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Extending Medicare Reimbursement In Clinical Trials
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Book Synopsis Extending Medicare Reimbursement in Clinical Trials by : Institute of Medicine
Download or read book Extending Medicare Reimbursement in Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2000-02-17 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt: Increasingly over the past five years, uncertainty about reimbursement for routine patient care has been suspected as contributing to problems enrolling people in clinical trials. Clinical trial investigators cannot guarantee that Medicare will pay for the care required, and they must disclose this uncertainty to potential participants during the informed consent process. Since Medicare does not routinely "preauthorize" care (as do many commercial insurers) the uncertainty cannot be dispelled in advance. Thus, patients considering whether to enter trials must assume that they may have to pay bills that Medicare rejects simply because they have enrolled in the trial. This report recommends an explicit policy for reimbursement of routine patient care costs in clinical trials. It further recommends that HCFA provide additional support for selected clinical trials, and that the government support the establishment of a national clinical trials registry. These policies (1) should assure that beneficiaries would not be denied coverage merely because they have volunteered to participate in a clinical trial; and (2) would not impose excessive administrative burdens on HCFA, its fiscal intermediaries and carriers, or investigators, providers, or participants in clinical trials. Explicit rules would have the added benefit of increasing the uniformity of reimbursement decisions made by Medicare fiscal intermediaries and carriers in different parts of the country. Greater uniformity would, in turn, decrease the uncertainty about reimbursement when providers and patients embark on a clinical trial.
Book Synopsis Extending Medicare Coverage for Preventive and Other Services by : Institute of Medicine
Download or read book Extending Medicare Coverage for Preventive and Other Services written by Institute of Medicine and published by National Academies Press. This book was released on 2000-05-07 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report, which was developed by an expert committee of the Institute of Medicine, reviews the first three services listed above. It is intended to assist policymakers by providing syntheses of the best evidence available about the effectiveness of these services and by estimating the cost to Medicare of covering them. For each service or condition examined, the committee commissioned a review of the scientific literature that was presented and discussed at a public workshop. As requested by Congress, this report includes explicit estimates only of costs to Medicare, not costs to beneficiaries, their families, or others. It also does not include cost-effectiveness analyses. That is, the extent of the benefits relative to the costs to Medicareâ€"or to society generallyâ€"is not evaluated for the services examined. The method for estimating Medicare costs follows the generic estimation practices of the Congressional Budget Office (CBO). The objective was to provide Congress with estimates that were based on familiar procedures and could be compared readily with earlier and later CBO estimates. For each condition or service, the estimates are intended to suggest the order of magnitude of the costs to Medicare of extending coverage, but the estimates could be considerably higher or lower than what Medicare might actually spend were coverage policies changed. The estimates cover the five-year period 2000-2004. In addition to the conclusions about specific coverage issues, the report examines some broader concerns about the processes for making coverage decisions and about the research and organizational infrastructure for these decisions. It also briefly examines the limits of coverage as a means of improving health services and outcomes and the limits of evidence as a means of resolving policy and ethical questions.
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Book Synopsis A National Cancer Clinical Trials System for the 21st Century by : Institute of Medicine
Download or read book A National Cancer Clinical Trials System for the 21st Century written by Institute of Medicine and published by National Academies Press. This book was released on 2010-07-08 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.
Book Synopsis Managed Care Systems and Emerging Infections by :
Download or read book Managed Care Systems and Emerging Infections written by and published by . This book was released on 2000 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Book Synopsis Envisioning a Transformed Clinical Trials Enterprise in the United States by : Institute of Medicine
Download or read book Envisioning a Transformed Clinical Trials Enterprise in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.
Book Synopsis The Oxford Textbook of Clinical Research Ethics by : Ezekiel J. Emanuel
Download or read book The Oxford Textbook of Clinical Research Ethics written by Ezekiel J. Emanuel and published by OUP USA. This book was released on 2011-02 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings. Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research. The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students.
Book Synopsis Documentation Guidelines for Evaluation and Management Services by : American Medical Association
Download or read book Documentation Guidelines for Evaluation and Management Services written by American Medical Association and published by American Medical Association Press. This book was released on 1995 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Handbook of Communication in Oncology and Palliative Care by : David Kissane
Download or read book Handbook of Communication in Oncology and Palliative Care written by David Kissane and published by Oxford University Press, USA. This book was released on 2010 with total page 774 pages. Available in PDF, EPUB and Kindle. Book excerpt: Communication is a core skill for medical professionals when treating patients, and cancer and palliative care present some of the most challenging clinical situations. This book provides a comprehensive curriculum to help oncology specialists optimize their communication skills.
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :396 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author :American Bar Association. House of Delegates Publisher :American Bar Association ISBN 13 :9781590318737 Total Pages :216 pages Book Rating :4.3/5 (187 download)
Book Synopsis Model Rules of Professional Conduct by : American Bar Association. House of Delegates
Download or read book Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
Book Synopsis The Role of Nutrition in Maintaining Health in the Nation's Elderly by : Institute of Medicine
Download or read book The Role of Nutrition in Maintaining Health in the Nation's Elderly written by Institute of Medicine and published by National Academies Press. This book was released on 2000-06-09 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: Malnutrition and obesity are both common among Americans over age 65. There are also a host of other medical conditions from which older people and other Medicare beneficiaries suffer that could be improved with appropriate nutritional intervention. Despite that, access to a nutrition professional is very limited. Do nutrition services benefit older people in terms of morbidity, mortality, or quality of life? Which health professionals are best qualified to provide such services? What would be the cost to Medicare of such services? Would the cost be offset by reduced illness in this population? This book addresses these questions, provides recommendations for nutrition services for the elderly, and considers how the coverage policy should be approached and practiced. The book discusses the role of nutrition therapy in the management of a number of diseases. It also examines what the elderly receive in the way of nutrition services along the continuum of care settings and addresses the areas of expertise needed by health professionals to provide appropriate nutrition services and therapy.
Download or read book The Medicare Handbook written by and published by . This book was released on with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Redesigning the Clinical Effectiveness Research Paradigm by : Institute of Medicine
Download or read book Redesigning the Clinical Effectiveness Research Paradigm written by Institute of Medicine and published by National Academies Press. This book was released on 2010-09-20 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent scientific and technological advances have accelerated our understanding of the causes of disease development and progression, and resulted in innovative treatments and therapies. Ongoing work to elucidate the effects of individual genetic variation on patient outcomes suggests the rapid pace of discovery in the biomedical sciences will only accelerate. However, these advances belie an important and increasing shortfall between the expansion in therapy and treatment options and knowledge about how these interventions might be applied appropriately to individual patients. The impressive gains made in Americans' health over the past decades provide only a preview of what might be possible when data on treatment effects and patient outcomes are systematically captured and used to evaluate their effectiveness. Needed for progress are advances as dramatic as those experienced in biomedicine in our approach to assessing clinical effectiveness. In the emerging era of tailored treatments and rapidly evolving practice, ensuring the translation of scientific discovery into improved health outcomes requires a new approach to clinical evaluation. A paradigm that supports a continual learning process about what works best for individual patients will not only take advantage of the rigor of trials, but also incorporate other methods that might bring insights relevant to clinical care and endeavor to match the right method to the question at hand. The Institute of Medicine Roundtable on Value & Science-Driven Health Care's vision for a learning healthcare system, in which evidence is applied and generated as a natural course of care, is premised on the development of a research capacity that is structured to provide timely and accurate evidence relevant to the clinical decisions faced by patients and providers. As part of the Roundtable's Learning Healthcare System series of workshops, clinical researchers, academics, and policy makers gathered for the workshop Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches. Participants explored cutting-edge research designs and methods and discussed strategies for development of a research paradigm to better accommodate the diverse array of emerging data resources, study designs, tools, and techniques. Presentations and discussions are summarized in this volume.
Book Synopsis Extending Medicare Coverage for Preventive and Other Services by : Institute of Medicine
Download or read book Extending Medicare Coverage for Preventive and Other Services written by Institute of Medicine and published by National Academies Press. This book was released on 2000-04-07 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report, which was developed by an expert committee of the Institute of Medicine, reviews the first three services listed above. It is intended to assist policymakers by providing syntheses of the best evidence available about the effectiveness of these services and by estimating the cost to Medicare of covering them. For each service or condition examined, the committee commissioned a review of the scientific literature that was presented and discussed at a public workshop. As requested by Congress, this report includes explicit estimates only of costs to Medicare, not costs to beneficiaries, their families, or others. It also does not include cost-effectiveness analyses. That is, the extent of the benefits relative to the costs to Medicareâ€"or to society generallyâ€"is not evaluated for the services examined. The method for estimating Medicare costs follows the generic estimation practices of the Congressional Budget Office (CBO). The objective was to provide Congress with estimates that were based on familiar procedures and could be compared readily with earlier and later CBO estimates. For each condition or service, the estimates are intended to suggest the order of magnitude of the costs to Medicare of extending coverage, but the estimates could be considerably higher or lower than what Medicare might actually spend were coverage policies changed. The estimates cover the five-year period 2000-2004. In addition to the conclusions about specific coverage issues, the report examines some broader concerns about the processes for making coverage decisions and about the research and organizational infrastructure for these decisions. It also briefly examines the limits of coverage as a means of improving health services and outcomes and the limits of evidence as a means of resolving policy and ethical questions.
Book Synopsis Cancer Clinical Trials by : Hans Scheurlen
Download or read book Cancer Clinical Trials written by Hans Scheurlen and published by Springer. This book was released on 2011-12-27 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The controlled clinical trial has become an essential part of the clinician's decision-making process. Clinical trials, however, still raise methodological problems that are important and at the same time controversial: subgroup analysis and interactions, meta-analy sis of similar trials, consideration of subjective clinical opinions and those of the public at large, assessment of quality of life, pre vention trials, and so on. In February 1987 we took our third step along the road to evaluating these issues in dialogues between cli nicians, psychologists, legal experts, and statisticians. The talks presented at the meeting were revised by the authors afterwards and have been rearranged by the editors to form a strictly organ 1 2 ized book. The two preceding meetings in 1978 and 1981 focused strongly on adjuvant therapy in primary breast cancer, but this top ic served merely as a nucleus in the third meeting. This meeting, although called the Third Heidelberg Symposium was forced to leave Heidelberg and in fact was held in Freiburg. Without the interest and enthusiasm of Professor Martin Schu macher and his colleagues in Freiburg the meeting would never have taken place. The meeting was generously supported again by the Federal Ministry of Research and Technology (Bundesministe rium flir Forschung und Technologie, BMFT) within the framework of the West German BMFT Breast Cancer Study Group. We are grateful, in particular, to Mr. Hans W. Herzog for his personal in volvement. Juni 1988 H. Scheurlen, R. Kay, M.
