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Form 1099 Information Reporting Requirements as Modified by the Patient Protection and Affordable Care Act
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.
The Federal Food Safety System: A Primer
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.
Medical Records Privacy: Questions and Answers on the HIPAA Rule
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.
AIDS Funding for Federal Government Programs: FY1981-FY1999
This report provides a synopsis of the budget activity related to AIDS from the discovery of the disease in 1981 through FY1999. Funding for AIDS research, prevention and treatment programs within the Department of Health and Human Services (HHS) discretionary budget has increased from $200,000 in FY1981 to an estimated $3.85 billion in FY1999.
Andean Counterdrug Initiative (ACI) and Related Funding Programs: FY2007 Assistance
This report is about the Andean Counterdrug Initiative (ACI) and related Funding Programs in the fiscal year 2007.
Direct-to-Consumer Advertising of Prescription Drugs
The Direct-to-Consumer advertising of perscription drugs by pharmaceutical companies has been described as any promotional effort with respect to these drugs that targets the general public through the lay media. This report contains information on growth in spending on direct-to-consumer prescription drug advertising, the impact of such advertising, the FDA's existing authority to regulate such advertising, funding, and legislative issues.
Health Insurance: A Primer
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.
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.
Mental Health Parity and the Patient Protection and Affordable Care Act of 2010
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.
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.
Title X (Public Health Service Act) Family Planning Program
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.
Genetic Exceptionalism: Genetic Information and Public Policy
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.
AIDS: The Ryan White CARE Act
This report discusses the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, which makes federal funds available to metropolitan areas and states to assist in health care costs and support services for individuals and families affected by the human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). This report discusses related legislation and appropriations.
Medicare Prescription Drug Benefit: Estimates of Beneficiaries Who Fall Below Countable Income Thresholds, by State
This report provides state-by-state estimates of the percentage and number of beneficiaries who fall below various low-income thresholds, using the definition of income specified in the law.
The Hill-Burton Uncompensated Services Program
This report provides information on the Hospital Survey and Construction Act of 1946, commonly known as the Hill-Burton Act, which was enacted to provide federal financial assistance for the planning, construction, and improvement of health care facilities through grants, loans, and guaranteed loans under Title VI and later Title XVI of the Public Health Service Act. The report also covers the obligations and eligibility requirements for free care, and sources for further information
The Hatch-Waxman Act: A Quarter Century Later
This report provides an overview of the Hatch-Waxman Act a quarter century later.
Genetic Ancestry Testing
From Summary: This report describes genetic ancestry testing, outlines the basic scientific limitations of the testing currently, and provides an overview of the policy issues this testing may raise.
Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”): Current and Proposed Safeguards
This report discusses the then Current and Proposed Safeguards related to Bovine Spongiform Encephalopathy (BSE, or “Mad Cow Disease”) in the United States.
The “Hatch-Waxman” Act: Selected Patent- Related Issues
This report explores several of the major patent-related issues that have been raised in relation to the application of the 1984 Act.
Pandemic Flu and Medical Biodefense Countermeasure Liability Limitation
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.
Military Medical Care Services: Questions and Answers
This report includes questions and answers regarding various military medical care services. What is the purpose of the Military Health Services System, who is eligible to receive this care, and what is the DOD pharmacy benefit are among questions asked and answered in this report.
The Hill-Burton Uncompensated Services Program
This report provides information on the Hospital Survey and Construction Act of 1946, commonly known as the Hill-Burton Act, the obligations and eligibility requirements for free care, and sources for further information.
Health Insurance: A Primer
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.
Mental Health Parity and the Patient Protection and Affordable Care Act of 2010
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.
Addressing Medicare Hospital Readmissions
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.
FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective
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.
Influenza Antiviral Drugs and Patent Law Issues
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.
Influenza Antiviral Drugs and Patent Law Issues
This report identifies and analyzes the patent law aspects of the avian influenza drug situation.
Walter Reed Army Medical Center: Realignment Under BRAC 2005 and Options for Congress
This report details the BRAC Commission recommendation to create the WRNMMC, and the concomitant realignment of the WRAMC. It describes the concerns raised by the community before the BRAC Commission regarding the closure of the WRAMC main post and explains each of the 13 parts of the overall recommendation.
Medicaid Prescription Drug Pricing and Policy
This report provides an overview of the Medicaid prescription drug pricing and policy.
Legal Issues Related to Prescription Drug Sales on the Internet
This report provides a legal analysis of issues related to prescription drug sales on the Internet, including issues involving online pharmacies and physicians who prescribe medications over the Internet. This report also provides an overview of the various federal and state laws that regulate this field, including laws and regulations covering prescription drugs, controlled substances, doctors, and pharmacies.
Immigration: Foreign Physicians and the J-1 Visa Waiver Program
Report on the Educational and Cultural Exchange Visitor program and how it has been used for foreign medical graduates to enter the United States.
Importing Prescription Drugs — Comparison of the Drug Import Provisions in the Medicare Reform Bills, H.R. 2427, and Current Law
This report discusses the debate to permit the importation of FDA-approved drugs from less expensive foreign sources as the prices of prescription drugs has risen, considering issues such as cost, safety, policy, consumer protections, and international ramifications.
Military Medical Care: Questions and Answers
This report answers several frequently-asked questions about military health care, particularly related to TRICARE and its various aspects.
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.
The 2009 Influenza A(H1N1) "Swine Flu" Outbreak: U.S. Responses to Global Human Cases
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.
Former NFL Players: Disabilities, Benefits, and Related Issues
This report discusses professional football players' injuries and health conditions that might have long-term consequences for their health.
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).
Public Health and Medical Preparedness and Response: Issues in the 111th Congress
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.
Federal R&D, Drug Discovery, and Pricing: Insights from the NIH-University-Industry Relationship
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.
The 2009 H1N1 "Swine Flu" Outbreak: An Overview
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.
The 2009 Influenza A (H1N1) "Swine Flu" Outbreak: An Overview
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.
End-of-Life Care: Services, Costs, Ethics, and Quality of Care
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.
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.
Stem Cell Research: Ethical Issues
This report discusses the ethical arguments that surround human embryonic stem cell research (ESR). Human stem cell research is controversial not because of its goals, but rather because of the means of obtaining some of the cells.
Military Medical Care: Questions and Answers
This report attempts to answer basic questions about defense health care, its beneficiary population, the medical services it provides, its costs, and major changes that are underway or have been proposed.
Federal Taxation of the Drug Industry and Its Effects on New Drug Development
This report examines the impact of federal taxation on the incentive to invest in new drug development. More specifically, it looks at the provisions in current tax law that affect the performance of the drug industry, compares the industry's federal tax burden with that of other major industries, and assesses the effect of federal taxation on the incentive to invest in new drug development.
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.
Direct-to-Consumer Advertising of Prescription Drugs
This report describes the current status of direct-to-consumer (DTC) drug advertising; analyzes issues surrounding it; and discusses potential options for Congress.
The U.S. Mental Health Delivery System Infrastructure: A Primer
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.
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