Congressional Research Service Reports - 537 Matching Results

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Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests

Description: 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.
Date: March 27, 2014
Creator: Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department

Mental Health Parity and the Patient Protection and Affordable Care Act of 2010

Description: 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.
Date: December 28, 2011
Creator: Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department

Mental Health Parity and the Patient Protection and Affordable Care Act of 2010

Description: 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.
Date: January 7, 2011
Creator: Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department

Pharmaceutical Supply Chain Security

Description: 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.
Date: October 31, 2013
Creator: Thaul, Susan
Partner: UNT Libraries Government Documents Department

Patient Safety: Legislation to Promote Voluntary Reporting of Medical Errors

Description: 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.
Date: November 26, 2003
Creator: Redhead, C. S.
Partner: UNT Libraries Government Documents Department

The Federal Food Safety System: A Primer

Description: 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.
Date: February 7, 2007
Creator: Becker, Geoffrey S. & Porter, Donna V.
Partner: UNT Libraries Government Documents Department

Genetic Exceptionalism: Genetic Information and Public Policy

Description: 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.
Date: February 14, 2008
Creator: Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department

Medical Records Privacy: Questions and Answers on the HIPAA Rule

Description: 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.
Date: February 4, 2005
Creator: Redhead, C. S.
Partner: UNT Libraries Government Documents Department

Influenza Antiviral Drugs and Patent Law Issues

Description: 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.
Date: August 16, 2007
Creator: Yeh, Brian T.
Partner: UNT Libraries Government Documents Department

Military Health Care: The Issue of “Promised” Benefits

Description: 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.
Date: February 10, 2000
Creator: Burrelli, David F.
Partner: UNT Libraries Government Documents Department

The 2009 Influenza A(H1N1) "Swine Flu" Outbreak: U.S. Responses to Global Human Cases

Description: 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.
Date: May 26, 2008
Creator: Salaam-Blyther, Tiaji
Partner: UNT Libraries Government Documents Department

The Ryan White HIV/AIDS Program: Overview and Impact of the Affordable Care Act

Description: 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.
Date: December 21, 2015
Creator: Johnson, Judith A. & Heisler, Elayne J.
Partner: UNT Libraries Government Documents Department

Military Medical Care: Questions and Answers

Description: 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).
Date: August 4, 2008
Creator: Best, Richard A., Jr.
Partner: UNT Libraries Government Documents Department

The 2009 H1N1 "Swine Flu" Outbreak: An Overview

Description: 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.
Date: April 30, 2009
Creator: Lister, Sarah A. & Redhead, C. S.
Partner: UNT Libraries Government Documents Department

The 2009 Influenza A (H1N1) "Swine Flu" Outbreak: An Overview

Description: 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.
Date: May 5, 2009
Creator: Lister, Sarah A. & Redhead, C. S.
Partner: UNT Libraries Government Documents Department

Federal R&D, Drug Discovery, and Pricing: Insights from the NIH-University-Industry Relationship

Description: 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.
Date: February 3, 2009
Creator: Schacht, Wendy H.
Partner: UNT Libraries Government Documents Department

Public Health and Medical Preparedness and Response: Issues in the 111th Congress

Description: 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.
Date: February 10, 2009
Creator: Lister, Sarah A.
Partner: UNT Libraries Government Documents Department

End-of-Life Care: Services, Costs, Ethics, and Quality of Care

Description: 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.
Date: February 23, 2009
Creator: Colello, Kirsten J.; Mulvey, Janemarie; Sarata, Amanda K.; Williams, Erin D. & Thomas, Kenneth R.
Partner: UNT Libraries Government Documents Department

Military Medical Care: Questions and Answers

Description: 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.
Date: May 20, 2008
Creator: Best, Richard A., Jr.
Partner: UNT Libraries Government Documents Department

FDA Regulation of Follow-On Biologics

Description: 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.
Date: February 24, 2009
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department

The U.S. Mental Health Delivery System Infrastructure: A Primer

Description: 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.
Date: April 21, 2009
Creator: Sundararaman, Ramya
Partner: UNT Libraries Government Documents Department