The Medical-Legal Aspects of Acute Care Medicine : A Resource for Clinicians, Administrators, and Risk Managers

Preface Author’s Note and Disclaimers Contents Contributors Chapter 1: Morality, Ethics, the Foundations of the American Legal System, and Ethical Challenges in the Digital Age Cultural Norms, Morality, Ethics, and the Law Ethics and the Law Professionalism and Professional Ethics in Medicine Humanism in the Health Sciences The Principles of Biomedical Ethics The Principle of Respect for Autonomy: Consent, Refusal, and Right to Die The Principle of Beneficence and the Fiduciary Duty The Principle of Nonmaleficence and “Primum non Nocere” The Principle of Justice and the Equitable Distribution of Resources Clinical Ethical Challenges and Ethics Committees Moral Distress in Clinical Care The Challenges of Biomedical Ethics in the Technological and Digital Age The Ethics of Practical Wisdom Conclusion References Chapter 2: Traditional and Applied Clinical Ethics: Contemporary and Evolving Challenges Ethical Versus Legal Decision-Making Informed Consent Surrogate Decision-Making Parental Authority and Pediatric Patient Advocacy Ethical Issues Regarding the Patient Who Has Attempted Suicide Death Rationing Care in the ICU Moral Distress References Chapter 3: The Ethics and Laws Governing Informed Decision-Making in Healthcare: Informed Consent, Refusal, and Discussions Regarding Resuscitation and Life-Sustaining Treatment Autonomy and Free Will: The Ethical and Moral Basis of Informed Decision-Making Informed Consent as Shared Decision-Making Autonomy as a Legal Construct: The History of the Informed Consent Doctrine in the USA General Exceptions to the Disclosure Mandate During Informed Consent The Provider as Fiduciary Legal Cause of Action for Failure to Obtain Informed Consent Recent Case Law Impacting Informed Consent Informed Decision-Making as a Regulatory Mandate Informed Consent and Human Subject Research Implied Consent Informed Consent of Minors Against Medical Advice and Refusal to Consent: Legal Pitfalls Informed Refusal and the Right to Die The Disenfranchised: Time for Circumstantial Reevaluation of Paternalism? Summary and Conclusions References Chapter 4: The Laws and Regulations Governing Hospitals and Healthcare Entities Introduction The First Hospitals State Regulation of Hospitals and Healthcare Facilities The Joint Commission (on Accreditation of Healthcare Organizations) Classification of Healthcare Institutions Critical Access Hospitals Acute Care Hospitals Long-Term Care Facilities Federal Oversight: CMS (Medicare and Medicaid) A Brief Overview of Medicare A Brief Overview of Medicaid The Centers for Medicare & Medicaid Services (CMS) Key Federal Regulations Affecting Acute Care Facilities Constitutional Authority over Healthcare Administrative Procedure Law: Agency Structure and Function Diagnosis-Related Groups and the Prospective Payment System Hospital Readmissions Reduction Program (HRRP) The Hospital Value-Based Purchasing (VBP) Program The Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 Hospital-Acquired Condition (HAC) Reduction Programs Patient Safety and Quality Improvement Act (PSQIA) of 2005 Compliance with Healthcare Regulations Antitrust The Emergency Medical Treatment and Active Labor Act Federal Taxation Status of Hospitals Healthcare Entity Organization The Healthcare Board of Directors (Board) Administration and Executives The Medical Staff Conclusion References Chapter 5: The Timeline of a Medical Malpractice Lawsuit Introduction The Cause of Action The Statute of Limitations Pretrial Process Consultation and Informal Fact Acquisition Legal Foundations Preparation Discovery Trial Judge, Jury Selection, and Juries Post-Trial Conclusions References Chapter 6: Regulation of Provider Practice: State Oversight, Licensing, Credentialing, Peer Review, and the National Practitioner Data Bank Licensing of Healthcare Professionals State Board Oversight of Medical Practice Unauthorized Practice of Medicine Unauthorized Practice of Nursing The Process of Disciplinary Actions of State Medical (and Nursing Boards) The Complaint Process The Process of Disciplinary Boards Scope of Practice Provider Credentialing and Privileging Hospital Staff Credentialing Hospital Staff Privileging Peer Review The National Practitioner Data Bank Appendix: Professional Misconduct as Defined By New York State New York State Education § 6530: Definitions of Professional Misconduct [53] Rules of the Board of Regents: Part 29 – Unprofessional Conduct [54] References Chapter 7: Laws and Liability Relating to the Education and Supervision of Trainees and Allied Health Professionals Medical Education The History of Medical Education in the USA Liability for Medical Students and Medical Student Liability Malpractice Liability in Graduate Medical Education Due Process in Medical Education and Discipline Malpractice Liability in Nursing Education and Practice The Captain of the Ship Doctrine Scope of Practice Liability Issues Arising from Preceptorship and Proctoring References Chapter 8: The Science of Teamwork in Healthcare: Importance to Patient Outcome Introduction The Transformation of Healthcare: From Cottage Industry Artisans to Multidisciplinary Teams Risk Management Versus Quality Assurance General Systems Theory Culture and Safety in Healthcare The High Reliability Organization Crew Resource Management Teamwork The Importance of Leadership Summary and Conclusions References Chapter 9: Medical Error, Quality Management, and the Evolving Culture of Safety Medical Error Historical Perspectives on Medical Errors Definitions of Medical Error Legal Implications of Medical Error Responding to an Adverse Event That Causes Patient Harm Quality Management Patient Safety Conclusions References Chapter 10: Laws Pertaining to Insurance and Risk Management Definitions and History of Insurance in the USA The Law of Insurance Types of Professional Liability Insurance Clause Caveats in Professional Liability Insurance Misrepresentations All-Risk Policies Exclusions Duty-to-Cooperate Clause Consent-to-Settle Clause The “Hammer Clause” Defense Costs Incident Reporting/Duty to Notify The National Practitioner Data Bank Alternatives to Traditional Insurance Providers Medical Malpractice Insurance Limits and Excess Verdicts Umbrella Insurance Policies Officers’ and Directors’ Insurance References Chapter 11: Overview of the Claims Submission, Medical Billing, and Revenue Cycle Management Processes Claim Submission The Medical Billing and Revenue Cycle Management Processes Patient Scheduling, Registration, and Insurance Verification Check-In, Co-payments, and Deductible Collection at Time of Service Patient Exam and Physician Documentation Coding and Charge Entry ICD-10-CM Coding HCPCS/CPT Coding Capturing All Services and Physician Fees Managed Care and Insurance Contract Rules Claim Review and Clearinghouse Edits Claim Submission Payment Posting Denial Management and Appeals A/R Follow-Up and Collections Patient Statements RCM Optimization Outsourcing RCM Tips for Successful Claim Submission and Overall RCM References Chapter 12: Regulations and Regulatory Compliance: False Claims Act, Kickback and Stark Laws, and HIPAA Introduction Medicare Fraud and Abuse in General Institutional Compliance and Compliance Plans Documentation The Federal False Claims Act Recent Examples of FEFCA Enforcement Actions Recovery Audit Contractors Anti-Kickback and Stark Recent Examples of AKS and Stark Enforcement Actions Privacy of Protected Health Information: HIPAA Recent Examples of HIPAA Enforcement Actions Security of Electronic Health Information: The HITECH Act Conclusion References Chapter 13: Medical Records and Confidentiality: Evolving Liability Issues Inherent in the Electronic Health Record, HIPAA, and Cybersecurity The Legal Basis of Privacy Protections A Distinction Between Privacy and Confidentiality Privacy and Confidentiality Within the Healthcare Context The Medical Record The Health Insurance Portability NAND Accountability Act of 1996 (HIPAA) Overview of HIPAA The HIPAA Privacy Rule The HIPAA Security Rule The HIPAA Enforcement Rule Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH) HITECH Breach Reporting Requirement Meaningful Use Certification Criteria for EHR Technology Business Associates and the Privacy and Security Provisions of HITECH HIPAA Violation Fines Can Also Be Issued by State Attorneys General References Chapter 14: The Legal and Regulatory Components of Tele-ICU Care Introduction Reimbursement Medicare Medicaid Private Insurance Tele-ICU Regulation Licensing Governing Body Oversight Privacy Protection Medical-Legal Risk Conclusions References Chapter 15: Digital Technologies in Healthcare: Opportunities and Risk for Health Systems and Providers References Chapter 16: The Laws of Professional Negligence: What Is Malpractice – And How Does Litigation Work? Introduction The Requisite Elements of a Cause of Action for Medical Malpractice Duty Breach Causation Res Ipsa Loquitur The Loss-of-Chance Doctrine Damages Defense of Medical Malpractice References Chapter 17: Legal Reasoning: Why the Law and Its Application Are Confusing to Medical Providers Scientific Facts Versus Legal Facts Scientific Proof Versus Legal Proof Legal Terms of Art The Burdens of Proof, Production, and Persuasion The Adversarial System of Justice Precedent: Case Law Successfully Coping with a Medical Malpractice Lawsuit Conclusions References Chapter 18: Ethical Conflicts and Legal Liability in Professional Nursing The Professionalization of Nursing Ethical Conflicts in Professional Nursing Ethics Committees and Litigation Medical Futility Staff Burnout and Moral Distress Staff Turnover Legal Liability in Professional Nursing Statutory Law Common Law Tort Law: Unintentional Torts Tort Law: Intentional Torts Electronic Medical Records (or EMRs) Electronic Medical Records and Their Legal Implications Summary References Chapter 19: Criminal Statutes Affecting Medical Providers Introduction to Criminal Law The Elements of a Crime Basics of Criminal Procedure Accomplice Liability Burden of Proof and Presentation of Evidence Guilty Pleas and Plea Bargaining Federal Criminal Statutes with Risks to Medical Providers Criminal Prosecution for Medical Malpractice Harassment and Criminal Harassment Assault/Battery Criminal Federal Fraud and Abuse Laws Criminal False Claims Statute Criminal Anti-Kickback Statute (AKS) Criminal State Fraud and Abuse Laws Federal Sentencing Guidelines Conclusions References Chapter 20: Ethical and Legal Issues in Contemporary Pharmacy Practice: Scope of Practice, Drug Use Stewardship, Medical Error Management, and Teamwork Federal Regulation of Pharmacy Practice State Regulation of Pharmacy Practice Provider Self-Prescription Antibiotic Stewardship Compounding Case Law in Pharmacy Practice Conclusions and Summary References Chapter 21: Legal Issues in Mental Health Relevant to Acute Care Practice Ethical Issues in the Care of Patients with Mental Illness Involuntary Confinement Suicidal Ideation Tarasov and the Duty to Warn Federal Laws Impacting Mental Health Care Medical Issues in the Care of the Psychiatric Patient Disability of Patients with Mental Illness SARS-CoV-2 and COVID-19: Mental Health Implications Summary and Conclusions References Chapter 22: Clinical Labs: CLIA and Other Evolving Challenges A History and Overview of the Clinical Laboratory Improvement Amendments (CLIA) Relevance of CLIA to Clinical Laboratory Medicine CLIA, HIPAA, and HITECH Potential Legal Liability Under CLIA and CLIA/HIPAA Legal and Ethical Issues in the Disclosure of Individual Research Results Ethical and CLIA Issues Involved in Genetic Testing Tort Law and Legal Liability in Clinical Laboratory Medicine References Chapter 23: Social Work, Care Managers, and Physician Advisors: Liability Related to Discharge Planning and Continuity of Care Ethical Issues in Social Work Legal Issues in Social Work Ethical and Legal Issues in Case and Care Management Ethical and Legal Issues Facing Physician Advisors Conclusions References Chapter 24: Employment and Human Resources Law: An Overview The Definitions of Employee and Independent Contractor The Employer-Employee Relationship Exempt and Non-exempt Employee Status The Employment Contract Agency and Vicarious Liability Employee at Will Brief Summary of Key Statutes and Laws Relating to Human Resources Title VII of the Civil Rights Act of 1964 The Fair Labor Standard Act (FLSA) of 1938 The Family and Medical Leave Act (FMLA) of 1993 The Americans with Disabilities Act of 1990 The Age Discrimination in Employment Act (ADEA) The Occupational Safety and Health Act (OSHA) of 1970 The Patient Protection and Affordable Care Act (PPACA) The Employee Retirement Income Security Act (ERISA) of 1974 The Equal Pay Act (EPA) The Pregnancy Discrimination Act (PDA) The Norris-Laguardia Act of 1932 The National Labor Relations Act (NLRA) of 1935 Genetic Information Nondiscrimination Act (GINA) of 2000 Summary and Conclusions References Chapter 25: Anatomy of Healthcare Contracts: Pitfalls and Avoidance of Liability Introduction The Language of Contracts The Elements of a Contract Defenses to Contract Formation Preliminary Negotiations A General Overview of Contract Clauses General Contract Clauses Employee or Independent Contractor The Contract Term and Termination Clauses Noncompete Agreements Indemnification Clauses Non-solicitation or Noninterference Covenants Entire Agreement Clauses and the Parol Evidence Rule Alternative Dispute Resolution Provisions Potentially Missing Clauses Contract Assignability Anti-kickback Statute and “Stark” Law Compliance Breach of Contract Interpretation of Contracts by the Courts Potential Valid Defenses Against a Breach of Contract Claim Damages Summary References Chapter 26: Corporate and Partnership Structures Used in Healthcare Entity Formation Considerations Regarding Choice of the Business Structure Business Structures ”Doing Business As” (DBA) The Sole Proprietorship Partnerships Professional Corporation Limited Liability Company C-Corporation S-Corporation Important Issues in Corporate Law “Pass-Through” Taxation The Corporate Veil Legal and Ethical Duties of Directors or Board Members Conclusions References Chapter 27: Statutory Controls and Regulation of Pharmaceuticals and Medical Devices The Administrative Procedures Act and the Regulatory Authority of the FDA A Brief History of the FDA and the FDCA Classification of Pharmaceuticals Overview of FDA Regulation of Medical Devices The FDA Safety and Effectiveness Standards Overview of the FDA Approval Process The Approval Process for Biologics Labeling, Marketing, and Misbranding The “Practice of Medicine” Exception: “Off-Label” Uses of Drugs and Medical Devices Biologicals and the Immunization of Vaccines from Liability Litigation Conclusions References Chapter 28: Ethical Principles and Laws Governing Clinical Research Introduction Ethics and Clinical Research Historical Overview of Ethical Perspectives in Clinical Research Societal Benefits Human Subject Protection in Research Benefits of Research in General Research Benefits for the Community Research Ethics and Regulations Codes Bioethical Perspectives in Research Outline of Ethical Principles in Clinical Research The Principal of Scientific Value and Validity The Principle of Subject Selection Risk/Benefit Assessment in Research Independent Review of the Risks of Research The Principle of Informed Consent Participant Respect in Research Ethical Principles Governing Randomized Controlled Trials Conclusion References Chapter 29: State of Emergency: The Laws Governing Natural Disasters and Other Mass Casualty Incidents Disasters and Mass Casualty Events The Development of an Integrated Response System Practical Considerations Healthcare Facility Surge Accommodation Healthcare Facility Security Hospitals as Targets The Model State Emergency Health Powers Act (MSEHPA) and the Ethics of Public Health Responses to MCIs Ethical and Legal Issues in Mass Casualty Events The Emergency Medical Treatment and Labor Act (EMTALA) Specifically, EMTALA Mandates The Health Insurance Portability and Accountability Act (HIPAA) Triage Quarantine Standards of Care for MCI Casualties Provider Post-Traumatic Stress Disorder and Burnout Conclusions References Chapter 30: New and Evolving Frontiers in Resuscitation: Ethical and Legal Concerns Introduction Definition of Research Consent for Resuscitation Research Experiences with Community Consultation and Public Disclosure Oversight of Community Consultation and Public Disclosure Challenges with High-Risk Interventions for Resuscitation and Critical Care Challenges During Disasters and Pandemics References Chapter 31: Defining Standards of Care and the Role of Expert Testimony in Jurisprudence Introduction Tort Law, Professional Negligence, and Medical Malpractice Elements of Medical Malpractice Evolution of the Standard of Care Defining Standard of Care Establishing Standard of Care Role of the Expert Witness Practical Aspects of Expert Witness Testimony Implications of Providing Improper or Unethical Expert Witness Testimony Conclusion References Chapter 32: The Second Victim in Medical Malpractice Litigation: The Stress of Litigation Introduction The Second Victim of Medical Errors Medical Errors and Adverse Events Symptoms of the Second Victim Prevalence and At-Risk Populations Risk Factors and Triggers for Second Victim Phenomena Medical Malpractice Defendant as Second Victim Healing the Second Victim Destructive Coping Strategies Constructive Coping Strategies Organizational Support After Medical Error Resources for Support Coping with the Stress of Litigation Conclusion References Chapter 33: Liability for Advanced Care Practitioners Background Physician Assistants PA Scope of Practice PA Supervision PA Prescriptive Authority PA Practice Environment Nurse Practitioners Nurse Practitioner Scope of Practice Nurse Practitioner Practice Environment Full Practice Reduced Practice Restrictive Practice Nurse Practitioner Scope of Practice Trends Certified Registered Nurse Anesthetists CRNA Practice Environment Malpractice and Liability Legal Theories Negligent Hiring Negligent Supervision Vicarious Liability Mitigating the Risk of Liability Negligent Hiring Negligent Supervision Vicarious Liability Malpractice Trends for Advanced Care Providers Physician Assistants Nurse Practitioners Certified Registered Nurse Anesthetists Summary References A Glossary of Terms Index __The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers__ is a comprehensive resource intended to provide a state-of-the-art overview of complex ethical, regulatory, and legal issues of importance to clinical healthcare professionals in the area of acute care medicine; including, for example, physicians, advanced practice providers, nurses, pharmacists, social workers, and care managers. In addition, this book also covers key legal and regulatory issues relevant to non-clinicians, such as hospital and practice administrators; department heads, educators, and risk managers. This text reviews traditional and emerging areas of ethical and legal controversies in healthcare such as resuscitation; mass-casualty event response and triage; patient autonomy and shared decision-making; medical research and teaching; ethical and legal issues in the care of the mental health patient; and, medical record documentation and confidentiality. Furthermore, this volume includes chapters dedicated to critically important topics, such as team leadership, the team model of clinical care, drug and device regulation, professional negligence, clinical education, the law of corporations, tele-medicine and e-health, medical errors and the culture of safety, regulatory compliance, the regulation of clinical laboratories, the law of insurance, and a practical overview of claims management and billing. Authored by experts in the field, __The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers__ is a valuable resource for all clinical and non-clinical healthcare professionals.