Congressional Research Service Reports - 542 Matching Results

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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

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

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 congressional hearings and documents (see Appendix A) and a directory of CRS prescription drug experts (see Appendix B).
Date: May 2, 2017
Creator: Kirchhoff, Suzanne M.; 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 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

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

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

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

Background and Legal Issues Related to Stem Cell Research

Description: This report discusses issues regarding stem cell research. With certain restrictions, the President has announced that federal funds may be used to conduct research on human embryonic stem cells. Federal research is limited to "the more than 60" existing stem cell lines that were derived (1) with the informed consent of the donors; (2) from excess embryos created solely for reproductive purposes; and (3) without any financial inducements to the donors. No federal funds will be used for the derivation or use of stem cell lines derived from newly destroyed embryos; the creation of any human embryos for research purposes; or cloning of human embryos for any purposes.
Date: October 26, 2004
Creator: Shimabukuro, Jon O.
Partner: UNT Libraries Government Documents Department

Stem Cell Research

Description: This report provides background on the research and potential applications of research that uses embryonic and adult stem cells. It also provides information about the current federal and state regulatory landscape, related Congressional and international actions, and relevant ethical concerns.
Date: December 13, 2004
Creator: Johnson, Judith A. & Williams, Erin
Partner: UNT Libraries Government Documents Department

Overview of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

Description: This report examines the the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which creates a prescription drug benefit for Medicare beneficiaries and establishes a new Medicare Advantage program to replace the current Medicare+Choice program.
Date: December 6, 2004
Creator: O'Sullivan, Jennifer; Chaikind, Hinda; Tilson, Sibyl; Boulanger, Jennifer & Morgan, Paulette
Partner: UNT Libraries Government Documents Department

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

Pandemic Flu and Medical Biodefense Countermeasure Liability Limitation

Description: 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.
Date: December 5, 2006
Creator: Cohen, Henry
Partner: UNT Libraries Government Documents Department

Medicare Prescription Drug Proposals: Estimates of Aged Beneficiaries Who Fall Below Income Criteria, by State

Description: This report discusses bills related to Medicare benefits, which include additional assistance for low-income beneficiaries. The assistance would have been in the form of reduced, subsidized or eliminated premiums, deductibles and other cost-sharing. Proposals in the 108th Congress will probably also include some of these features for low-income beneficiaries.
Date: February 11, 2003
Creator: Peterson, Chris L. & Morgan, Paulette C.
Partner: UNT Libraries Government Documents Department

U.S. and International Responses to the Global Spread of Avian Flu: Issues for Congress

Description: This report will provide an account of global H5N1-related human infections and deaths, outline U.S. government and international responses to the global spread of H5N1, discuss situations in various countries affected by H5N1, and present some foreign policy issues for Congress.
Date: February 6, 2006
Creator: Salaam-Blyther, Tiaji & Chanlett-Avery, Emma
Partner: UNT Libraries Government Documents Department

Veterans' Health Care Issues in the 109th Congress

Description: This report provides an overview of major issues facing veterans' health care during the 109th Congress. The report's primary focus is on veterans and not military retirees.
Date: June 27, 2005
Creator: Panangala, Sidath V.
Partner: UNT Libraries Government Documents Department

Stem Cell Research

Description: This report provides background on the research and potential applications of research that uses embryonic and adult stem cells. It also provides information about the current federal and state regulatory landscape, related Congressional and international actions, and relevant ethical concerns.
Date: August 13, 2004
Creator: Johnson, Judith A. & Williams, Erin
Partner: UNT Libraries Government Documents Department

Medical Malpractice Liability Reform: H.R. 5, 109th Congress

Description: This report discusses H.R. 5, which would preempt state law regarding some aspects of medical malpractice liability and liability for defective medical products, including drugs. The legislation would among other things, place caps on noneconomic and punitive damages (in states that have not enacted and do not enact caps), eliminate joint and several liability, modify the collateral source rule, limit lawyers' contingent fees, enact a federal statute of limitations, and provide for periodic payment of future damages.
Date: January 18, 2006
Creator: Cohen, Henry
Partner: UNT Libraries Government Documents Department

Human Cloning

Description: This report discusses human cloning science and federal policy regarding human embryo research. It provides background on the topic, federal policies, state laws, Congressional actions, and ethical issues.
Date: July 20, 2006
Creator: Johnson, Judith A. & Williams, Erin D.
Partner: UNT Libraries Government Documents Department

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

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

Military Medical Care Services: Questions and Answers

Description: This report attempts to answer basic questions about the Military Health Services System (MHSS), its beneficiary population, the medical services it provides, its costs, and major changes that are underway or have been proposed. Citations are made to more detailed CRS studies where appropriate.
Date: January 26, 2005
Creator: Best, Richard A., Jr.
Partner: UNT Libraries Government Documents Department

Smallpox Vaccine Injury Compensation

Description: This report discusses the Public Safety Officers’ Benefits Program, which provides for compensation of individuals injured by vaccinations given as part of a countermeasure plan declared by the Secretary of Health and Human Services in preparation for potential hostile activities involving the smallpox virus.
Date: June 13, 2003
Creator: Thaul, Susan
Partner: UNT Libraries Government Documents Department

FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

Description: The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs—the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003—and enacted a new law addressing devices—the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps.
Date: December 2, 2008
Creator: Thaul, Susan
Partner: UNT Libraries Government Documents Department