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Military Medical Care: Frequently Asked Questions

Description: 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 H… more
Date: November 8, 2018
Creator: Mendez, Bryce H. P.
Partner: UNT Libraries Government Documents Department
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Biologics and Biosimilars: Background and Key Issues

Description: 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.
Date: October 27, 2017
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
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Telehealth Services Proposed for Medicare Part B Reimbursements, 2018: Fact Sheet

Description: 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.
Date: November 15, 2017
Creator: Elliott, Victoria L.
Partner: UNT Libraries Government Documents Department
open access

Frequently Asked Questions About Prescription Drug Pricing and Policy

Description: 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 congre… more
Date: May 2, 2017
Creator: Kirchhoff, Suzanne M.; Johnson, Judith A. & Thaul, Susan
Partner: UNT Libraries Government Documents Department
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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
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FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development

Description: 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.
Date: April 11, 2017
Creator: Dabrowska, Agata
Partner: UNT Libraries Government Documents Department
open access

The Federal Food Safety System: A Primer

Description: 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.
Date: December 16, 2016
Creator: Johnson, Renée
Partner: UNT Libraries Government Documents Department
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Orlando Shooting Revives Debate over Restricting Blood Donations by Gay Men

Description: 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.
Date: August 1, 2016
Creator: Redhead, C. S.
Partner: UNT Libraries Government Documents Department
open access

The FDA Medical Device User Fee Program: MDUFA IV Reauthorization

Description: 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.
Date: June 6, 2016
Creator: Johnson, Judith A.
Partner: UNT Libraries Government Documents Department
open access

Title X (Public Health Service Act) Family Planning Program

Description: 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.
Date: March 15, 2016
Creator: Napili, Angela
Partner: UNT Libraries Government Documents Department
open access

Health Care for Veterans: Suicide Prevention

Description: 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.
Date: February 23, 2016
Creator: Bagalman, Erin
Partner: UNT Libraries Government Documents Department
open access

The Veterans Health Administration and Medical Education: A Fact Sheet

Description: 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.
Date: January 19, 2016
Creator: Heisler, Elayne J. & Panangala, Sidath V.
Partner: UNT Libraries Government Documents Department
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Form 1099 Information Reporting Requirements as Modified by the Patient Protection and Affordable Care Act

Description: 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.
Date: August 6, 2010
Creator: Pettit, Carol A. & Liu, Edward C.
Partner: UNT Libraries Government Documents Department
open access

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-… more
Date: March 27, 2014
Creator: Sarata, Amanda K.
Partner: UNT Libraries Government Documents Department
open access

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
open access

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,… more
Date: October 31, 2013
Creator: Thaul, Susan
Partner: UNT Libraries Government Documents Department
open access

Title X (Public Health Service Act) Family Planning Program

Description: 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.
Date: March 25, 2011
Creator: Napili, Angela
Partner: UNT Libraries Government Documents Department
open access

The Hatch-Waxman Act: A Quarter Century Later

Description: This report provides an overview of the Hatch-Waxman Act a quarter century later.
Date: March 13, 2012
Creator: Schacht, Wendy H. & Thomas, John R.
Partner: UNT Libraries Government Documents Department
open access

Health Insurance: A Primer

Description: 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.
Date: January 11, 2011
Creator: Bernadette, Fernandez
Partner: UNT Libraries Government Documents Department
open access

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
open access

Addressing Medicare Hospital Readmissions

Description: 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.
Date: May 25, 2012
Creator: Tilson, Sibyl
Partner: UNT Libraries Government Documents Department
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Medicaid Prescription Drug Pricing and Policy

Description: This report provides an overview of the Medicaid prescription drug pricing and policy.
Date: November 7, 2014
Creator: Binder, Cliff
Partner: UNT Libraries Government Documents Department
open access

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
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