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Treating Ebola Patients in the United States: Health Care Delivery Implications

Description: This report discusses the recent response to Ebola patients in the United States. While the U.S. health care system has the resources to effectively identify and treat Ebola cases, a situation that is novel, emergent, and resource-intensive may test the system's ability to effectively mobilize those resources.
Date: November 4, 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

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

Genetic Testing: Scientific Background for Policymakers

Description: This report discusses bills addressing genetic discrimination in health insurance and employment; personalized medicine; the patenting of genetic material; and the oversight of clinical laboratory tests (in vitro diagnostics), including genetic tests.
Date: February 20, 2014
Creator: Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department

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: December 17, 2014
Creator: Sarata, Amanda K. & Johnson, Judith A.
Partner: UNT Libraries Government Documents Department

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

FDA Authorization Act of 2017 (FDARA, P.L. 115-52)

Description: This report presents an overview of the Food and Drug Administration Reauthorization Act (FDARA) of 2017 by title and section, providing a narrative context for each title, as well as a brief description of each section.
Date: September 21, 2017
Creator: Sarata, Amanda K.; Dabrowska, Agata; Johnson, Judith A. & Thaul, Susan
Partner: UNT Libraries Government Documents Department

CRISPR Gene Editing Research in Embryos Generates Scientific and Ethics Debate

Description: 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.
Date: September 12, 2017
Creator: Sargent, John F., Jr.; Sarata, Amanda K. & Johnson, Judith A.
Partner: UNT Libraries Government Documents Department

FDA Human Medical Product User Fee Programs: In Brief

Description: This report discusses FDA human medical product user fees for prescription drugs, medical devices, generic drugs, and biosimilars which are charged to companies producing the products and make up a large portion of the FDA's revenues. User fees are authorized in legislation on a five-year cycle, with authority for their actual collection and expenditure provided each year through the annual appropriations process. Appendix A outlines various features of the user fee programs.
Date: November 21, 2017
Creator: Dabrowska, Agata; Johnson, Judith A.; Sarata, Amanda K. & Thaul, Susan
Partner: UNT Libraries Government Documents Department

Discretionary Spending Under the Affordable Care Act (ACA)

Description: The Patient Protection and Affordable Care Act (Affordable Care Act, or ACA) reauthorized funding for numerous existing discretionary grant programs administered by the Department of Health and Human Services (HHS). The ACA also created many new discretionary grant programs and provided for each an authorization of appropriations. Generally, the law authorized (or reauthorized) appropriations through FY2014 or FY2015. This report summarizes all the discretionary spending provisions in the ACA.
Date: October 28, 2014
Creator: Redhead, C. Stephen; Colello, Kirsten J.; Heisler, Elayne J.; Lister, Sarah A. & Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department

Discretionary Spending Under the Affordable Care Act (ACA)

Description: This report examines the Affordable Care Act's (ACA's) effects on discretionary spending. It first discusses all the ACA authorizations (and reauthorizations) of appropriations for grant and other programs; this information, along with actual funding amounts, is summarized in a series of tables. The report then reviews the ACA administrative costs borne by CMS and the IRS.
Date: January 13, 2016
Creator: Redhead, C. Stephen; Colello, Kirsten J.; Heisler, Elayne J.; Lister, Sarah A. & Sarata, Amanda K.
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

Discretionary Spending Under the Affordable Care Act (ACA)

Description: This report examines the Affordable Care Act's (ACA's) effects on discretionary spending. It first discusses all the ACA authorizations (and reauthorizations) of appropriations for grant and other programs; this information, along with actual funding amounts, is summarized in a series of tables. The report then reviews the ACA administrative costs borne by CMS and the IRS.
Date: February 8, 2017
Creator: Redhead, C. Stephen; Colello, Kirsten J.; Heisler, Elayne J.; Lister, Sarah A. & Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department

Comparison of the Bills to Extend State Children's Health Insurance Program (CHIP) Funding

Description: This report discuses recently proposed bills in the Senate (KIDS Act) and the House (HEALTHY KIDS Act) to extend funding for the State Children's Health Insurance Program (CHIP) which is currently unfunded for the 2018 fiscal year and running off of unused funds in each state from previous years. On October 4, 2017, both the Senate Finance Committee and the House Energy and Commerce Committee had markups on different bills that would extend CHIP federal funding through FY2022, among other provisions.
Date: October 23, 2017
Creator: Mitchell, Alison; Baumrucker, Evelyne P.; Dabrowska, Agata; Davis, Patricia A.; Gopalan, Susannah V. & Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department

Advanced Gene Editing: CRISPR-Cas9

Description: This report describes a new gene editing technology, known as CRISPR-Cas9, with the potential to revolutionize genetic engineering and the biotechnology industry. The report then provides information on the potential economic benefits of the technology and identifies some issues for congressional consideration, including the regulation of current and future products, national security concerns, and ethical and societal issues surrounding the use of the technology.
Date: April 28, 2017
Creator: Gallo, Marcy E.; Sargent, John F., Jr.; Sarata, Amanda K. & Cowan, Tadlock
Partner: UNT Libraries Government Documents Department

Comparison of the Bills to Extend State Children's Health Insurance Program (CHIP) Funding

Description: This report discusses bills and their provisions related to extending funding for the State Children's Health Insurance Program (CHIP) whose funding expired at the end of the 2017 fiscal year. The House passed the CHAMPIONING HEALTHY KIDS Act on November 3, 2017, by a vote of 242 to 174. This report contains a table that provides an overview of the provisions in the KIDS Act and Division B of the CHAMPIONING HEALTHY KIDS Act as baselined against current law. The section following the table provides more detailed summaries of the provisions in the KIDS Act and Division B of the CHAMPIONING HEALTHY KIDS Act
Date: November 3, 2017
Creator: Mitchell, Allison; Baumrucker, Evelyne P.; Dabrowska, Agata; Davis, Patricia A.; Gopalan, Susannah V. & Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department

Public Health Service Agencies: Overview and Funding (FY2015-FY2017)

Description: This report gives a brief overview of the eight agencies within the Department of Health and Human Services (HHS) which are designated components of the U.S. Public Health Services (PHS), and summarizes its funding for FY2015 through FY2017.
Date: May 19, 2016
Creator: Redhead, C. S.; Dabrowska, Agata; Bagalman, Erin; Heisler, Elayne J.; Johnson, Judith A.; Lister, Sarah A. et al.
Partner: UNT Libraries Government Documents Department

The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)

Description: 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.
Date: August 21, 2012
Creator: Thaul, Susan; Bagalman, Erin; Corby-Edwards, Amalia K.; Glassgold, Judith M.; Johnson, Judith A.; Lister, Sarah A. et al.
Partner: UNT Libraries Government Documents Department

Public Health Service Agencies: Overview and Funding (Fiscal Year 2016-Fiscal Year 2018)

Description: This report outlines the funding types received by U.S. Public Health Service agencies and provides brief overviews of each agency and their recent funding trends. The eight agencies discussed are the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), the Agency for Toxic Substances and and Disease Registry (ATSDR), the Food and Drug Administration (FDA), the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS), the National Institutes of Health (NIH), and the Substance Abuse and Mental Health Services Administration (SAMHSA).
Date: August 16, 2017
Creator: Redhead, C. Stephen; Dabrowska, Agata; Bagalman, Erin; Heisler, Elayne J.; Johnson, Judith A.; Lister, Sarah A. et al.
Partner: UNT Libraries Government Documents Department