Health Law Jacobi Coleman Elberg Spring 2019 PDF

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Health Law Outline Spring 2019 Professors Jacobi, Coleman, and Elberg

Table of Contents Chapter 1: Cost, Quality, Access, and Choice (p.1) .................................................................. 5 1. 2. 3.

Introduction ..........................................................................................................................5 Justice and Equity ..................................................................................................................5 Equitably Spreading Health Risks ............................................................................................5 The Role of Insurance ........................................................................................................................... 5 The Cost and Benefit of Health Care Spending ..................................................................................... 6 4. What Is Illness? ......................................................................................................................6

Chapter 9: Health Care Reform: The Policy Context (p. 481).................................................... 8 1.

Background and Primers on Health Economics, Health Insurance, and Managed Care ..............8 1) Health Economics ......................................................................................................................... 8 The Concept of Insurance ..................................................................................................................... 8 The Concept of Managed Care ............................................................................................................. 9 2. Cost, Quality, Access, and Choice in the U.S. Health Care System ........................................... 10 1) Access ......................................................................................................................................... 10 Cost .....................................................................................................................................................10 Quality ................................................................................................................................................. 11 Choice .................................................................................................................................................. 11 3. Health Reform Tools ............................................................................................................11 Market-Based Approaches.................................................................................................................. 11 Legislation and Regulation .................................................................................................................. 13

Chapter 10: The Regulation of Insurance and Managed Care ................................................ 14 1.

2. 3.

4.

5.

The Patient Protection and Affordable Care Act .................................................................... 14 1) ACA Title I: Overview .................................................................................................................. 14 ACA Title I: Insurance Reforms – How to expand Acccess? ................................................................ 14 Insurane Regulation Under the Afffordable Care Act ............................................................. 17 Legal and Political Challenges Following the ACA .................................................................. 18 1) Individual Mandate Litigation .................................................................................................... 18 Premium Assistance Tax Credits Litigation .........................................................................................19 Cost-Sharing Reduction Payments Litigation ...................................................................................... 19 Efforts to Repeal and Replace the ACA in 2017 .................................................................................. 19 Tax Reform .......................................................................................................................................... 19 Other Federal Laws Regulating Insurance (p. 609) ................................................................. 19 1) The Health Insurance Portability and Accountability Act of 1996 and COBRA Coverage Requirements ......................................................................................................................................19 The Mental Health Parity and Addiction Equity Act ........................................................................... 19 Antidiscrimination Law .......................................................................................................................19 Regulation of Private Health Insurance Under State Law ....................................................... 20

Chapter 11: Public Health Care Financing Programs: Medicare and Medicaid ........................ 20 1. 2.

Introduction ........................................................................................................................20 Medicare ............................................................................................................................. 20 1) Eligibility ..................................................................................................................................... 21

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Health Law Outline Spring 2019 Professors Jacobi, Coleman, and Elberg Benefits ............................................................................................................................................... 21 Payment for Services ..........................................................................................................................22 Administration and Appeals................................................................................................................23 Medicare Funding ...............................................................................................................................24 Whither/Wither Medicare? ................................................................................................................ 24 3. Medicaid .............................................................................................................................24 1) Eligibility(p. 687) ......................................................................................................................... 24 Benefits ............................................................................................................................................... 25 Medicaid Financing & Payment Services ............................................................................................25 Program Administration and Rights Enforcement: Federal/State Relationship................................. 26 Whither/Wither Medicaid ..................................................................................................................27

Chapter 13: The Structure of the Health Care Enterprise ....................................................... 27 1.

Health Care Organizational Structures .................................................................................. 27 1) The Rise OF Health Care Integration .......................................................................................... 27 1) Taxonomy of Health Care Organizational Structures................................................................. 27 The Current Landscape for Health Care Organizations ......................................................................27 Limited Liability and Corporate Form ................................................................................................. 27

Chapter 6: Liability of Health Care Institutions .....................................................................27 1. 2.

3.

4.

5.

6.

7.

Introduction ........................................................................................................................27 1) Two Historic Barriers to HCO Liability ........................................................................................ 27 Vicarious Liability of Hospitals for Negligence of Medical Staff .............................................. 28 1) Actual Agency and the “Control” Test .......................................................................................28 2) Apparent Agency ........................................................................................................................ 28 Direct Liability of Hospitals ................................................................................................... 28 1) Negligence .................................................................................................................................. 28 1) Corporate Negligence.................................................................................................................29 Liability and the Affordable Care Act ....................................................................................30 1) ACA Coordination Reforms ........................................................................................................30 1) The Effect of Coordination Reforms on Institutional Liability ...................................................30 Tort Liability of Managed Care..............................................................................................30 1) Vicarious Liability........................................................................................................................30 1) Corporate Negligence.................................................................................................................30 Physician Incentive Systems ...............................................................................................................31 Liability of ACOs ................................................................................................................... 31 1) ACOs ........................................................................................................................................... 31 1) Liability Risks ..............................................................................................................................31 Reforming the Tort System for Medical Injuries .................................................................... 31 2) Medical Progress and Other Changes in Health Care Environment .......................................... 31 1) Effects of Malpractice Litigation on Provider Behavior .............................................................31 The Liability Insurance Cycles and Malpractice Crises........................................................................31 Approaches to Reforming the Medical Malpractice System ..............................................................31 Alternative Approaches to the Compensation of Patient Injury ........................................................31 The ACA and Tort Reform ................................................................................................................... 32

Chapter 16: Antitrust ........................................................................................................... 32 1.

Introduction ........................................................................................................................32

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Health Law Outline Spring 2019 Professors Jacobi, Coleman, and Elberg 2.

Cartels and Professionalism..................................................................................................33 1) Classic Cartels .............................................................................................................................33 Collective Activities with Justifications ...............................................................................................33 3. Health Care Enterprises ........................................................................................................34 1) Provider-Controlled Networks and Health Plans ....................................................................... 34 Accountable Care Organizations .........................................................................................................35 Payors with Market Power..................................................................................................................35 Mergers and Acquisitions ...................................................................................................................36

Chapter 4: Confidentiality and Disclosure in the Physician Patient Relationship .................... 37 1. 2. 3.

Hippocratic Oath .................................................................................................................. 37 Breaches of Confidentiality ..................................................................................................37 Federal Medical Privacy Standards Under HIPAA ..................................................................38

Chapter 14: Tax-Exempt Health Care Organizations .............................................................. 43 Corporate Governance and Fiduciary Duties......................................................................... 47 1. 2. 3.

Introduction ........................................................................................................................47 Governance and Fiduciary Duties in Nonprofit and For-Profit Organizations .......................... 47 Conversion, Asset Sales, and Mergers of Nonprofit Corporations ..........................................48

Chapter 2: Quality Control Regulation: Licensing Health Care Professionals .......................... 48 1. 2. 3. 4. 5.

Discipline ............................................................................................................................. 48 Federalism and Prescribing Practices .................................................................................... 49 Complementary and Alternative Medicine............................................................................49 Unlicensed Providers ...........................................................................................................50 Scope of Practice Regulation ................................................................................................ 50

Chapter 15: Fraud and Abuse ............................................................................................... 50 1.

False Claims Act ...................................................................................................................50 1) 31 U.S.C. § 3729 (p. 898) ............................................................................................................ 50 Government and Qui Tam Enforcement ............................................................................................51 31 U.S.C. § 3730 – Civil Actions for False Claims ................................................................................51 Scienter Requirement .........................................................................................................................51 Falsity, Medical Necessity, and Statistical Sampling ...........................................................................52 Materiality ........................................................................................................................................... 53 Additional Enforcement Methods ......................................................................................................53 2. The Anti-Kickback Statute ....................................................................................................54 Mens Rea Under the AKS ....................................................................................................................55 Anti-Kickback Statue Safe Harbors......................................................................................................57 3. The Stark Law ...................................................................................................................... 59 Stark Law: Statute and Regulations (p. 966) .......................................................................................60 42 C.F.R. § 411.351 Definitions ...........................................................................................................60 42 C.F.R. § 411.354 Financial Relationship, Compensation, and Ownership or Investment Interest 61 Notes: Stand in the Shoes ...................................................................................................................62 Stark Law Analytic Framework ............................................................................................................ 62 Stark Exceptions (p. 974) ....................................................................................................................62 42 C.F.R. § 411.357 Exceptions to the Referral Prohibition Related to Compensation Arrangements (p. 975) ................................................................................................................................................62

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Health Law Outline Spring 2019 Professors Jacobi, Coleman, and Elberg 2015 Medicare Physician Fee Schedule Final Rule .............................................................................63 United States ex rel Michael K. Drakeford v Tuomey ......................................................................... 63 4. ACOs and Fraud and Abuse Laws (p. 997) ..............................................................................65

NOTE: Sections are highlighted by professor—Jacobi, Coleman, Elberg

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Health Law Outline Spring 2019 Professors Jacobi, Coleman, and Elberg

Chapter 1: Cost, Quality, Access, and Choice (p.1) 1. Introduction • • • • •

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Cost, quality, access, and choice = chief concerns of health care system Four concerns operating in a dynamic and complex relationship. Dual normative goals of health law = Justice and Protection of Health Law applied is reinterpreted bc health and health care are fundamental needs 3 corners of Health Finance: 1. Health providers 2. Payers 3. Patients Money and obligations flow between the three corners of Health finance Informal caregivers do not fit neatly into these corners 1. Q: Should informal caregivers be financed through health insurance ▪ Pro: valuable service ▪ Cons: drawing line between regular family care and “caregiver; expensive Traditional Healthcare: pay into a pool to cover catastrophic medical costs Modern Healthcare: 1. affirmative social tool 2. improving health status 3. address social determinants that make people sick or keep them well

2. Justice and Equity Three Themes: 1. the allocation of health care resources and costs within U.S. HC system 2. Discrimination 3. Health disparities – population level health difference that is linked to a history of social, economic, or environmental disadvantage Health equity = everyone has fair and just opportunity to be as healthy as possible Social determinants of health = conditions of early childhood, education, employment, income, housing, physical environment, access to food, discrimination, social problems

3. Equitably Spreading Health Risks The Role of Insurance Most countries rely on public health insurance financing system to ensure universal access to health care

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Health Law Outline Spring 2019 Professors Jacobi, Coleman, and Elberg Private health insurance exist...