority to regulate human drug compounding.
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.
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.
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.
Progress in Combating Neglected Tropical Diseases (NTDs): U.S. and Global Efforts from FY2006 to FY2013
This report discusses the prevalence of "neglected tropical diseases" (NTDs), U.S. and global actions to address them, and options the 113th Congress might consider.
Suicide Prevention Efforts of the Veterans Health Administration
This report discusses seven areas of Veterans Health Administration (VHA) suicide prevention interventions: easy access to care, education, screening and treatment, limited access to lethal means, suicide hotline, media restrictions, and suicide prevention coordinators.
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.
Mayo v. Prometheus: Implications for Patents, Biotechnology, and Personalized Medicine
Report that reviews the Supreme Court's 2012 Mayo Collaborative Services v. Prometheus Laboratories decision (wherein the court held that a patent claiming a method of optimizing therapies for autoimmune disease was invalid) and briefly consider its implications for innovation and public health.
The President's Emergency Plan for AIDS Relief (PEPFAR): Funding Issues After a Decade of Implementation, FY2004-FY2013
This report outlines U.S. spending on global HIV/AIDS programs since the inception of the President's Emergency Plan for AIDS Relief (PEPFAR), analyzes global HIV/AIDS funding by other donors, and highlights key issues pertaining to funding that will face the 113th Congress as it considers the future of PEPFAR
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.
Title X (Public Health Service Act) Family Planning Program
This report looks at several bills addressing the Family Planning Program (Title X of the Public Health Service Act) which have been introduced in the 112th Congress, including: funding for abortion-providing entities, elimination of the program, and prohibitions on government spending for the program.
The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)
This report provides a brief policy background narrative and an overview of provisions for each title of the Food and Drug Administration Safety and Innovation Act (FDASIA), P.L. 112-144. The legislation amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities.
Back to Top of Screen