Debating Modern Medical Technologies.

By: Maschke, Karen JContributor(s): Gusmano, Michael KMaterial type: TextTextSeries: eBooks on DemandPublisher: Santa Barbara : ABC-CLIO, LLC, 2018Copyright date: ©2018Description: 1 online resource (226 pages)Content type: text Media type: computer Carrier type: online resourceISBN: 9781440861901Subject(s): Medical technology-Politcal aspects | Medical technology-Safety measures | Medical technology-Social aspectsGenre/Form: Electronic books.Additional physical formats: Print version:: Debating Modern Medical Technologies: the Politics of Safety, Effectiveness, and Patient AccessDDC classification: 610.28/9 LOC classification: R855.3 .M373 2018Online resources: Click here to view this ebook.
Contents:
Cover -- Title -- Copyright -- Contents -- Acknowledgments -- Chapter 1: Evidence, Politics, and Medical Care Technology -- Chapter 2: Evolving Public- and Private-Payer Approaches to Evidence and Health Technology Assessment -- Evidence and the Influence of Scientific Medicine -- From Cost Crisis to Value for Money -- Expanding the Federal Government's Role in Health Technology Assessment -- Political Attacks on Health Services Research -- Renewed Enthusiasm for Comparative Effectiveness Research -- Medicare's Renewed Interest in Evidence of Effectiveness -- Evidence of Value for Private Payers -- Conclusion -- Chapter 3: Mammography Screening: Vested Interests and Polarization -- Breast Cancer Trends in the United States -- Breast Cancer Advocacy and the Role of Mammography Screening -- Mammography Screening -- Concerns About Underuse and Overuse of Screening -- The 2009 Mammography Screening Recommendations -- The Problem with Disinvestment -- Mammography and the Limited Focus of Breast Cancer Advocacy -- The Limits and Politics of Weighting Risks -- Obamacare, Rationing, and Hyperpartisanship -- Conclusion -- Chapter 4: When Medicare Said No for Amyloid PET Imaging -- Imaging the Brain for Amyloid Plaque -- Asking for CMS Coverage -- CMS Decision-Making and Coverage Criteria -- Coverage Criteria and the NCD Approach -- The CED Pathway -- The NCD for Amyloid PET Imaging -- Advocacy Positions Regarding Amyloid PET Coverage -- The NCD Outcome -- Responses to the Final Decision -- The IDEAS Study -- Conclusion -- Chapter 5: Placing a Value on Cure: Lessons from the New Generation of Hepatitis C Drugs -- Incidence and Consequences of Hepatitis C -- What Is Hepatitis C? -- How Many People Are Infected with Hepatitis C? -- What Are the Characteristics of People Who Are Infected? -- Evolution of Hepatitis C Treatment.
Public- and Private-Payer Coverage Policies -- Implications for Health Care Spending -- The Advocacy Campaign for Expanded Access -- A Response to Stigmatized Patients? -- Role of the Courts -- Price Negotiation and Competition -- Lessons from the New Generation of Hepatitis C Drugs -- Drug Company Responses to Price Complaints -- How to Evaluate Value in the Context of Cure? -- Loss of Innovation -- Conclusion -- Chapter 6: Avastin and the Politics of Accelerated Approval -- The Challenge of Treating Advanced Breast Cancer -- Drug Regulation in the United States: From Caveat Emptor to Accelerated Approval -- Progressive Era Reforms -- The Food, Drug, and Cosmetic Act of 1938 -- The 1962 Kefauver-Harris Drug Amendments -- Expedited Approval and Expanded Access -- Conditional Approval to Use Avastin for Treating Advanced Breast Cancer -- Reversing Course -- June 2011 FDA Hearing -- Conclusions: Avastin and the Push for Faster Approval -- Chapter 7: The Path to the Clinic for Stem Cell and Other Regenerative Medicine Interventions -- FDA Regulation of Cellular Products -- The 2001 Rule -- FDA's Initial Enforcement Actions -- FDA Clarifies the Regulatory Approach -- Stem Cells and Right-to-Try Laws -- Right-to-Try in the States -- Right-to-Try in Congress -- Regenerative Medicine and the 21st Century Cures Act -- Conflicting Interest Group Positions -- From REGROW to the Cures Act -- The New Political and Regulatory Landscape -- Gottlieb's First Steps -- FDA's New Policy Framework -- Conclusion -- Chapter 8: Conclusion: The 21st Century Cures Act and the Future of Health Technology Assessment -- The Importance of Framing in Scientific Disputes -- Who Should Have the Power to Decide? -- Complex Coalitions and Competition among Powerful Interest Groups -- Paying for Technology and Disagreements about Public Priorities -- Final Reflections.
Public Engagement -- Access to Postapproval Data -- Public and Private Payer Transparency -- Looking Forward -- Notes -- Bibliography -- Index -- About the Authors.
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Cover -- Title -- Copyright -- Contents -- Acknowledgments -- Chapter 1: Evidence, Politics, and Medical Care Technology -- Chapter 2: Evolving Public- and Private-Payer Approaches to Evidence and Health Technology Assessment -- Evidence and the Influence of Scientific Medicine -- From Cost Crisis to Value for Money -- Expanding the Federal Government's Role in Health Technology Assessment -- Political Attacks on Health Services Research -- Renewed Enthusiasm for Comparative Effectiveness Research -- Medicare's Renewed Interest in Evidence of Effectiveness -- Evidence of Value for Private Payers -- Conclusion -- Chapter 3: Mammography Screening: Vested Interests and Polarization -- Breast Cancer Trends in the United States -- Breast Cancer Advocacy and the Role of Mammography Screening -- Mammography Screening -- Concerns About Underuse and Overuse of Screening -- The 2009 Mammography Screening Recommendations -- The Problem with Disinvestment -- Mammography and the Limited Focus of Breast Cancer Advocacy -- The Limits and Politics of Weighting Risks -- Obamacare, Rationing, and Hyperpartisanship -- Conclusion -- Chapter 4: When Medicare Said No for Amyloid PET Imaging -- Imaging the Brain for Amyloid Plaque -- Asking for CMS Coverage -- CMS Decision-Making and Coverage Criteria -- Coverage Criteria and the NCD Approach -- The CED Pathway -- The NCD for Amyloid PET Imaging -- Advocacy Positions Regarding Amyloid PET Coverage -- The NCD Outcome -- Responses to the Final Decision -- The IDEAS Study -- Conclusion -- Chapter 5: Placing a Value on Cure: Lessons from the New Generation of Hepatitis C Drugs -- Incidence and Consequences of Hepatitis C -- What Is Hepatitis C? -- How Many People Are Infected with Hepatitis C? -- What Are the Characteristics of People Who Are Infected? -- Evolution of Hepatitis C Treatment.

Public- and Private-Payer Coverage Policies -- Implications for Health Care Spending -- The Advocacy Campaign for Expanded Access -- A Response to Stigmatized Patients? -- Role of the Courts -- Price Negotiation and Competition -- Lessons from the New Generation of Hepatitis C Drugs -- Drug Company Responses to Price Complaints -- How to Evaluate Value in the Context of Cure? -- Loss of Innovation -- Conclusion -- Chapter 6: Avastin and the Politics of Accelerated Approval -- The Challenge of Treating Advanced Breast Cancer -- Drug Regulation in the United States: From Caveat Emptor to Accelerated Approval -- Progressive Era Reforms -- The Food, Drug, and Cosmetic Act of 1938 -- The 1962 Kefauver-Harris Drug Amendments -- Expedited Approval and Expanded Access -- Conditional Approval to Use Avastin for Treating Advanced Breast Cancer -- Reversing Course -- June 2011 FDA Hearing -- Conclusions: Avastin and the Push for Faster Approval -- Chapter 7: The Path to the Clinic for Stem Cell and Other Regenerative Medicine Interventions -- FDA Regulation of Cellular Products -- The 2001 Rule -- FDA's Initial Enforcement Actions -- FDA Clarifies the Regulatory Approach -- Stem Cells and Right-to-Try Laws -- Right-to-Try in the States -- Right-to-Try in Congress -- Regenerative Medicine and the 21st Century Cures Act -- Conflicting Interest Group Positions -- From REGROW to the Cures Act -- The New Political and Regulatory Landscape -- Gottlieb's First Steps -- FDA's New Policy Framework -- Conclusion -- Chapter 8: Conclusion: The 21st Century Cures Act and the Future of Health Technology Assessment -- The Importance of Framing in Scientific Disputes -- Who Should Have the Power to Decide? -- Complex Coalitions and Competition among Powerful Interest Groups -- Paying for Technology and Disagreements about Public Priorities -- Final Reflections.

Public Engagement -- Access to Postapproval Data -- Public and Private Payer Transparency -- Looking Forward -- Notes -- Bibliography -- Index -- About the Authors.

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Reviews provided by Syndetics

CHOICE Review

Maschke (Hastings Center) and Gusmano (Rutgers Univ.) provide a well-rounded and expertly researched guide exploring medical technology. This book focuses on the intersection of economics, policy, and the public interest with regard to medical devices, drugs, and tests. The text is divided into eight chapters, each of which examines a particular facet of this broad field, including new drug treatments for hepatitis C, stem cell research and applications, and mammography recommendations. In each case, the issue is explored with regard to how conflicting factors complicate the health technology environment. Conflicting factors include values and morals held by various groups, economic costs and incentives for research and implementation, and public policy considerations. Throughout the book Maschke emphasizes the challenges of the current US health insurance system. This work could be of interest to students in a number of fields, as it explores healthcare, public policy, and economics. A curated bibliography provides useful directions for further study. Summing Up: Recommended. Undergraduates and graduate students. --Kristin Jan Whitehair, independent scholar

Author notes provided by Syndetics

Karen J. Maschke is research scholar at the Hastings Center with expertise on the ethical, legal, and policy issues associated with new biomedical technologies. She is editor of IRB: Ethics & Human Research .

Michael K. Gusmano is associate professor of health policy at Rutgers University and research scholar at the Hastings Center with expertise on the politics of health reform, comparative politics, and health technology assessment.

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