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Author: Institute of Medicine Publisher: National Academies Press ISBN: 030918388X Category : Medical Languages : en Pages : 86
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 030918388X Category : Medical Languages : en Pages : 86
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309068894 Category : Medical Languages : en Pages : 410
Book Description
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.
Author: F. Lisa Murtha Publisher: Hcpro, a Division of Simplify Compliance ISBN: 9781601462244 Category : Clinical trials Languages : en Pages : 0
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309157870 Category : Medical Languages : en Pages : 317
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309158060 Category : Medical Languages : en Pages : 442
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 304
Book Description
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.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309498511 Category : Medical Languages : en Pages : 103
Book Description
To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Author: American Bar Association. House of Delegates Publisher: American Bar Association ISBN: 9781590318737 Category : Law Languages : en Pages : 216
Book Description
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.
Author: Institute of Medicine
Author: Institute of Medicine
Author: Institute of Medicine
Author: F. Lisa Murtha
Author: Institute of Medicine
Author: Institute of Medicine
Author: Institute of Medicine
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Author: National Academies of Sciences, Engineering, and Medicine
Author: American Bar Association. House of Delegates