Laws of Medicine: Core Legal Aspects for the Healthcare Professional

Preface
Contents
Contributors
Part I: Introduction to US Legal System
U.S. Government
1 Introduction
2 Discussion
2.1 The U.S. Constitution
2.2 The Three Branches of Government and What They Do
2.3 Federalism
2.4 Supremacy Clause
2.5 Sources of Law
Statutes
Regulations
Case Law
2.6 Statutes vs. Other Sources of Law
2.7 The United States is a Common Law Country
2.8 The Judiciary and the Case Law System
3 Application
4 Summary
References
The Courts
1 Introduction
2 Discussion
2.1 Introduction to the Courts
2.2 Dual Federal and State Court Systems
2.3 The Federal Courts
Organization
Hierarchical Organization of the Federal Courts
Geographical Distribution of the Federal Courts
Qualifications, Selection, and Tenure of Federal Judges
Federal Courts as Courts of General or Specialized Jurisdiction
Federal Courts as Courts of General Jurisdiction
Specialized Federal Judicial Bodies
Limited Competence of the Federal Courts
Subject Matter Jurisdiction
Justiciability
Proceeding Through the Federal Courts
Proceeding Through the U.S. District Courts
Proceeding Through the U.S. Courts of Appeals
Proceeding Through the U.S. Supreme Court
2.4 The State Courts
2.5 Standards of Proof
2.6 Choosing a Court
2.7 Stare Decisis and the Importance of Judicial Precedent
Introduction
Benefits of Stare Decisis
Application of Stare Decisis Principles
Scope of the Earlier Decision
Whether an Earlier Judicial Decision Is Binding or Persuasive
When Will the Supreme Court Overrule Itself?
Super Precedent
Stare Decisis and State Law and State Courts
2.8 Due Process
3 Application
4 Summary
References
Anatomy of a Lawsuit
1 Introduction
2 Discussion
2.1 Governing Rules
2.2 Commencing a Lawsuit
Cause of Action and Damages
Filing a Complaint
Answering the Complaint
Additional Pleadings
2.3 Pre-Trial Activities
Discovery
Motions Practice
Orders
2.4 Trial
Judge Versus Jury Trial
Procedural Overview
Opening Statements
Presentation of Case by Plaintiff
Presentation of Defense by Defendant
Possible Rebuttal by Plaintiff
Closing Statements
Verdict
Additional Motions Practice
2.5 Costs of Trial
2.6 Appeals
2.7 Settlement, Mediation, and Arbitration
Generally
Settlement
Mediation
Arbitration
3 Application (Cases and Examples)
4 Summary
References
Contract Law
1 Introduction
2 Discussion
2.1 Which Promises Does the Law Enforce?
Bargains
Reliance
2.2 Contract Interpretation and Formation
Written and Oral Contracts
Contract Formation
2.3 Excuses to Contract Performance
2.4 Legal Remedies in Contract Law
3 Application
4 Summary
References
Part II: Public Health Law
Public Health Law
1 Introduction
2 Public Health Law
2.1 Foundational Public Health Laws
2.2 Sources of Public Health Authority
The U.S. Constitution
Statutes
Regulations
Executive Orders
Case Law
Tribal Sovereignty
2.3 Limitations on Public Health Authority
Due Process
Preemption
3 Law as a Social Determinant of Health
4 Public Health and Legislation “By the People”
5 A Look at Global Public Health Law
5.1 Interventional Public Health Law: Two Selected Examples
Chronic Disease Prevention and the Law
Application: Hypothetical Case Study
Legal Framework
Law and Injury Prevention and Control
Application: Hypothetical Case Study
Legal Framework
6 Summary
References
Part III: Access to Care
Emergency Medical Treatment and Labor Act (EMTALA)
1 Introduction
2 Discussion
2.1 “Medicare-Participating Hospitals”
2.2 “Emergency Department”
2.3 “Any Individual”
2.4 “Comes To”
2.5 “Medical Screening Examination”
2.6 “Emergency medical condition”
2.7 “Stabilize”
2.8 Capability
2.9 Transfers
2.10 On-call Physicians
2.11 Enforcement Mechanisms
2.12 Public Emergencies
3 Application
4 Summary
References
Healthcare Reform
1 Introduction
2 Discussion
2.1 A Brief History of U.S. Health Reform
2.2 Passing the ACA
2.3 Understanding the ACA
2.4 Access to Coverage: The Individual Mandate, Guaranteed Issue, and Beyond
2.5 Exchanges
2.6 Medicaid Expansion
2.7 Additional Provisions and Financing
2.8 Implementing the Affordable Care Act
2.9 Challenges to the ACA
2.10 Constitutionality: NFIB v. Sebelius and California v. Texas
2.11 Exchanges: King v. Burwell
2.12 Coverage Requirements: Hobby Lobby
3 Application
4 Summary
References
Part IV: Tort Law
Malpractice
1 Introduction
2 Discussion
2.1 Medical Malpractice
2.2 Medical Battery
2.3 Informed Consent
2.4 Vicarious Liability
2.5 Federal Tort Claims Act
2.6 Tort Reform
3 Application
4 Summary
References
Liability in Reproduction and Birth
1 Introduction
2 Discussion
2.1 Informed Consent
2.2 Wrongful Death
2.3 Assisted Reproductive Technologies
Procreation Imposed: Wrongful Birth and Wrongful Life Claims
Procreation Confounded
Procreation Denied
2.4 Abortion
2.5 Labor and Delivery
2.6 Postpartum Care
2.7 Application (Cases and Examples)
Application 1: Wrongful Birth and Wrongful Life
Application 2: Informed Consent in Childbirth
Application 3: Post-Natal Care and Maternal Death
3 Summary
References
Product Liability
1 Introduction
2 Discussion
3 Applications
3.1 Federal Preemption
3.2 Jurisdictions
4 Summary
References
Part V: Administrative Law
Administrative Law—And Its Application in Health Law
1 Introduction
2 Discussion
2.1 Importance of State Regulation of Medicine
2.2 The Administrative Process—the Dichotomy Between Adjudication and Rulemaking
Rulemaking
Presidential Involvement in Rulemaking
Interpretive Rules, Policy Statements, and Guidelines
Adjudication Under the APA
Formal Adjudication
Due Process and Informal Adjudication
Choice of Procedures
2.3 Judicial Review of Administrative Action
Availability of Judicial Review
Standing to Sue
Timing of Judicial Review
The Forum for Judicial Review
Scope of Review
Review of the Agency’s Fact Finding
Review of Legal Interpretations
Non-Judicial Means of Accountability
2.4 Application of Administrative Law to Health Law
The Department of Health and Human Services
Food and Drug Administration
Centers for Medicare & Medicaid Services
OMHA
Centers for Disease Control and Prevention
National Institutes of Health
Social Security Administration
Department of Labor
Black Lung Benefits Program
OSHA
Department of Veterans Affairs
3 Application
4 Summary and Conclusion
References
Licensing Boards
1 Introduction
2 Discussion
3 Application
4 Summary
References
Part VI: Federal Regulations
Health Privacy, Security, and Information Management
1 Introduction
2 Discussion
2.1 State Professional Practice Acts
2.2 State Facility Licensing Laws
2.3 Federal Medicare Conditions of Participation
2.4 The Federal HIPAA Privacy Rule
2.5 The Federal HIPAA Security Rule
2.6 The Federal HIPAA Breach Notification Rule
2.7 State Consumer Data Protection Laws
2.8 Federal Consumer Data Protection Bills
3 Summary
References
Corporate Practice of Medicine
1 Introduction
2 Discussion
2.1 Background
2.2 Applicability of the CPOM Doctrine
2.3 Healthcare Consolidation and the CPOM Doctrine
3 Application
4 Summary
References
Transparency and the Federal Physician Payments Sunshine Act
1 Introduction
2 Discussion
2.1 Voluntary Industry Efforts
2.2 State Laws
2.3 Federal Transparency Efforts
2.4 Federal Physician Payments Sunshine Act (PPSA)
Applicable Manufacturers
Covered Recipients
Reportable Payments and Transfers of Value
Food and Beverage
Excluded Payments and Transfers of Value
Reported Information
Reportable Ownership or Investment Interests
Research Payments
Covered Recipient Review and Dispute of Reported Data
Penalties for Noncompliance
Relationship to State Sunshine Laws
Use of PPSA Information
3 Application
4 Summary
References
Labor and Employment Issues for Clinicians
1 Introduction
2 Restrictive Covenants
2.1 Discussion
2.2 Application
3 Discrimination
3.1 Discussion
3.2 Application
4 Labor Law
4.1 Discussion
4.2 Application
5 Independent Contractors
5.1 Discussion
5.2 Application
6 Summary
References
Part VII: Healthcare Fraud and Abuse
The False Claims Act
1 Introduction
2 Discussion
2.1 The Statute
2.2 The Elements of the False Claims Act
The Claim
Falsity
Knowledge
Materiality
Damages
Whistleblower Provisions
2.3 Qui Tam Procedure
3 Government Intervention Decision
4 Dismissal of a Qui Tam Action
4.1 Retaliation Provisions
4.2 Relator’s Share and Attorney’s Fees
5 Application
5.1 Medical Necessity
5.2 Upcoding
6 Summary
References
The Anti-Kickback Statute
1 Introduction
2 Discussion
2.1 Elements of AKS Violation
Knowingly and Willfully to Induce Referrals
2.2 Collective Knowledge
Renumeration
Safe Harbor Exceptions to the Anti-Kickback Statute
3 Application
3.1 Speaker Programs
3.2 Electronic Health Records
3.3 Telemedicine, Durable Medical Equipment, Genetic Testing, and Compound Pharmacies
4 Summary
References
The Stark Law
1 Introduction
2 Discussion
2.1 Elements of Stark Violation
Designated Health Services
Financial Relationship
Referrals
2.2 Stark Safe Harbors
Rental of Office Space [13]
Bona Fide Employment Relationships [13]
Personal Services Arrangements [13]
In-Office Ancillary Services [11]
2.3 Self-Disclosure Protocols
3 Application
4 Summary
References
Office of Inspector General Administrative Authorities
1 Introduction
2 Discussion
2.1 Bases for Imposition of Civil Monetary Penalties and Exclusion
2.2 OIG Administrative Procedures
2.3 Exclusion in Context of DOJ Civil and Criminal Cases
3 Summary
References
Criminal Healthcare Fraud
1 Introduction
2 Discussion
3 Application
4 Summary
References
Part VIII: Antitrust Law
Antitrust Law
1 Introduction to Antitrust Law
2 Price Fixing and Monopolization
2.1 Section 1 of the Sherman Act
2.2 Application
2.3 Section 2 of the Sherman Act
2.4 Application
3 Exclusive Contracts
3.1 Application
4 Mergers and Acquisitions
5 Joint Ventures
5.1 Application
6 Summary
References
Part IX: FDA Law
Drug and Medical Device Law
1 Introduction
2 History of Drug and Device Regulation
3 Drugs
4 Expedited Programs
4.1 Fast Track
4.2 Accelerated Approval
4.3 Priority Review
4.4 Breakthrough Therapy
5 Orphan Drugs
6 Controlled Substances
7 Prescription vs Non-prescription
8 Over-The-Counter (OTC) Drugs
9 Generic Drugs
10 Devices
11 Off-Label Use
12 Off-Label Promotion
13 Preapproval Access
13.1 Emergency Use Authorization (EUA)
13.2 Expanded Access Program (EAP)
13.3 Right-to-Try Act (RTT)
14 Application
14.1 U.S. v. Caronia 703 F.3d 149 (2d Cir. 2012)
15 Summary
References
Tobacco Regulations
1 Introduction
2 Discussion
3 Ingredients
4 Approval Process
5 Labeling/Marketing
6 Tobacco in Minors
7 Application
7.1 Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509 (6th Cir. 2012)
8 Summary
References
Artificial Intelligence: A Legal Landscape
1 Introduction
2 Regulation of AI
2.1 FDA Regulation of AI
Proposed Regulatory Pathway
FDA’s 2021 Action Plan Update
Exclusion from FDA Regulation
Alternative to FDA Regulation
2.2 FTC Regulation of AI
3 Artificial Intelligence and Tort Law
4 Artificial Intelligence and Intellectual Property
5 Application (Examples)
5.1 Example 1: FDA Regulation
5.2 Example 2: Dermatology—Convolutional Neural Network for Skin Lesion Image Classification
6 Summary
References
Part X: Intellectual Property Law
Patent Law
1 Introduction
2 Discussion
3 Application
4 Summary
References
Copyright and Trademark Law
1 Introduction
2 Discussion
2.1 Copyright
2.2 Original
3 Works of Authorship
3.1 Fixed in a Tangible Medium of Expression (Fixation)
3.2 Case Example
3.3 Copyright Does Not Protect Nonoriginal Material, Ideas, or Functional Aspects
3.4 Case Example
4 Copyright Ownership
5 Fair Use
6 Trademark
6.1 Case Example
6.2 Acquiring Trademark Rights
6.3 Applications
7 Summary
References
Part XI: Mental Health Law
Psychiatric Hospitalization and Civil Commitment
1 Introduction
2 Discussion
2.1 Brief History and Legal Basis for Civil Commitment in the United States
2.2 Emergency Detention
2.3 Civil Commitment Laws
Definitions of Mental Illness
Definitions of Dangerousness
Procedural Protections
2.4 Civil Commitment Outcomes
2.5 Voluntary Psychiatric Hospitalization
3 Application
3.1 Clinical Vignette A: Determining Dangerousness
3.2 Clinical Vignette B: Least Restrictive Treatment Setting
3.3 Clinical Vignette C: Informed Consent to Hospitalization
4 Summary
References
Confidentiality and Privilege
1 Introduction
2 Discussion
2.1 Privilege and its Exceptions under Maryland State Law
2.2 Duty to Warn, Maryland State Law
2.3 Excerpt of Maryland’s Duty to Warn Law
3 Application
4 Summary
References
Part XII: Law and Bioethics
Informed Consent
1 Introduction
2 Discussion
2.1 The Scope of Disclosure
2.2 Specifics of the Disclosure: To Disclose or Not to Disclose
2.3 Delegability of Disclosure
2.4 The Referring Physician & Informed Consent
2.5 Causation Requirement
2.6 Consent Forms
2.7 Obtaining Informed Consent from Patients Incapable of Giving Informed Consent to Treatment
3 Application
4 Summary
References
Right to Decisional Privacy
1 Introduction
2 Discussion
3 Application
4 Summary
References
Human Subjects Research
1 Introduction
2 Discussion
2.1 Historical Background
2.2 Federal Regulations and Related Laws Today
2.3 Key Features of the Federal Regulations
2.4 What Counts as “Research”?
Application
Clinical Vignette # 1
Application
Clinical Vignette # 2
2.5 Who Is a “Human Subject?”
Application
Clinical Vignette # 3
2.6 What Research Activity Is “Exempt” from the Regulations?
2.7 IRB Review and Specialized Consent
2.8 The Critical Role of the IRB
2.9 Informed Consent Requirements
2.10 Conflicts of Interest
Application
3 Summary
References
Next-Generation Genomic Sequencing and Clinician Liability
1 Introduction
2 Discussion
2.1 Informed Consent and Genetic Testing
2.2 Genetic Privacy
2.3 Genetic Information and Nondiscrimination
3 Summary
References
Decisions Near the End of Life
1 Introduction
2 Determination of Death
3 Refusal of Life-Sustaining Treatment: The Legal Consensus
4 Competent Patients
5 Competence and Decisional Capacity
6 When Families Decide for Incompetent Patients
7 When Patients Have Advance Directives
7.1 Formal Requirements
7.2 Decision Making with Advance Directives
8 POLST: Physician (Provider) Orders for Life-Sustaining Treatment
9 When the Patient’s Wishes are Unknown
10 When the Patient is Incarcerated
11 Medical Futility
12 Professional Conscience
13 Ethics Committees and Ethics Consultants
14 Legal Liability and “Wrongful Prolongation of Life”
15 Medical Aid in Dying
16 Application
16.1 Clinical Vignette 1
16.2 Clinical Vignette 2
17 Summary
References
Part XIII: Right to Healthcare
Is There a Right to Health in U.S.?
1 Introduction
2 Health as a Human Right
2.1 The Right to Health Under International Law
2.2 Is There a Right to Health Under U.S. Law?
3 Judicial Approach
4 Legislative Approach
4.1 Government-Funded Programs to Guarantee Health Coverage
4.2 Other Guarantees of Basic Health Coverage
5 What’s Next?
References
Healthcare Should Be a Right
1 Introduction
2 Discussion
3 Application
3.1 Clinical Vignette
4 Summary
References
Index