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| optum gene therapy risk protection: Making Medicines Affordable National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Care Services, Committee on Ensuring Patient Access to Affordable Drug Therapies, 2018-03-01 Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€and health care at largeâ€more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€coupled with the broader trends in overall health care costsâ€is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care. |
| optum gene therapy risk protection: Handbook of Healthcare Operations Management Brian T. Denton, 2013-02-28 From the Preface: Collectively, the chapters in this book address application domains including inpatient and outpatient services, public health networks, supply chain management, and resource constrained settings in developing countries. Many of the chapters provide specific examples or case studies illustrating the applications of operations research methods across the globe, including Africa, Australia, Belgium, Canada, the United Kingdom, and the United States. Chapters 1-4 review operations research methods that are most commonly applied to health care operations management including: queuing, simulation, and mathematical programming. Chapters 5-7 address challenges related to inpatient services in hospitals such as surgery, intensive care units, and hospital wards. Chapters 8-10 cover outpatient services, the fastest growing part of many health systems, and describe operations research models for primary and specialty care services, and how to plan for patient no-shows. Chapters 12 – 16 cover topics related to the broader integration of health services in the context of public health, including optimizing the location of emergency vehicles, planning for mass vaccination events, and the coordination among different parts of a health system. Chapters 17-18 address supply chain management within hospitals, with a focus on pharmaceutical supply management, and the challenges of managing inventory for nursing units. Finally, Chapters 19-20 provide examples of important and emerging research in the realm of humanitarian logistics. |
| optum gene therapy risk protection: Evidence-Based Management of Sickle Cell Disease M D George R Buchanan, M D M P H Araba N Afenyi-Annan, M D Samir K Ballas, 2014-09-09 Sickle cell disease can be severe and disabling. When properly treated, patients live longer and with better quality life. This is a US government publication intended to provide evidence-based guidelines for the care of these patients for the use of all concerned providers as well as patients and family members. This book is available in print here for convenience. |
| optum gene therapy risk protection: The Future of Medical Practice , 1994 Presents an analysis of forces affecting the environment of medical practice. Also, lists potential trends likely to influence medicine in the coming years. |
| optum gene therapy risk protection: The Prevention and Treatment of Missing Data in Clinical Trials National Research Council, Division of Behavioral and Social Sciences and Education, Committee on National Statistics, Panel on Handling Missing Data in Clinical Trials, 2010-12-21 Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data. |
| optum gene therapy risk protection: The Promise of Assistive Technology to Enhance Activity and Work Participation National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Care Services, Committee on the Use of Selected Assistive Products and Technologies in Eliminating or Reducing the Effects of Impairments, 2017-09-01 The U.S. Census Bureau has reported that 56.7 million Americans had some type of disability in 2010, which represents 18.7 percent of the civilian noninstitutionalized population included in the 2010 Survey of Income and Program Participation. The U.S. Social Security Administration (SSA) provides disability benefits through the Social Security Disability Insurance (SSDI) program and the Supplemental Security Income (SSI) program. As of December 2015, approximately 11 million individuals were SSDI beneficiaries, and about 8 million were SSI beneficiaries. SSA currently considers assistive devices in the nonmedical and medical areas of its program guidelines. During determinations of substantial gainful activity and income eligibility for SSI benefits, the reasonable cost of items, devices, or services applicants need to enable them to work with their impairment is subtracted from eligible earnings, even if those items or services are used for activities of daily living in addition to work. In addition, SSA considers assistive devices in its medical disability determination process and assessment of work capacity. The Promise of Assistive Technology to Enhance Activity and Work Participation provides an analysis of selected assistive products and technologies, including wheeled and seated mobility devices, upper-extremity prostheses, and products and technologies selected by the committee that pertain to hearing and to communication and speech in adults. |
| optum gene therapy risk protection: Coders' Desk Reference for Procedures 2021 , 2020-12 |
| optum gene therapy risk protection: Network Pharmacology Shao Li, 2021-09-29 This book introduces “network pharmacology” as an emerging frontier subject of systematic drug research in the era of artificial intelligence and big data. Network Pharmacology is an original subject of fusion system biology, bioinformatics, network science and other related disciplines. It emphasizes on starting from the overall perspective of the system level and biological networks, the analysis of the laws of molecular association between drugs and their treatment objects, reveals the systematic pharmacological mechanisms of drugs, and guides the research and development of new drugs and clinical diagnosis and treatment. After it was proposed, network pharmacology has been paid attention by researchers, and it has been rapidly developed and widely used. In order to systematically reveal the biological basis of diagnosis and treatment in traditional Chinese medicine and modern medicine, we proposed a new concept of network target for the first time, which has become the core theory of network pharmacology. The core principle of a network target is to construct a biological network that can be used to decipher complex diseases. The network is then used as the therapeutic target, to which multicomponent remedies are applied. This book mainly includes four parts: 1) The concept and theory of network pharmacology; 2) Common analysis methods, databases and software in network pharmacological research; 3) Typical cases of traditional Chinese medicine modernization and modern drug research based on network pharmacology; 4) Network pharmacology practice process based on drugs and diseases. |
| optum gene therapy risk protection: Principles and Practice of Clinical Trials Steven Piantadosi, Curtis L. Meinert, 2022-07-19 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. |
| optum gene therapy risk protection: Advancing Healthcare Through Personalized Medicine Priya Hays, 2021-09-27 This book provides a unique perspective on the biomedical and societal implications of personalized medicine and how it helps to mitigate the healthcare crisis and rein in ever-growing expenditure. It introduces the reader to the underlying concepts at the heart of personalized medicine. An innovative second edition, this book functions as an update to the successful first edition to include new, state-of-the-art information and advancements in the fast-paced field of personalized medicine. Chapters examine pharmacogenomics, targeted therapies, individualized diagnosis and treatment, and cancer immunotherapies. The book also features an essential discussion on how the advent of genomic technologies gives clinicians the capability to predict and diagnose disease more efficiently and offers a detailed up-to-date compilation of clinical trials in cancer leading to breakthrough therapies. The book also addresses the impact of Big Data on personalized medicine and the newfound applications of digital health and artificial intelligence. A work that advocates for a patient-centered approach, Advancing Healthcare Through Personalized Medicine, Second Edition is an invaluable text for clinicians, healthcare providers, and patients. |
| optum gene therapy risk protection: Graduate Medical Education Outcomes and Metrics National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Care Services, 2018-05-30 Graduate medical education (GME) is critical to the career development of individual physicians, to the functioning of many teaching institutions, and to the production of our physician workforce. However, recent reports have called for substantial reform of GME. The current lack of established GME outcome measures limits our ability to assess the impact of individual graduates, the performance of residency programs and teaching institutions, and the collective contribution of GME graduates to the physician workforce. To examine the opportunities and challenges in measuring and assessing GME outcomes, the National Academies of Sciences, Engineering, and Medicine held a workshop on October 10â€11, 2017, in Washington, DC. Workshop participants discussed: meaningful and measurable outcomes of GME; possible metrics that could be used to track these GME outcomes; possible mechanisms for collecting, collating, analyzing, and reporting these data; and further work to accomplish this ambitious goal. This publication summarizes the presentations and discussions from the workshop. |
| optum gene therapy risk protection: Section 1557 of the Affordable Care Act American Dental Association, 2017-05-24 Section 1557 is the nondiscrimination provision of the Affordable Care Act (ACA). This brief guide explains Section 1557 in more detail and what your practice needs to do to meet the requirements of this federal law. Includes sample notices of nondiscrimination, as well as taglines translated for the top 15 languages by state. |
| optum gene therapy risk protection: Bayesian Approaches to Clinical Trials and Health-Care Evaluation David J. Spiegelhalter, Keith R. Abrams, Jonathan P. Myles, 2004-01-16 READ ALL ABOUT IT! David Spiegelhalter has recently joined the ranks of Isaac Newton, Charles Darwin and Stephen Hawking by becoming a fellow of the Royal Society. Originating from the Medical Research Council’s biostatistics unit, David has played a leading role in the Bristol heart surgery and Harold Shipman inquiries. Order a copy of this author’s comprehensive text TODAY! The Bayesian approach involves synthesising data and judgement in order to reach conclusions about unknown quantities and make predictions. Bayesian methods have become increasingly popular in recent years, notably in medical research, and although there are a number of books on Bayesian analysis, few cover clinical trials and biostatistical applications in any detail. Bayesian Approaches to Clinical Trials and Health-Care Evaluation provides a valuable overview of this rapidly evolving field, including basic Bayesian ideas, prior distributions, clinical trials, observational studies, evidence synthesis and cost-effectiveness analysis. Covers a broad array of essential topics, building from the basics to more advanced techniques. Illustrated throughout by detailed case studies and worked examples Includes exercises in all chapters Accessible to anyone with a basic knowledge of statistics Authors are at the forefront of research into Bayesian methods in medical research Accompanied by a Web site featuring data sets and worked examples using Excel and WinBUGS - the most widely used Bayesian modelling package Bayesian Approaches to Clinical Trials and Health-Care Evaluation is suitable for students and researchers in medical statistics, statisticians in the pharmaceutical industry, and anyone involved in conducting clinical trials and assessment of health-care technology. |
| optum gene therapy risk protection: Statin-Associated Muscle Symptoms Paul D. Thompson, Beth A. Taylor, 2020-01-25 This book provides an overview of statin-associated muscle symptoms (SAMS) from clinical presentation to treatment and possible metabolic causes. It examines the risk factors, presentations, diagnosis and differential diagnosis, clinical management, and financial costs of SAMS. The book also highlights patients’ perspectives on SAMS such as the psychosocial, emotional, and societal factors influencing their perceptions and experiences. Finally, the book presents the results of observational and clinical trials on the prevalence of SAMS, clinical trials for treatments, and potential future research approaches for improving the understanding and treatment of SAMS. A key addition to the Contemporary Cardiology series, Statin-Associated Muscle Symptoms is an essential resource for physicians, medical students, residents, fellows, and allied health professionals in cardiology, endocrinology, pharmacotherapy, primary care, and health promotion and disease prevention. |
| optum gene therapy risk protection: Health Care Fraud and Abuse Aspen Health Law Center, 1998 Stepped-up efforts to ferret out health care fraud have put every provider on the alert. The HHS, DOJ, state Medicaid Fraud Control Units, even the FBI is on the case -- and providers are in the hot seat! in this timely volume, you'll learn about the types of provider activities that fall under federal fraud and abuse prohibitions as defined in the Medicaid statute and Stark legislation. And you'll discover what goes into an effective corporate compliance program. With a growing number of restrictions, it's critical to know how you can and cannot conduct business and structure your relationships -- and what the consequences will be if you don't comply. |
| optum gene therapy risk protection: The ASCRS Textbook of Colon and Rectal Surgery Scott R. Steele, Tracy L. Hull, Thomas E. Read, Theodore J. Saclarides, Anthony J. Senagore, Charles B. Whitlow, 2016-03-24 This third edition text provides a completely revised and updated new version of this unique, modern, practical text that covers the strategic evaluation, specific approaches, and detailed management techniques utilized by expert colorectal surgeons caring for patients with complex problems–whether they result from underlying colorectal disease or from complications arising from previous surgical therapy. The format follows that of both a “how to” manual as well as an algorithm-based guide to allow the reader to understand the thought process behind the proposed treatment strategy. By making use of evidence-based recommendations, each chapter includes not only background information and diagnostic/therapeutic guidelines, but also provides a narrative by the author on his/her operative technical details and perioperative “tips and tricks” that they utilize in the management of these complex surgical challenges. Distinctive to this book, is the reliance on experts in the field including past presidents of the ASCRS, as well as multiple other national and internationally recognized surgeons, to lend their personal insight into situations where data may be more sparse, but individual and collective experience is paramount to making sound decisions and thereby optimizing patient outcomes. The text includes chapters on the assessment of risk and methods utilized to minimize perioperative complications. In addition, it incorporates sections covering the medical and surgical therapies for abdominal, pelvic and anorectal disease. Moreover, the technical challenges of managing complications resulting from the original or subsequent operations is addressed. The underlying focus throughout the text is on providing pragmatic and understandable solutions that can be readily implemented by surgeons of varying experience to successfully treat complex colorectal problems. However, it also goes beyond the technical aspects of colorectal surgery and includes special sections highlighting the essence of a surgeon; covering aspects involving the medical-legal, ethical, and economic challenges confronting surgeons. Throughout the text, each author provides an ongoing narrative of his/her individual surgical techniques along with illustrations and diagrams to “personally” take the reader through the crucial steps of the procedure, and key points of patient care inherent to that topic. Additionally, where appropriate, links to online videos give the reader an up-front look into technical aspects of colorectal surgery. |
| optum gene therapy risk protection: Global Innovation Index 2019: Creating Healthy Lives — The Future of Medical Innovation World Intellectual Property Organization, INSEAD, Cornell University, 2019-07-24 The Global Innovation Index 2019 provides detailed metrics about the innovation performance of 129 countries and economies around the world. Its 80 indicators explore a broad vision of innovation, including political environment, education, infrastructure and business sophistication. The GII 2019 analyzes the medical innovation landscape of the next decade, looking at how technological and non-technological medical innovation will transform the delivery of healthcare worldwide. It also explores the role and dynamics of medical innovation as it shapes the future of healthcare, and the potential influence this may have on economic growth. Chapters of the report provide more details on this year’s theme from academic, business, and particular country perspectives from leading experts and decision makers. |
| optum gene therapy risk protection: Non-tubal Ectopic Pregnancy Julio Elito Jr., 2020-03-25 Non-Tubal Ectopic Pregnancy is a comprehensive book, written in an organized and concise format. The book offers an immersion into non-tubal ectopic pregnancy and the reader is invited, chapter after chapter, to visit the most important aspects of non-tubal ectopic pregnancies. The book covers all aspects of non-tubal ectopic pregnancies including epidemiology, diagnosis, and management. Experts from all over the world have contributed to it, bringing the best from their research.The book presents the reader with the latest advances on non-tubal ectopic pregnancies. |
| optum gene therapy risk protection: Medical Device Epidemiology and Surveillance S. Lori Brown, Roselie A. Bright, Dale R. Tavris, 2007-03-13 Medical devices are crucial in medical care today and device technology advances at a dizzying pace. Medical Device Epidemiology and Surveillance is the first book to provide an overview of medical device epidemiology and surveillance as well as perspectives from regulatory agencies, the medical device industry, the health insurance industry and academia. The book is edited by experts from the US Food and Drug Administration with contributions from experienced specialists working in this field in the US and around the world. It features chapters describing broad themes in medical device epidemiology and surveillance, as well as chapters that describe specific medical devices. Medical Device Epidemiology and Surveillance is an essential reference for epidemiologists, pharmacoepidemiologists, academics, graduate students, and everybody working in the medical device industry. |
| optum gene therapy risk protection: Clinical Lipidology Christie M. Ballantyne, 2009-01-01 Clinical Lipidology, a companion to Braunwald's Heart Disease, is designed to guide you through the ever-changing therapeutic management of patients with high cholesterol levels. From basic science to pathogenesis of atherothrombotic disease, to risk assessment and the latest therapy options, this medical reference book offers unparalleled coverage and expert guidance on lipidology in a straightforward, accessible, and user-friendly style. Get authoritative guidance from some of the foremost experts in the field. Easily access key content with help from treatment algorithms. Access options and evidence-based solutions for every type of patient scenario, as well as the latest clinical guidelines and clinically relevant evidence on risk assessment, special patient populations, and therapy, including recently approved and experimental therapies. Remain at the forefront of the cardiology field with up-to-date chapters on treatment guidelines; diet, exercise, and weight loss; pharmacologic therapies such as statins, omega-3 fatty acids, and combination therapy; evolving targets of therapy such as PCSK9 inhibition, CETP inhibition, and inflammation Prepare for special patient populations such as children and adolescents; women and the elderly; transplant recipients; HIV patients; and those with chronic renal disease, familial hypercholesterolemia, other severe hypercholesterolemias, diabetes, or other metabolic syndromes. Take advantage of a format that follows that of the well-known and internationally recognized Braunwald's Heart Disease. Expert Consult eBook version included with purchase. |
| optum gene therapy risk protection: Cancer in the Elderly Carrie P. Hunter, Karen A. Johnson, Hyman B. Muss, 2000-03-01 This book presents comprehensive assessment and up-to-date discussion of the epidemiology, prevention, and treatment of cancer in the elderly, highlighting the growing demands of the disease, its biology, individual susceptibility, the impact of state-of-the-art and emerging therapies on reducing morbidity, and decision making processes. Describ |
| optum gene therapy risk protection: Health Care Technology and Its Assessment Henry David Banta, Bryan R. Luce, 1993 Since 1945, a broad array of health care technologies have come into use, including antibiotics, anti-hypertensive drugs, oral diuretics, oral contraceptives, psycho-pharmaceuticals, corticosteroids, vaccines, open-heart surgery, genetics screening, automated clinical laboratories, renal dialysis, and cardiac pacemakers. Unquestionably, these technologies have brought benefits to millions. However, as costs of health care have risen rapidly, governments have increasingly singled out expensive technology as the culprit. The result has been changes in the methods of paying for health care in most countries to control cost rises. This has led to a slowing of technological change in some countries and increasing necessities to choose in all countries. This timely work describes how technology assessment critically evaluates the benefits, costs, and social implications of technology. The book presents an international perspective on health care technology's development and diffusion, and explains how health care technology can enlighten difficult choices faced by policy-makers, clinicians, and patients. |
| optum gene therapy risk protection: Profiles of , 1996 |
| optum gene therapy risk protection: Step-By-Step Medical Coding, 2017 Edition Carol J. Buck, 2016-12-06 Resource ordered for the Health Information Technology program 105301. |
| optum gene therapy risk protection: Medical and Dental Expenses , 1990 |
| optum gene therapy risk protection: Protein Kinase Inhibitors as Sensitizing Agents for Chemotherapy , 2018-11-21 Tyrosine Kinase Inhibitors as Sensitizing Agents for Chemotherapy, the fourth volume in the Cancer Sensitizing Agents for Chemotherapy Series, focuses on strategic combination therapies that involve a variety of tyrosine kinase inhibitors working together to overcome multi-drug resistance in cancer cells. The book discusses several tyrosine kinase inhibitors that have been used as sensitizing agents, such as EGFR, BCR-ABL, ALK and BRAF. In each chapter, readers will find comprehensive knowledge on the inhibitor and its action, including its biochemical, genetic, and molecular mechanisms' emphases. This book is a valuable source for oncologists, cancer researchers and those interested in applying new sensitizing agents to their research in clinical practice and in trials. - Summarizes the sensitizing role of some tyrosine kinase inhibitors in existing research - Brings recent findings in several cancer types, both experimental and clinically, with a particular emphases on underlying biochemical, genetic, and molecular mechanisms - Provides an updated and comprehensive knowledge regarding the field of combinational cancer treatment |
| optum gene therapy risk protection: PharmPrep: ASHP's NAPLEX Review Lea S. Eiland, Diane B. Ginsburg, 2011-05-20 After years of studying and hard work, you’re almost a licensed pharmacist! The final step is passing the North American Pharmacy Licensure Examination, or the NAPLEX®. For the last decade, PharmPrep: ASHP’s NAPLEX® Review, has been a trusted resource with new graduates preparing for the NAPLEX examination, both as an online product and a print companion.Using real patient cases accompanied by questions that address all NAPLEX® competency statements, the new fully updated PharmPrep: ASHP’s NAPLEX® Review, 4th edition, gives you the flexibility to review information by specific disease state and provides 78 sample cases, as well as calculations and law review sections. As drug therapy becomes more complex, PharmPrep has continued to update and revise cases so they reflect contemporary clinical practice.PharmPrep is an equally important reference for the experienced practitioner as a tool for pharmacists to continue to develop professionally, or for out of practice professionals looking to refresh their skills. Only PharmPrep has case-based questions and detailed explanations that don’t just tell you what answers are right or wrong, but why. It is the the most affordable, trusted resource available to prepare for the NAPLEX® exam. As a book or in a convenient online/book package, PharmPrep goes where you go—on the subway, in the break room, to the coffeehouse. Or, just cozy up to the PharmPrep book from the comforts of home. Wherever you go, its the best resource to get you passed and ready to practice.To learn more about PharmPrep Online, visit www.pharmpreponline.com and sign up for a free trial today. Don’t have an ASHP account? Simply register at www.ashp.org. |
| optum gene therapy risk protection: Graduate Medical Education that Meets the Nation's Health Needs Institute of Medicine (U.S.). Committee on the Governance and Financing of Graduate Medical Education, Board on Health Care Services, 2014 Intro -- FrontMatter -- Reviewers -- Foreword -- Acknowledgments -- Contents -- Boxes, Figures, and Tables -- Summary -- 1 Introduction -- 2 Background on the Pipeline to the Physician Workforce -- 3 GME Financing -- 4 Governance -- 5 Recommendations for the Reform of GME Financing and Governance -- Appendix A: Abbreviations and Acronyms -- Appendix B: U.S. Senate Letters -- Appendix C: Public Workshop Agendas -- Appendix D: Committee Member Biographies -- Appendix E: Data and Methods to Analyze Medicare GME Payments -- Appendix F: Illustrations of the Phase-In of the Committee's Recommendations. |
| optum gene therapy risk protection: Epigenetics and Metabolomics Paban K. Agrawala, Poonam Rana, 2021-08-25 Epigenetics and Metabolomics, a new volume in the Translational Epigenetics series, offers a synthesized discussion of epigenetic control of metabolic activity, and systems-based approaches for better understanding these mechanisms. Over a dozen chapter authors provide an overview of epigenetics in translational medicine and metabolomics techniques, followed by analyses of epigenetic and metabolomic linkage mechanisms likely to result in effective identification of disease biomarkers, as well as new therapies targeting the removal of the inappropriate epigenetic alterations. Epigenetic interventions in cancer, brain damage, and neuroendocrine disease, among other disorders, are discussed in-depth, with an emphasis on exploring next steps for clinical translation and personalized healthcare. - Offers a synthesized discussion of epigenetic regulation of metabolic activity and systems-based approaches to power new research - Discusses epigenetic control of metabolic pathways and possible therapeutic targets for cancer, neurodegenerative, and neuroendocrine diseases, among others - Provides guidance in epigenomics and metabolomic research methodology |
| optum gene therapy risk protection: Relieving Pain in America Institute of Medicine, Board on Health Sciences Policy, Committee on Advancing Pain Research, Care, and Education, 2011-10-26 Chronic pain costs the nation up to $635 billion each year in medical treatment and lost productivity. The 2010 Patient Protection and Affordable Care Act required the Department of Health and Human Services (HHS) to enlist the Institute of Medicine (IOM) in examining pain as a public health problem. In this report, the IOM offers a blueprint for action in transforming prevention, care, education, and research, with the goal of providing relief for people with pain in America. To reach the vast multitude of people with various types of pain, the nation must adopt a population-level prevention and management strategy. The IOM recommends that HHS develop a comprehensive plan with specific goals, actions, and timeframes. Better data are needed to help shape efforts, especially on the groups of people currently underdiagnosed and undertreated, and the IOM encourages federal and state agencies and private organizations to accelerate the collection of data on pain incidence, prevalence, and treatments. Because pain varies from patient to patient, healthcare providers should increasingly aim at tailoring pain care to each person's experience, and self-management of pain should be promoted. In addition, because there are major gaps in knowledge about pain across health care and society alike, the IOM recommends that federal agencies and other stakeholders redesign education programs to bridge these gaps. Pain is a major driver for visits to physicians, a major reason for taking medications, a major cause of disability, and a key factor in quality of life and productivity. Given the burden of pain in human lives, dollars, and social consequences, relieving pain should be a national priority. |
| optum gene therapy risk protection: Technical Manual , 1942 |
| optum gene therapy risk protection: Health Information Management Technology, 6e Nanette Sayles, 2020-03-31 |
| optum gene therapy risk protection: Current Challenges in Pharmacovigilance World Health Organization, Council for International Organizations of Medical Sciences, Cioms, 2001-01-01 In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals. |
| optum gene therapy risk protection: Microeconometrics Using Stata, Revised Edition A. Colin Cameron, Pravin K. Trivedi, 2010-03-09 A complete and up-to-date survey of microeconometric methods available in Stata, Microeconometrics Using Stata, Revised Edition is an outstanding introduction to microeconometrics and how to execute microeconometric research using Stata. It covers topics left out of most microeconometrics textbooks and omitted from basic introductions to Stata. This revised edition has been updated to reflect the new features available in Stata 11 that are useful to microeconomists. Instead of using mfx and the user-written margeff commands, the authors employ the new margins command, emphasizing both marginal effects at the means and average marginal effects. They also replace the xi command with factor variables, which allow you to specify indicator variables and interaction effects. Along with several new examples, this edition presents the new gmm command for generalized method of moments and nonlinear instrumental-variables estimation. In addition, the chapter on maximum likelihood estimation incorporates enhancements made to ml in Stata 11. Throughout the book, the authors use simulation methods to illustrate features of the estimators and tests described and provide an in-depth Stata example for each topic discussed. They also show how to use Stata’s programming features to implement methods for which Stata does not have a specific command. The unique combination of topics, intuitive introductions to methods, and detailed illustrations of Stata examples make this book an invaluable, hands-on addition to the library of anyone who uses microeconometric methods. |
| optum gene therapy risk protection: Healthcare Operations Management Daniel B. McLaughlin, John R. Olson (Professor), 2017 |
| optum gene therapy risk protection: Building Better Governance , 2007 |
| optum gene therapy risk protection: Life Interrupted Suleika Jaouad, 2014-07-11 A compilation of articles written by and about Suleika Jaouad and a journey through cancer from age 22.My life was interrupted overnight. But guess what? That interruption was the best thing that's ever happened to me. I would never go so far as to say cancer is a gift. It's not. And I've seen it take way too many lives, way too soon. But when I found out I had cancer, I also began to find my voice. |
| optum gene therapy risk protection: Biology Digest , 1985-12 |
Optum Gene Therapy Risk Protection Full PDF
Optum Gene Therapy Risk Protection: Making Medicines Affordable National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies,2018-03-01
New Treatment Options for Sickle Cell Disease
Protection Program, or UHC/OptumRx's Gene Therapy Risk Protection program will include Casgevy and Lyfgenia is not yet known, as it is still being evaluated. Vertex will make Casgevy available at nine sites across six states and Washington, D.C., while Bluebird said that
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Gene therapy Next-generation IO bispecifics Weight management and risk factors Beyond 2030 Brilinta Farxiga ... for cardiometabolic organ protection 7 1. TriNetX (US EHR data), November 2020 and Optum claims data. Obesity defined as ICD10 codes E66.0, E66.1 , E66.2, E66.8, E66.9. Obesity defined as BMI > 30, Overweight as BMI 25-29.9.
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Monthly updates for March 2022 - OptumRx
Hemgenix is the fifth gene therapy to come to market and is the highest cost gene therapy to date . The wholesale acquisition cost (WAC) is $3.5 million for a one- time dose. Other gene therapies range from $850,000 to $3 million. The Optum Rx National Pharmacy & Therapeutics Committee is thoroughly assessing Hemgenix for clinical value
Optum Gene Therapy Risk Protection Copy
Optum Gene Therapy Risk Protection M D George R Buchanan,M D M P H Araba N Afenyi-Annan,M D Samir K Ballas. Optum Gene Therapy Risk Protection: Handbook of Healthcare Operations Management Brian T. Denton,2013-02-28 From the Preface Collectively the chapters
Optum Gene Therapy Risk Protection - interactive.cornish.edu
Decoding Optum Gene Therapy Risk Protection: Revealing the Captivating Potential of Verbal Expression In a time characterized by interconnectedness and an insatiable thirst for knowledge, the captivating potential of verbal expression has emerged as a formidable force. Its power to evoke sentiments, stimulate introspection, and incite profound
Clinical Criteria, Step Therapy, and Quantity Limits for ... - OptumRx
• Disease is positive for ROS1 gene fusions; AND • Patient have received at least one prior therapy; AND • Prescribed by, or in consultation with, an oncologist; AND • For patients with reproductive potential, prescriber attest to all of the following: o Patient is not pregnant prior to initiation of therapy
The people of Optum are helping - UnitedHealth Group
15 Optum Optum Insight Optum Insight provides technology-enabled services built on the foundation of our health care focus, advanced analytics and cross-industry connections to help customers reduce costs, better manage risk and quality, and grow revenue. We connect the health care system with trusted services,
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Optum Gene Therapy Risk Protection: Making Medicines Affordable National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies,2018-03-01
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Optum Gene Therapy Risk Protection optum-gene-therapy-risk-protection 3 Downloaded from oldshop.whitney.org on 2022-11-07 by guest 5. Accessing Optum Gene Therapy Risk Protection Free and Paid eBooks Optum Gene Therapy Risk Protection Public Domain eBooks Optum Gene Therapy Risk Protection eBook Subscription Services Optum Gene Therapy Risk ...
Optum Gene Therapy Risk Protection Full PDF
Optum Gene Therapy Risk Protection: Making Medicines Affordable National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies,2018-03-01
Medicare Outpatient Skilled Therapy (PT/OT/ST)
therapy services, and who also may appropriately furnish therapy services under Medicare policies. Qualified professional may also include a physical therapist assistant (PTA) or an occupational therapy assistant (OTA) when furnishing services under the supervision of a qualified therapist, who is working within the state scope of practice in
How to combine risk and quality: Secrets from the pros - Optum
optum.com Page 2 How to combine risk and quality: Secrets from the pros Executive summary As providers move to a value-based payment structure to get more for the value they provide, payers need to incentivize properly to achieve their quality …
A FRAMEWORK TO STRENGTHEN HEALTH SYSTEMS FOR GENE THERAPY …
licensed cell and gene therapy medicines annually by 2025 in the United States alone.6,7 While gene therapies represent a radical shift in the potential for improving outcomes for people with rare diseases, their implementation also poses substantial and …
Optum White Paper_Data that Makes a Difference
Data that makes a difference: The Optum Risk Score Page 4 What is the Optum Risk Score? Optum Predictive Analytics use one of the industry’s largest datasets, in combination with clinical guidelines and benchmarks, to support clinical intervention needs. As part of the analysis, subject matter experts curate a trigger-based model to
Overview of comments received on ICH guideline S12 on …
Animal Protection in Pharmaceutical Programs (ICAPPP) ... of study outcomes and thus human risk overestimation or underestimation, which could lead to either exclusion of ... of the GTMP [gene therapy medicinal product] are studied, including the tropism for multiple types of cells that
TERM Domestic Violence Victim Group Psychotherapy Treatment …
Risk Factors Individual, interpersonal, community and socfaialc tors influence risk for intimate partner violence (Crandall, Nathens, Kernic, Holt & Rivara, . High risk g2004roups) for victimization noted inthe li terature include females between …
HSA qualified medical expenses - Optum
Health savings accounts (HSAs) are individual accounts offered or administered through Optum Bank®, Member FDIC, a subsidiary of Optum Financial, Inc., and are subject to eligibility requirements and restrictions on deposits and withdrawals to avoid IRS penalties. Optum Financial, Inc. is not a bank or an FDIC insured institution.
Gene Therapy Solutions: Medical Breakthroughs Shouldn’t have …
Here is how Amwins Gene Therapy Solutions works: *Program disbursements are subject to coverage terms and exclusions. **Amwins Gene Therapy Solutions addresses Spinal Muscular Atrophy as a disease state. While Spinraza is not classified as a gene therapy treatment, it is a chronic specialty therapy for patients with SMA.
Group Risk Analytics - Optum
optum.com Page 2 Group Risk Analytics What is Group Risk Analytics? Optum® Group Risk Analytics provides an advantage to payers by predicting future risk, enabling competitive premium rates on the most attractive groups. We use de-identified, third-party data — including medical and pharmacy — and proprietary risk scoring to enable payers to
Managing the hallenges of Paying for Gene Therapy: Strategies
Paying for Gene Therapy: Strategies for Market Action and Policy Reform April 23, 2024 Sharon Phares, PhD, MPH Associate Director for Research ... of risk inherent in drug discovery and the need to incentivize the development of drugs that produce substantial health gains, health economists and governments outside the US have favored ...
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Cell Gene Therapy Guidance - canada.ca
Environmental Protection Act, 1999 (the Act) or the Regulations. In the event of an inconsistency between this document and the Act and/or the Regulations, the Act and the Regulations prevail. 1. GENERAL GUIDANCE 1.1 Regulatory Obligations under the Canadian Environmental Protection Act, 1999 and the Food and Drugs Act
Enhance Your Stop Loss Coverage - Excess Reinsurance …
Reinsurance developed its Gene Therapy Protection policy enhancement to address this new risk. Gene Therapy Protection provides clients with coverage enhancements for specific drugs by reducing their liability related to these drugs to the state minimum stop loss deductible. When implemented, the cost of the gene therapy drug is completely ...
Formulary Update - OptumRx
2 Dec 2021 · which includes agents such as monoclonal antibodies, cell therapy, and gene therapies. While cancer therapy still leads as a top class in gene therapy, rare diseases are the second most common area. Rare diseases typically affect less than 200,000 people in the U.S. and medications for these conditions usually get Orphan Designation from the ...
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Optum Gene Therapy Risk Protection: In today digital age, eBooks have become a staple for both leisure and learning. The convenience of accessing Optum Gene Therapy Risk Protection and various genres has transformed the way we consume literature. Whether you are a voracious
Gene Therapy Solutions: Medical Breakthroughs Shouldn’t have …
22 Sep 2023 · Your benefits strategy relies on cost-containment solutions to provide financial protection. Still, the importance of ... life-changing treatments but also present significant financial risk to self-funded plan sponsors. Our mission is to support our broker partners ... Gene Therapy Solutions covers Hemgenix and Beqvez for the treatment of ...
Symmetry Episode Risk Groups - Optum
Symmetry Episode Risk Groups optum.com Page 5 If there is such variation, the episodes are split into 2, 3 or 4 severity levels. ... The exception to this rule is anti-neoplastic chemotherapy and radiation therapy. Because of the high clinical stakes involved with these therapies, the decision to pursue anti-neoplastic treatment is ...
Gene Therapy A Practical Guide Book - EHC
If that does not happen, we risk uninformed gene therapy uptake or no gene therapy at all. At an individual patient level, patient organisations and stakeholders will need to address issues such as answering questions, ... improvement in baseline protection and reduces the infusion burden thanks to subcutaneous injections. However, it does not ...
GENE AND CELL THERAPIES: DEALING WITH RISING COVERAGE …
• Zolgensma (USD 2.1 million): Gene therapy for children under two years of age with spinal muscular atrophy. • Luxterna (USD 850,000–both eyes): Gene therapy to treat blindness caused by retinal dystrophy. • Abecma (USD 420,000): Cell therapy used as a fifth line of defense against multiple myeloma.
Emerging Applications of CAR T-cell Therapy in Cancer
Failure to autologous HCT or >=3 lines of therapy • Short duration of remission with 2. nd. or subsequent line of therapy • Presence of co-morbidities • Organ function is relevant but well controlled comorbidities and age should not be a barrier to CAR-T therapy • Age should not be a barrier to successful CAR-T therapy
The Impact of Reinsurance of Gene Therapies on Employer Financial Risk
claims payouts and the risk of unanticipated losses rise in step with the cost of innovation. Self-funded plans, authorized by the Early Retirement Income Security Act (ERISA), come in 2 varieties. In a totally self-funded plan, the employer is responsible for all insurable risk and pays claims through a third-party administrator. Totally self ...
Application of protection motivation theory to clinical trial …
osis gene therapy, including pediatric use [4]. Despite their promise, the risk profile of ATMPs for chronic pediatric conditions is largely unknown. This risk profile is likely different than for terminal pediatric illnesses, such as hematopoietic stem cell transplantation for …
Raw materials for the production of cell-based and gene therapy …
and other reference texts on the protection of individuals. The EDQM, a Directorate of the Council of Europe, created in 1964 is a leading organisation that protects public health by enabling the ... presented the EMA’s views on raw materials for cell-based and gene therapy products and described the legislation in place at a European level ...
Radiation Oncology Clinical Worksheets - Optum
Has the patient previously received radiation therapy to the same or an immediately adjacent area? Yes No Unknown Does the patient have a connective tissue disorder, such as lupus or scleroderma? ... What is the patient’s risk group? Low Risk (PSA <= 10.0, Gleason Score = 6, T1- T2a) Intermediate Risk (PSA > 10.0 < 20.0, Gleason = 7, T2b-T2c)
Prospective risk adjustment and quality services
Prospective risk adjustment and quality services Optum® Prospective Solutions offers pre-visit and point-of-care support to help improve member outcomes. It does so through services that support early detection and ongoing evaluation of chronic conditions for Medicare Advantage (MA), Affordable
Appendix A - Example Risk Assessment proforma for proposed activities ...
Appendix A - Example Risk Assessment proforma for proposed activities involving; Gene Therapy Medicinal Products (GTMPs) or Gene Therapy Investigational Medicinal Products (GTIMPs) Creator: University Hospital of Wales & University Hospitals Bristol & Weston NHS Foundation Trust Document version number: V1.1 Date written: November 2020
Electroconvulsive Therapy (ECT) - Provider Express
22 Aug 2023 · Electroconvulsive therapy (ECT) is a treatment device used for treating severe psychiatric illness by applying a brief intense electrical current to precise locations on the head to induce a seizure that lasts less than one minute.
Behavioral Health Solutions National Network Manual - Provider …
15 Jun 2024 · Optum Emotional Wellbeing Solutions (EWS) is a modern and flexible Employee Assistance Program (EAP) that offers support for everyday life. • Upon completion of EAP services, you may refer for, or begin provision of, most routine outpatient services for clients whose benefits are administered by Optum. •
Shining a light on hidden fees - Optum
4. Tao, J. 2014 Optum re-priced claims Facets. Optum Transplant Value Initiative. Accessed September 29, 2015. Optum adult transplant recipients transplanted 1/1/2014-12/31/2014 with Medicare Advantage insurance. 5. Schmidt, A. 2014 Optum re-priced claims (Facets), 2014 Cost Report D-4 data. Retrieved Jun 3, 2015. Billed charges stated in 2015 ...
A Drug-Tunable Gene Therapy for Broad-Spectrum Protection …
Original Article A Drug-Tunable Gene Therapy for Broad-Spectrum Protection against Retinal Degeneration Clayton P. Santiago, 1Casey J. Keuthan, Sanford L. Boye, 1Shannon E. Boye, Aisha A. Imam, and John D. Ash 1Department of Ophthalmology, University of Florida, Gainesville, FL, USA Retinal degenerations are a large cluster of diseases character-
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This handbook is being issued to provide procedures and instructions for administering the Livestock Risk Protection Plan of Insurance for the 2025 and succeeding crop years. This handbook replaces FCIC-20010-2, Livestock Risk Protection (LRP) Handbook, dated March 5, 2024. This handbook is effective upon approval for
March 2022 - OptumRx
The Optum Rx Business Committee meets monthly to evaluate tier placements and new prescription products approved by the Food and Drug Administration (FDA). This committee makes decisions based on information ... • Through our ongoing Generic First initiative, new Step Therapy will be required for nine drugs which have more cost- effective ...
Symmetry Pharmacy Risk Groups - Optum
Symmetry Pharmacy Risk Groups A pharmacy-based approach to cost risk assessment optum.com Assessment of member cost risk is a critical need of health care organizations. Health plans and other managed care organizations are increasingly adopting tools that allow them to better understand and predict cost risks of the members they enroll,
Symmetry Procedure Episode Groups - Optum
For example, newer policies have shifted financial risk to hospitals by holding them accountable for the additional costs associated with complications. In addition, bundled payment initiatives — where providers receive a single, fixed payment for many of the services within the episode — are becoming an increasingly popular form of value-
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139 or drafted, by the EMEA, CHMP and its working parties in areas of gene therapy, cell therapy and 140 tissue engineering, as well as pharmacovigilance and risk management. 141 Figure 1 Scope of the guideline MP in scope of Directive 2001/83/EC Medicinal products (MP) Medical devices Advanced therapy MP (ATMP) Somatic cell therapy MP Gene ...
Step therapy — Premium - OptumRx
Step therapy requirements are effective as of July 1, 2020. The list of step therapy medications is subject to change without notice. Step therapy requirements may vary by benefit plan. Additional clinical programs for the medications above may affect your prescription drug coverage. These programs may include quantity limits and prior ...
JULY 2023 Accessing Cell and Gene Therapies - Manatt
gene or introduce a new copy of a gene; different types of gene therapy include gene addition, silencing, reprogramming or elimination. 5 Once a therapy gains FDA approval, a patient’s journey typically involves (1) an assessment of eligibility, risks and benefits of a particular therapy, (2) insurance coverage authorization, (3) preparation ...
