Health Care Management and the Law: Principles and Applications

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