Extending Medicare Reimbursement in Clinical Trials

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Author :
Publisher : National Academies Press
ISBN 13 : 030918388X
Total Pages : 86 pages
Book Rating : 4.3/5 (91 download)

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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.

The Healthcare Compliance Professional's Guide to Clinical Trials

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Author :
Publisher : Hcpro, a Division of Simplify Compliance
ISBN 13 : 9781601462244
Total Pages : 0 pages
Book Rating : 4.4/5 (622 download)

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Book Synopsis The Healthcare Compliance Professional's Guide to Clinical Trials by : F. Lisa Murtha

Download or read book The Healthcare Compliance Professional's Guide to Clinical Trials written by F. Lisa Murtha and published by Hcpro, a Division of Simplify Compliance. This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Billing for clinical trials is a focal point of government scrutiny, with several new CMS directives that mandate compliance with regulations for hospitals and university research facilities. The Healthcare Compliance Professional's Guide to Clinical Trials helps you sort through the various rules and establish policies and procedures that ensure Medicare-covered research is reimbursed appropriately. Professional's Guide to Clinical Trials Written by the Huron Consulting Group, a team of clinical research compliance experts, The Healthcare Compliance Professional's Guide to Clinical Trials will help ensure that your facility minimizes its compliance risk in the important research that it conducts. With this book, you can: *Customize forms to conduct a Medicare Coverage Analysis *Develop your own review plan based on proven sample auditing and monitoring templates *Analyze recent changes to the National Coverage Determination *Apply concepts from real-life clinical trial situations to your compliance program *Coordinate research and revenue teams The sample materials in this guide can be used right away. Download them from the companion CD-ROM and customize each document to fit your specific needs. It's that easy to develop a plan to ensure that your clinical trial research conforms to CMS regulations and that you receive the proper reimbursement.

Extending Medicare Coverage for Preventive and Other Services

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Author :
Publisher : National Academies Press
ISBN 13 : 0309068894
Total Pages : 410 pages
Book Rating : 4.3/5 (9 download)

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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.

A National Cancer Clinical Trials System for the 21st Century

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Author :
Publisher : National Academies Press
ISBN 13 : 0309157870
Total Pages : 317 pages
Book Rating : 4.3/5 (91 download)

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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.

Rare Diseases and Orphan Products

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Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)

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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.

Managed Care Systems and Emerging Infections

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Author :
Publisher :
ISBN 13 :
Total Pages : 113 pages
Book Rating : 4.:/5 (99 download)

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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:

The Role of Telehealth in an Evolving Health Care Environment

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Author :
Publisher : National Academies Press
ISBN 13 : 0309262011
Total Pages : 159 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis The Role of Telehealth in an Evolving Health Care Environment by : Institute of Medicine

Download or read book The Role of Telehealth in an Evolving Health Care Environment written by Institute of Medicine and published by National Academies Press. This book was released on 2012-12-20 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1996, the Institute of Medicine (IOM) released its report Telemedicine: A Guide to Assessing Telecommunications for Health Care. In that report, the IOM Committee on Evaluating Clinical Applications of Telemedicine found telemedicine is similar in most respects to other technologies for which better evidence of effectiveness is also being demanded. Telemedicine, however, has some special characteristics-shared with information technologies generally-that warrant particular notice from evaluators and decision makers. Since that time, attention to telehealth has continued to grow in both the public and private sectors. Peer-reviewed journals and professional societies are devoted to telehealth, the federal government provides grant funding to promote the use of telehealth, and the private technology industry continues to develop new applications for telehealth. However, barriers remain to the use of telehealth modalities, including issues related to reimbursement, licensure, workforce, and costs. Also, some areas of telehealth have developed a stronger evidence base than others. The Health Resources and Service Administration (HRSA) sponsored the IOM in holding a workshop in Washington, DC, on August 8-9 2012, to examine how the use of telehealth technology can fit into the U.S. health care system. HRSA asked the IOM to focus on the potential for telehealth to serve geographically isolated individuals and extend the reach of scarce resources while also emphasizing the quality and value in the delivery of health care services. This workshop summary discusses the evolution of telehealth since 1996, including the increasing role of the private sector, policies that have promoted or delayed the use of telehealth, and consumer acceptance of telehealth. The Role of Telehealth in an Evolving Health Care Environment: Workshop Summary discusses the current evidence base for telehealth, including available data and gaps in data; discuss how technological developments, including mobile telehealth, electronic intensive care units, remote monitoring, social networking, and wearable devices, in conjunction with the push for electronic health records, is changing the delivery of health care in rural and urban environments. This report also summarizes actions that the U.S. Department of Health and Human Services (HHS) can undertake to further the use of telehealth to improve health care outcomes while controlling costs in the current health care environment.

Envisioning a Transformed Clinical Trials Enterprise in the United States

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Author :
Publisher : National Academies Press
ISBN 13 : 0309253187
Total Pages : 248 pages
Book Rating : 4.3/5 (92 download)

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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.

Extending Medicare Coverage for Preventive and Other Services

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Author :
Publisher : National Academies Press
ISBN 13 : 0309183502
Total Pages : 410 pages
Book Rating : 4.3/5 (91 download)

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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.

The Oxford Textbook of Clinical Research Ethics

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Author :
Publisher : OUP USA
ISBN 13 : 0199768633
Total Pages : 848 pages
Book Rating : 4.1/5 (997 download)

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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.

Cancer Clinical Trials

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Publisher : Springer
ISBN 13 : 9783642834219
Total Pages : 0 pages
Book Rating : 4.8/5 (342 download)

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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.

Principles and Practice of Clinical Trials

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Author :
Publisher : Springer Nature
ISBN 13 : 3319526367
Total Pages : 2573 pages
Book Rating : 4.3/5 (195 download)

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Book Synopsis Principles and Practice of Clinical Trials by : Steven Piantadosi

Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

The Medicare Handbook

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Author :
Publisher :
ISBN 13 :
Total Pages : 60 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Medicare Handbook by :

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:

Registries for Evaluating Patient Outcomes

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Author :
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 396 pages
Book Rating : 4.5/5 (876 download)

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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.

Handbook of Communication in Oncology and Palliative Care

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Author :
Publisher : Oxford University Press, USA
ISBN 13 : 0199238367
Total Pages : 774 pages
Book Rating : 4.1/5 (992 download)

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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.

Documentation Guidelines for Evaluation and Management Services

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Author :
Publisher : American Medical Association Press
ISBN 13 :
Total Pages : 26 pages
Book Rating : 4.:/5 ( download)

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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:

Public Papers of the Presidents of the United States

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Publisher :
ISBN 13 :
Total Pages : 1386 pages
Book Rating : 4.A/5 ( download)

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Book Synopsis Public Papers of the Presidents of the United States by : United States. President

Download or read book Public Papers of the Presidents of the United States written by United States. President and published by . This book was released on 2001 with total page 1386 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Containing the public messages, speeches, and statements of the President", 1956-1992.