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The Value of Laboratory Screening and Diagnostic Tests for Prevention and Health Care Improvement

September 2009

American Clinical Laboratory Association; Advanced Medical Technology Association (AdvaMed)
Lewin contact: Clifford Goodman

The contributions of clinical laboratory screening and diagnostic tests to health care quality and outcomes are substantial. These contributions were described in an earlier report from The Lewin Group, The Value of Diagnostics Innovation, Adoption, and Diffusion in Health Care (2005). This report updates key elements of that study, providing a current overview of the important role of laboratory screening and diagnostic tests in our health care system, today’s means of assessing value, and four case studies documenting value of specific tests to patient care.

Client Area: Associations
Expertise Area: Evidence-Based Medicine / HTA

Laboratory Medicine: A National Status Report

May 2008

DHHS, Centers for Disease Control and Prevention (CDC)
Lewin contact: Clifford Goodman

This report, commissioned by the Centers for Disease Control and Prevention  provides a detailed overview of the key factors affecting the laboratory medicine sector. It is intended that the report serve as a point of reference for measuring and improving quality in the future as well as for policy guidance to professional organizations, government agencies, and others who provide, use, regulate, and pay for laboratory services.

Client Area: Federal Government
Expertise Area: Evidence-Based Medicine / HTA

Assessing the Costs of Performing DXA Services in the Office-based Setting : Final Report

October 2007

American Association of Clinical Endocrinologists, International Society for Clinical Densitometry, The Endocrine Society, American College of Rheumatology

Osteoporosis is a disease that is characterized by low bone mass and a deterioration of bone structure that results in bone fragility and an increased risk of fracture. The disease affects 10 million older Americans and is associated with significant mortality and morbidity. An additional 34 million individuals have osteopenia (low bone mass) and are at increased risk of fracture at some time in their lives. Osteoporosis-related fractures represent a serious illness burden and are a major cause of disability among Medicare beneficiaries. Dual-energy X-ray absorptiometry (DXA) is the “gold standard” for diagnosing osteoporosis, using World Health Organization criteria. Amid recent changes in Medicare reimbursement methodology, providers had become concerned that payment for DXA and vertebral fracture assessment (VFA) was below operating costs. However, a systematic study of the cost to perform a DXA procedure had not been conducted. The American Association of Clinical Endocrinologists, the International Society for Clinical Densitometry, The Endocrine Society and the American College of Rheumatology commissioned The Lewin Group to survey office-based providers of DXA, in order to develop estimates of the costs associated with providing DXA services to Medicare beneficiaries. This study should assist policymakers and others to determine whether the current Medicare reimbursement for DXA approximates real world operating costs.

Client Area: Associations
Expertise Area: Evidence-Based Medicine / HTA, Medicare

State Impacts of the Medical Technology Industry

October 2007

Advanced Medical Technology Association (AdvaMed)

This report, prepared for the Advanced Medical Technology Association (AdvaMed), presents estimates of the economic contributions of the Medical Technology Industry (MTI) to each of the 50 states and the District of Columbia. This includes 2006 estimates for each state of MTI employment, payrolls, and sales/shipments and of the multiplier economic effects on these same measures.

Client Area: Associations
Expertise Area: Evidence-Based Medicine / HTA

Personalized Health Care Expert Panel Meeting: Summary Report

September 2007

DHHS, Office of the Assistant Secretary for Planning and Evaluation (ASPE)
Lewin contact: Clifford Goodman

The concept of personalized health care (PHC) has attracted considerable scientific, medical, commercial and policy interest for its potential to sharpen the focus of health care and improve its effectiveness and efficiency. As part of a broader vision of advancing and leveraging medical research to improve and transform health care in the US, the Secretary of the US Department of Health and Human Services (DHHS) has identified personalized health care as one of the Department’s top 10 priorities. The Office of the Assistant Secretary for Planning and Evaluation commissioned The Lewin Group to convene a PHC Expert Panel to provide input to the Office of the Secretary, DHHS, toward realizing the integration of PHC into clinical and public health practice. During the meeting the panel considered and discussed five main issues pertaining to the integration of PHC into clinical and public health practice: Demonstrating clinical validity and utility of PHC; Demonstrating value/cost-effectiveness of PHC Identifying the role of PHC in reducing health disparities Educating and engaging providers and patients about PHC; and Using databases to build evidence and inform decisions in PHC. The report summarizes key observations that emerged from the Expert Panel’s discussion of these five main issues.

Client Area: Federal Government
Expertise Area: Evidence-Based Medicine / HTA

Cost-effectiveness Considerations in the Approval and Adoption of New Health Technologies: Final Report and Case Studies

January 2007

DHHS, Office of the Assistant Secretary for Planning and Evaluation (ASPE)
Lewin contact: Clifford Goodman

The Office of the Assistant Secretary for Planning and Evaluation commissioned The Lewin Group to determine how and to what extent cost-effectiveness (CE) considerations are incorporated in the approval and adoption of new health technologies and the implications of not incorporating such considerations. This report examines the use of CE and other cost-health tradeoff evidence by federal and nonfederal health stakeholders, paying particular attention to the scope of authority, range and/or circumstances of use, and responsibilities for regulating CE and other economic information by the Food and Drug Administration. The role of economic evidence in decision-making also is explored in case studies of four contemporary health technologies: nucleic acid testing, Relenza (zanamivir), drug-eluting stents, and implantable cardioverter-defibrillators.

Client Area: Federal Government
Expertise Area: Evidence-Based Medicine / HTA

What is known about the effectiveness of economic instruments to reduce consumption of foods high in saturated fat and other energy-dense foods for preventing and treating obesity?

July 2006

World Health Organization
Lewin contact: Clifford Goodman

This paper, prepared for the Health Evidence Network of the World Health Organization, synthesizes the evidence pertaining to what is known about the effectiveness of economic instruments to reduce consumption of foods high in saturated fats and other energy-dense foods for preventing and treating obesity. The review found no direct scientific evidence of a causal relationship between policy-related economic instruments and food consumption, including foods high in saturated fats. Indirect evidence suggests that such a causal relationship is plausible, though it remains to be demonstrated by rigorous studies in community settings. Modeling analyses suggest that a combination of increased prices (in the form of taxes) for such nutrients as fat, saturated fat and sugar and subsidies on fibres could reduce consumption of the taxed nutrients, as well as total energy intake. Studies of tax and price policies applied to tobacco and alcohol products may serve as models for lowering consumption of energy-dense foods, but critical differences among these types of interventions may limit their generalizability to food consumption. The paper also addressed considerations for future policy and research.

Expertise Area: Evidence-Based Medicine / HTA

An Evidence-Based Study of the Role of Dietary Supplements in Helping Seniors Maintain Their Independence

January 2006

Dietary Supplement Education Alliance

The Lewin Group was commissioned by the Dietary Supplement Education Alliance to (1) critically review the research literature for two dietary supplements for which an association has been shown between intake of the supplement and reduced risk of a disease that can lead to a loss of an older person's independence, and (2) develop estimates of potential health care savings that could result from daily use of the supplement. Supplement/disease combinations in this study are omega-3 fatty acids and coronary heart disease, and lutein/zeaxanthin and age-related macular degeneration.

Client Area: Associations
Expertise Area: Evidence-Based Medicine / HTA

How Effective Would Antiviral Vaccination and Antiviral Drug Prevention and Treatment Strategies Be for Reducing the Impact of the Next Influenza Pandemic?

January 2006

World Health Organization
Lewin contact: Clifford Goodman

An influenza pandemic seems inevitable. The H5N1 influenza virus, known as the avian influenza, is currently circulating in Asia and has appeared in other regions. Avian influenza (flu), which has been transmitted from birds to humans on a limited basis, can be rapidly fatal, with a reported death rate of at least 50% in the documented human cases to date. If a human-to-human transmissible form emerges and spreads rapidly, it will pose a great threat to global public health, although the mortality rate may not be as high as that observed thus far. While various factors suggest that this strain could be the cause of the next pandemic, it is unknown when it will occur, whether it will be caused by H5N1 or another new virus or how severe it will be. This report, prepared for the World Health Organization Health Evidence Network, assembles and presents evidence on the potential effectiveness of antiviral vaccination and antiviral drug prevention and treatment for reducing the impact of an influenza pandemic caused by the avian flu virus or another viral strain.

Expertise Area: Evidence-Based Medicine / HTA

The Hospital Built Environment: What Role Might Funders of Health Services Research Play?

August 2005

DHHS, Agency for Healthcare Research and Quality (AHRQ)
Lewin contact: Clifford Goodman

Several noteworthy reports that have been released in the past few years raise troubling concerns about the quality and safety of health care in the United States. Many factors may contribute to the shortfalls in quality, including the way care is delivered and the adequacy of the facility within which that care takes place. A body of evidence is developing about how attributes of the various environments in which health care is provided mediate health care quality. Consistent with the growing movement to apply clinical evidence-based approaches to improve patient outcomes, hospital administrators and researchers also are placing greater emphasis on "evidence-based design" to support and facilitate clinical advances in the field. This is a process for creating hospital environments that is informed by the best available evidence concerning how the physical environment can affect patient outcomes, patient safety and satisfaction, and hospital staff safety and satisfaction. However, the field is relatively new, evidence supporting this approach is not yet robust in many areas and existing research on evidence-based hospital design is not widely known among policymakers, regulators and other decision makers and opinion leaders. This environmental scan is intended to assess what is and is not known about the relationships between hospital design and construction—the built environment—and patient outcomes and satisfaction, and staff working conditions. It discusses the following issues: What is currently driving the market for hospital design and construction? To what extent are hospitals requesting evidence-based designs? What is the research base for the hospital built environment? What are major challenges in building the field of evidence-based hospital design? What are the major gaps in current research and relevant areas of future focus? What are appropriate roles for funders of health services research interested in furthering improvements within the built environment?

Client Area: Federal Government
Expertise Area: Evidence-Based Medicine / HTA

The Value of Diagnostics: Innovation, Adoption and Diffusion into Health Care

July 2005

Advanced Medical Technology Association (AdvaMed)
Lewin contact: Clifford Goodman

The Lewin Group was commissioned by The Advanced Medical Technology Association (AdvaMed) to examine certain key aspects of the US diagnostics industry. This document is intended to: a) educate and inform various audiences about diagnostics and the industry that develops them; b) describe the value of diagnostics through the health care continuum and the broader health system; c) describe the technology evolution in diagnostics and potential of these technologies to alter clinical practice; d) identify and describe the hurdles to product development and dissemination; e) identify changes necessary to overcome these challenges; and f) define actionable recommendations for enabling clinicians, patients, provider institutions, payers and other stakeholders to better realize the value and potential of diagnostics to improve health care delivery, individual health and the public’s health.

Client Area: Associations
Expertise Area: Evidence-Based Medicine / HTA

Ensuring Blood Safety and Availability in the U.S.: Technological Advances, Costs, and Challenges to Payment

September 2002

Advanced Medical Technology Association (AdvaMed)
Lewin contact: Clifford Goodman

The Lewin Group was commissioned by The Advanced Medical Technology Association (AdvaMed) to examine certain key aspects of the U.S. blood collection and distribution processes. In particular, this study examined the role of technological improvements in ensuring blood safety and the ability of the third-party reimbursement system to capture and account for increased costs of blood products and related services.

Client Area: Associations
Expertise Area: Evidence-Based Medicine / HTA

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