Health Care Management and the Law: Principles and Applications
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Health Care Management and the Law: Principles and Applications engages students who will be leading and shaping twenty-first century health care organizations. It raises questions about health law issues such as emergence of the U.S. as a player in the global health care industry, innovative new approaches to the payer/provider model, and the future of tailored therapeutics. The text provides a comprehensive overview of health law, which is relevant to both undergraduate students seeking the basic management skills required to work in health care organizations, and graduate students currently working in health care organizations. The text is divided into thirteen broad parts ranging from an overview of specific health laws and affordable health care to producers of medical products and the future of health care in the U.S. Health Care Management and the Law concludes with a summary of improved medical technologies and the future of personalized health care. The technology-enhanced learning tools that accompany the text are available in multiple formats to fit individual readers' learning preferences, including an online learning management system with a test generator, study notes, Web links, threaded discussion forums, and additional assignments; an instructor's resource CD with PowerPoint presentations, Exam View? test bank, instructor's manual, and syllabus templates; and a student study guide. An online companion to this text offers additional student and instructor resources including summaries of specific court decisions recently decided, as well as the full decisions, and additional data-driven facts from the text. The range of instructional tools will meet virtually every instructors' needs. Cover Page Title Page Copyright Page Contents Preface Reviewers How To Use This Text Part I: Introduction CHAPTER 1: Processes for Thinking About the U.S. Health Care System In Brief Fact or Fiction Principles and Applications “New” Approach to Health Care Neurology of Internal Patterns Test Mental Models World of Constant Change and Evolution “Adaptive Disconnects” Support of “Old” Mental Models Zooming-In and Zooming-Out Process of Making Sense of Things Practical Implications of the “New” Neuroscience Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 2: Introduction to Health Law In Brief Fact or Fiction Principles and Applications The Declaration of Independence U.S. Constitution and Bill of Rights Judicial Branch Legislative Branch Executive Branch Use of Governmental Powers Law Fact Chapter Summary Law Notes Chapter Bibliography Part II: Overview of Specific Health Laws CHAPTER 3: Health Care Compliance Programs In Brief Fact or Fiction Principles and Applications Definition of Health Care Fraud and Abuse Scope of Health Care Fraud Financial Incentives Government Enforcement of Health Care Fraud Laws Compliance Programs Confusion Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 4: Antitrust and Regulation of Health Care Providers In Brief Fact or Fiction Principles and Applications Defensible Theories of Wrongful Conduct Analysis of Competition LN1 Medical Mergers and Acquisitions Specialty Hospitals Nursing Wages Antitrust Litigation Physician Privileges and Credentialing Exclusive Dealing Using Antitrust Laws to Thwart Competition Life-Cycle Management of Drugs Antitrust Compliance Differences in Antitrust Philosophy Law Fact Chapter Summary Law Notes Chapter Bibliography Part III: Access to Health Care CHAPTER 5: Access to and Reimbursement for Medically Necessary Health Care In Brief Principles and Applications Access Challenges Coverage for the Uninsured or Underinsured Economics of the Uninsured and Underinsured Defining Health Risks Health Insurance Risk Pooling Consumer-Directed Health Care v. High Deductible Health Plans Challenges of Access to Health Care Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 6: Medicaid and SCHIP Access to Medically Necessary Health Care In Brief Fact or Fiction Principles and Applications The Three W’s of Medicaid Insurance: Who? What? Why? SCHIP Insurance Why Is Public Health Insurance Economically Necessary? Unaffordability of Advanced Medicine Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 7: Medicare Reforms In Brief Fact or Fiction Principles and Applications Medicare Reform: Financing by Individuals or Society? Complexity of Medicare Structural Reform of Medicare Rationing Treatment Prevalence Overhauling Medicare Law Fact Chapter Summary Law Notes Chapter Bibliography Part IV: Affordable Health Care CHAPTER 8: Mutually Affordable Health Care In Brief Fact or Fiction Principles and Applications Historic Foundation of Tax-Exempt Hospitals Duty of Tax-Exempt Hospitals to Provide Mutually Affordable Health Care Lack of Affordable Health Care The Uninsured and Underinsured: Two Growing Patient Groups Federal, State, and Local Governments at Odds Federal Class-Action Lawsuits State Class-Action Lawsuits Heightened Scrutiny of Charitable Care and Community Benefit Standards Nonprofits Look Similar to For-Profits Discriminatory Pricing State Government Monitoring Responsibilities Tax-Exempt Hospitals Collecting from the Uninsured and Underinsured Who Are Able to Pay Medical and Financial Vulnerabilities Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 9: Patient Rights and Responsibilities In Brief Fact or Fiction Principles and Applications Rights or Privileges Debate Patient Rights Debate Rationing and Cost-Effectiveness Analysis Determinations of Medical Necessity Universal Coverage and the Right to Health Care Debate Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 10: Tort Reform and Reducing the Risk of Malpractice In Brief Fact or Fiction Principles and Applications Publicly Funded Health Care Programs Affect Tort Reform Disruptive Innovation How Medical Malpractice Occurs Malpractice Myths Medical Review Panels Non-Economic Damages Caps Entry and Exit Restrictions for the Liability Insurance Industry Liability Limitations for Innovative and Experimental Medical Treatments Compensation Benchmarks for Malpractice Payouts Redefining Malpractice Administrative Health Courts Law Fact Chapter Summary Law Notes Chapter Bibliography Part V: Development of Human Capital CHAPTER 11: Human Resources Departments In Brief Fact or Fiction Principles and Applications Defining the Role of Human Resources in the Health Industry Business Partnership A Two-Tiered Human Resources System Serving Employees as the Customers Human Resources’ Triple Roles Performance-Based Pay Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 12: Employers’ Health Care Costs In Brief Fact or Fiction Principles and Applications Current Quality and Costs Trends Forget Big Brother Prospective Medicine Preventable Behaviors and Conditions Lifestyle Discrimination and Choices Health Laws Supporting Lifestyle Choices Disclosure Requirement of Lifestyle Choices Lifestyle Discrimination is Good Business Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 13: Labor and Management Relations In Brief Fact or Fiction Principles and Applications Public Perceptions of Labor and Management Myth: Americans Hate Labor Unions Relevance of Labor in the Health Care Industry Nurse Workload Management Other Crucial Issues in Health Care Staffing Recruitment and Rights of Foreign Nurses and Physicians Contingent Employees Need for Comprehensive Legislative Reform Law Fact Chapter Summary Law Notes Chapter Bibliography Part VI: Strategic Health Care Restructurings CHAPTER 14: Trends in Health Care Restructurings In Brief Fact or Fiction Principles and Applications Trends in Health Care Restructuring Health Care Systems Problems Without Solutions Integrated Health Systems Restructured Health Care Programs Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 15: Integration Deals in the Health Care Sector In Brief Fact or Fiction Principles and Applications Competition in Health Care Bankruptcy Restructurings Hospital Bankruptcies Basis of Expectations Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 16: Business Process Outsourcing In Brief Fact or Fiction Principles and Applications Offshoring of Health Care Outsourcing Flattening of the U.S. Health Care System Global Drug Manufacturing in China Early-Stage Medical Products Research in India BPO Privacy Concerns What Lies Ahead for BPOs? Law Fact Chapter Summary Law Notes Chapter Bibliography Part VII: Producers of Medical Products CHAPTER 17: Pharmaceuticals In Brief Fact or Fiction Principles and Applications Overview of the Pharmaceutical Market Global Pricing of Drugs Market Changes: Cost Management Exposure Game FDA Preemption Regulation by Litigation No-Compete Agreements with Generic Manufacturers Vaccines Future Challenges Facing the Pharmaceutical Industry Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 18: Biotechnology and Biopharmaceuticals In Brief Fact or Fiction Principles and Applications Challenges Facing the Biotechnology Industry Global Drug Pricing Drivers of Bioscience Emerging Bioscience Technologies Convergent Technology Emerging Areas of Bioscience Research Pharmaceutical and Biotechnology Repositioning and Restructuring Management of New Scientific Developments Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 19: Medical Devices In Brief Fact or Fiction Principles and Applications Medication Over Surgery Market Growth Direct Marketing to Physicians Pediatric Devices Inspections of Medical Device Manufacturing Facilities Post-Marketing Surveillance State Tort Claims Against Device Manufacturers Use of Medical Devices for Non-medical or Entertainment Purposes Future of the Device Industry Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 20: Health Information Technology In Brief Fact or Fiction Principles and Applications Electronic Health Records Systems Online Control and Management of Medical Information Remote Monitoring and Management of Patients Electronic Medicine Health Space Information Privacy Need for Clarification in an Age of Rapid Technological Change Law Fact Chapter Summary Law Notes Chapter Bibliography Part VIII: Improving the Quality of Health Care CHAPTER 21: Disease Management In Brief Fact or Fiction Principles and Applications Health Care Quality Employer Ambivalence about Health Insurance Emergence of Pay-for-Performance Programs Transparency and Access to Health Information Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 22: Evidence-Based Medicine Fact or Fiction Principles and Applications Definition of Evidence-Based Medicine Failure to Use Evidence-Based Medicine Evidence-Based Medical Principles Widespread Federal Agency for Healthcare Research and Quality Overused, Underused, and Misused Health Care Elimination of Geographic Variations Evolving Medical Advancements and Medical Efficacy Drug Effectiveness Review Project Problems with Authority-Based Medical Opinions The Future of EBM Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 23: Improving Patient Safety and Quality of Health Care In Brief Fact or Fiction Principles and Applications Medical Malpractice Framework National Database for Patient Safety Research Institute of Medicine and Food and Drug Administration Reforms Prevention of Medical Errors and Adverse Events Law Fact Chapter Summary Law Notes Chapter Bibliography Part IX: Our Health Care System’s Response to Illness CHAPTER 24: Human Body Parts Industry In Brief Fact or Fiction Principles and Applications Misconduct in the Human Remains Market General Unawareness of Corruption Commodification of Human Materials Medical Research and Development of Medical Technologies Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 25: Organ and Tissue Procurement and Transplantation In Brief Fact or Fiction Principles and Applications(LN1) Types of Transplantation and Limitations Organ Transplantation Tissue Transplantation Xenotransplantation Alternative Strategies for Developing Organ and Tissue Replacements Moving Altruism Forward Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 26: HIV/AIDS Pandemic In Brief Fact or Fiction Principles and Applications Leading Communicable Disease Killer Worldwide The Dual Role of Governments and the Global Pharmaceutical Industry The Fight Against HIV/AIDS in the U.S. The Global Blood Supply Lack of Access to Health Care The Global HIV/AIDS Crisis and Pharmaceuticals The Unrelenting Stigma of AIDS The Second Wave of HIV/AIDS Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 27: Mental Heath In Brief Fact or Fiction Principles and Applications Key Terms Epidemiology of Mental Illness Mental Illness Within Specific Populations Intellectually Disabled Involuntary Civil Commitments Protection and Advocacy for Individuals with Mental Illness Sex Addiction and Human Trafficking for the Purpose of Sexual Exploitation Sex Addiction and Internet Pornography Bibliotherapy Law Fact Chapter Summary Law Notes Chapter Bibliography Part X: End-of-Life Health Care CHAPTER 28: Hospice Care In Brief Fact or Fiction Principles and Applications Demographics of Life and Death Overview of Hospice Care State Licensing Regulations Hospice’s Financing Structure Growth Industry Conflicting Perspectives Health Care Decision Laws Emerging Industry Consolidation Prevention Versus Add-On Costs Perinatal Hospice Medical Futility Pre-Hospice Palliative Care Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 29: Mature Minor Rights to Refuse Life-Sustaining Medical Treatment In Brief Fact or Fiction Principles and Applications Parental Autonomy Criteria for Determining Maturity of Minors Common Law Principle of Self-Determination Right to Refuse Life-Sustaining Medical Treatment Withdrawal of Life-Sustaining Medical Treatment Words of Caution for Health Care Providers Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 30: Care of the Critically Ill and Dying In Brief Fact or Fiction Principles and Applications Right-to-Die Palliative Sedation Assisted Dying Law Fact Chapter Summary Law Notes Chapter Bibliography Part XI: Our Health Care System’s Response to New Technologies CHAPTER 31: Stem Cells and Regenerative Medicine* In Brief Fact or Fiction Principles and Applications Stem Cells Regenerative Medicine Moral Issues and Public Sensitivities Funding of Stem Cell Research Intellectual Property Rights of Stem Cells Moving Forward with Innovative Medical Technologies Law Fact Chapter Summary Law Notes Chapter Bibliography Note CHAPTER 32: Reprogenics and Assisted Reproductive Technology Experimentation In Brief Fact or Fiction Principles and Applications Chimera Technology Synthetic Biology Ban on Patenting Human Organisms Gene Patents The Future of Reproductive Medicine and Genetics Law Fact Chapter Summary Law Notes Chapter Bibliography Part XII: Additional Pressing Issues Facing Our Health Care System CHAPTER 33: Global Pandemics and Public Health Emergency Threats In Brief Fact or Fiction Principles and Applications Potential Dangers to Public Health Operating in a Context of Turmoil The Basics About Public Health Emergency Threats Emergency Preparedness Plans Business Continuity Management Low Probability, High Impact Events Integrating Pandemic Threats Into Business Strategy Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 34: Health Care Issues For Women In Brief Fact or Fiction Principles and Applications Health Risks of Women and Children Reproductive Health Wrongful Life, Birth, and Pregnancy Abortions Sexually Transmitted Infections Medical Products Industry Economic Impact of Failing to Prioritize Women’s Health Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 35: Clinical Trials In Brief Fact or Fiction Principles and Applications Research and Development Investments Fund a Complex Multistage Pathway Clinical Trials of Generic Drugs Health Risk Assessments Expanded Access Protocols Termination of Clinical Trials Observational Studies International Clinical Trials Informed Consent in General Transparency and Full Disclosure in Clinical Testing Financial Conflicts of Interest Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 36: Food Safety In Brief Fact or Fiction Principles and Applications Distinction or Similarity Between the Food and Tobacco Industries Healthy Versus Unhealthy Foods Fragmented Regulatory System Food Marketing and Advertising Functional Foods Food Labeling Laws McLawsuits and Cheeseburger Legislation Food Advertising to Children Healthy Options and Nutraceutical Advertising Voluntary Marketing Guidelines Food Industry and Public Health Sector Viewpoints Regulation of Trans-Fats Genetically Modified Foods Food Additives and Contaminants Emerging Issues Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 37: Environmental Safety In Brief Fact or Fiction Principles and Applications Background and Context Second Amendment Jurisprudence The Epidemiology of Gun Violence Premium Adjustments in Health Benefit Plans Law Fact Chapter Summary Law Notes Chapter Bibliography CHAPTER 38: Prevention of Child Abuse and Neglect In Brief Fact or Fiction Principles and Applications Incidence of Maltreatment Characteristics of Child Abuse and Neglect Survival-Threatening Syndromes and Injuries Survival-Threatening Neglect A Different Problem: Adolescent Cosmetic Surgery Termination of Parental Rights Child Abuse Reporting Laws Law Fact Chapter Summary Law Notes Chapter Bibliography Part XIII: Conclusion CHAPTER 39: Future Prospects: Health Care Management and the Law In Brief Fact or Fiction Principles and Applications The Health Care Crisis Within the U.S.’s Legal Framework Our Approach Our Future: Personalized Health Care Law Fact Chapter Summary Law Notes Chapter Bibliography Appendix A: The Declaration of Independence Appendix B: The Constitution of the United States Appendix C: Abbreviations and Acronyms Glossary Index
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