Physician Law

Name: Physician Law | Evolving Trends & Hot Topics 2022
Brand: American Bar Association
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Evolving Trends & Hot Topics 2022

Wes M. Cleveland(Herausgeber*in)

American Bar Association (Verlag)

Erschienen am 18. August 2022

414 Seiten

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Inhalt

Intro
Title Page
Copyright Page
Contents
Foreword
Physicians Legal Issues Conference 2022 Planning Committee
Chapter 1: Entrepreneurial Medicine: Fraud and Abuse Risk Areas for Physician Business Relationships
I. Introduction
II. Federal Fraud and Abuse Laws
A. The Federal Anti-Kickback Statute
1. Exceptions and Safe Harbors to the Anti-Kickback Statute
a. Exceptions to the Anti-Kickback Statute
b. Safe Harbors to the Anti-Kickback Statute
2. OIG Special Fraud Alerts, Bulletins, and Other Guidance Involving Physicians
a. OIG Special Fraud Alert: Speaker Programs
b. OIG General Policy Statement Regarding Gifts of Nominal Value to Medicare and Medicaid Beneficiaries
3. 2015 OIG Fraud Alert: Physician Compensation Arrangements May Result in Significant Liability
4. 2014 OIG Special Fraud Alert Regarding Laboratory Payments to Referring Physicians
5. Recent Changes to the Anti-Kickback Statute for Value-Based Arrangements and Other Areas
B. The False Claims Act
1. Whistleblower Actions under the FCA
2. Examples of Potential False Claims for Items and Services
3. Penalties for Violation of the FCA
4. The 60-Day Overpayment Report and Refund Obligation
C. The Stark Law
1. Scope of the Stark Law Physician Self-Referral Prohibition
2. Examples of Physician Relationships Subject to the Stark Law
3. Penalties for Stark Law Violations
4. Exceptions to the Stark Law Physician Self-Referral Prohibition
5. Differences between Stark Law and the Federal Anti-Kickback Statute
6. Stark Law and Hospital Ownership
7. Recent Stark Law Changes and Clarifications
a. New Stark Law Compensation Exceptions:
b. Changes Affecting Physician Group Compensation
8. Stark Law Self-Referral Disclosure Protocol
D. The Civil Monetary Penalties Law
1. Civil Monetary Penalties Law-False or Fraudulent Claims
2. Examples of Recent CMPL Settlements Involving Physicians
E. Exclusion Authorities
1. Mandatory Exclusion
2. Permissive Exclusion
3. Exclusion Liability
4. OIG Guidance on Permissive Exclusion
F. Eliminating Kickbacks in Recovery Act of 2018 (EKRA)
III. Fraud Risk Areas with Physician Business Relationships
A. Physician Employment and Professional Service Agreements
1. Employment Relationship
2. Fraud and Abuse Concerns
3. Compliance Recommendations
a. Exceptions and Safe Harbors to the Anti-Kickback Statute for Employing Physicians and Contracting for Professional Services
b. Stark Law Exceptions Related to Compensation Arrangements
4. Recent Settlements Based on Compensation by Physician Practices to Owner and Employed Physicians
5. Recent Cases and Settlements Based on Compensation by Hospitals and Health Systems to Employed or Contracted Physicians
B. Payments to Physicians for Other Than Professional Services
1. General Description and Compliance Recommendations
2. Recent Enforcement Actions and Settlements
C. Joint Ventures
1. General Description
2. General Compliance Recommendations
3. Recent Enforcement Actions and Settlements Involving Physician Joint Ventures
D. Service Line Co-Management Arrangements
1. General Description
a. Structures of Service Line Co-Management Agreements
b. Services and Compensation
2. Fraud and Abuse Concerns
3. Compliance Issues and Recent Guidance
a. Co-Management Services and Compensation
b. Concerns under the Civil Monetary Penalties Law
4. The Federal Anti-Kickback Statute
5. General Recommendations to Address Fraud and Abuse Concerns
E. Gainsharing Arrangements
F. Medical Directorships
1. General Description
2. Fraud and Abuse Concerns
3. Compliance Guidance
a. Anti-Kickback Safe Harbors
b. Stark Law Exceptions
c. General recommendations
4. Recent Cases and Settlements Involving Medical Director Agreements
G. Free or Discounted Items and Services
1. General Description
2. Fraud and Abuse Concerns
3. Recent Guidance
4. Recent Settlements and Voluntary Self-Disclosures
H. Call Coverage Agreements
1. General Relationship
2. Fraud and Abuse Concerns
a. Anti-Kickback Concerns
b. Stark Law Concerns
3. Guidance Involving Call Coverage Agreements
I. FCA Cases Based on Physicians Providing Medically Unnecessary Services
J. Recent Settlements Related to Physician Billing
IV. Concierge Medicine
A. General Description
B. Concierge Medicine vs. Direct Primary Care
C. Compliance Concerns
1. General Description
D. Compliance Issues and Recent Government Guidance
1. Private Payor Compliance Issues
2. Recent Civil Monetary Penalty Settlements
V. Physician-Owned Medical Device Distributorships
A. Fraud and Abuse Concerns
B. OIG Special Fraud Alert Physician-Owned Entities
C. Cases and Settlements Involving PODs
VI. Fraud and Abuse Risks with Electronic Health Records Arrangements and Electronic Health Record Billing Arrangements
A. Fraud and Abuse Concerns with Electronic Health Record Arrangements
B. Stark Law and Applicable Exceptions
1. EHR Exception
2. Electronic Prescribing Exception
3. Community-Wide Health Information Exception
4. The Cybersecurity Technology and Related Services Exception
C. Anti-Kickback Statute.
D. Recent Government Settlements, Advisory Opinions and Guidance
1. Recent Settlements Involving EHR Systems
2. OIG Advisory Opinion 12-20 Free Access to an Electronic Interface to Physicians
3. CMS Stark Law Advisory Opinion 2008-01
4. OIG Alert-Information Blocking and the Federal Anti-Kickback Statute
5. Information Blocking Final Rule
E. EHR Billing Concerns
1. General Description
2. Compliance Concerns
3. Compliance Issues and Recent Government Guidance
a. Up-Coding and Cloning
b. OIG Concerns
c. OIG 2017 Audit Report on Payment of Meaningful Use Incentive Payments
d. Medicare Contractor Warnings
Chapter 2: Evolving Trends in Physician-Hospital Contracting: Integration, Relationships, and Collaborations Toward Accountable Care
I. Introduction
II. Regulatory Framework of Physician Arrangements
A. Recruiting Agreements
1. Stark Law
2. Anti-Kickback Statute
B. Employment Agreements
1. Stark Law
2. AKS
C. Professional/Personal Services Agreements-Physician Staffing Models
1. Stark Law
2. AKS
D. Potential Changes to the Regulatory Framework
1. Risk-Sharing and Value-Based Reimbursements
a. Value-Based Contracting Arrangements
b. Changes in Recruitment Strategies
c. Possible Changes in Law to Facilitate New Compensation Models in Hospital-Physician Contracts
III. AMA Physician Employment Principles
A. Potentially Problematic Aspects of Employer-Employee Relationships
1. Conflicts of Interests
2. Advocacy for Patients and the Profession
3. Contracting
4. Hospital Medical Staff Relations
5. Peer Review and Performance Evaluations
6. Payment Agreements
B. Related Codes of Medical Ethics
IV. Contractual Issues with Physician Arrangements
A. Standard Contract Provisions and Process
1. Standard Provisions
2. Contracting Process
3. Physician and Hospital Interests
a. Physician's Perspective
b. Hospital's Perspective
B. Current Contractual Hot Spots
1. Due Diligence and Related Terms When Acquiring the Physician Practice in Conjunction with Employment/ Contracting
2. Non-Competition and Non-Solicitation
3. Terms and Standards of Care
4. Disability Insurance
5. Extended Reporting "Tail" Policy
Appendix 1: AMA Principles for Physician Employment
I. AMA Principles for Physician Employment
1. Addressing Conflicts of Interest
2. Advocacy for Patients and the Profession
3. Contracting
4. Hospital Medical Staff Relations
5. Peer Review and Performance Evaluations
6. Payment Agreements
Appendix 2: Standard Provisions in a Physician-hospital Contract Govern the Following Areas
Appendix 3: Physician Recruitment and Generic Checklist
Appendix 4: OSU Wexner Medical Center Office of Legal Services Guidelines for Interactions with Physicians for Recruitment Purposes
Chapter 3: Medical Professional Liability: Trends in Claims and Legislative Responses
Introduction
Part A-Medical Professional Liability Claims Trends
Introduction to the Data Sharing Project
Data Sharing Project Data: Claims Analysis
Claim Details
Trend Analysis of Claims by Close of Year
Comparative Payment Analysis by Close Year
Comparative Payment Threshold Analysis by Specialty
Comparative Total Expense Payments by Specialty
Claims by Adjudication Status
Summary
Part B-Medical Professional Liability Legislative Trends
State Reforms
Supplemental Reforms
Alternative Reforms
The Future of State Reforms
Federal Reforms
Traditional Reforms
Additional Reforms
Targeted Reforms
The Future of Federal Reforms
Summary
Conclusion
Chapter 4: Telemedicine
I. Introduction: What Is Telehealth? Is It Different from Telemedicine?
A. COVID-19
B. Telehealth vs. Telemedicine
C. Telehealth Modalities
D. Online Questionnaires
II. State-specific Regulatory Issues
A. Licensure
B. Licensure Exceptions
C. Interstate Licensure Compacts
D. Establishing a Physician-Patient Relationship
E. Patient Consent
F. Patient and Provider Verification/Validation
G. Medical Records and Patient Privacy
H. Remote Prescribing
III. Reimbursement
A. Medicare Reimbursement
B. Telehealth Beyond "Medicare Telehealth Services"
C. Medicaid Reimbursement
D. Private Payers
E. Cash Pay
IV. Fraud And Abuse Issues Unique to Telehealth
A. Federal Kickback and Beneficiary Inducement Restrictions
B. Federal Self-Referral Prohibition
C. Value-Based AKS Safe Harbors and Stark Exceptions
D. False Claims Act and Civil Monetary Penalties
E. State Fraud and Abuse Laws
F. Corporate Practice of Medicine and Fee-Splitting
V. Miscellaneous
A. Proxy Credentialing
B. Malpractice Insurance
Chapter 5: HIPAA Compliance: Privacy, Security and Breach Obligations
Evolution of HIPAA
Application of HIPAA to Physicians
The HIPAA Privacy Rule
Individual Rights Established by the Privacy Rule
Use and Disclosure of PHI-Individual Authorizations
Uses and Disclosures-Without Authorization
Disclosures to Business Associates
Minimum Necessary Requirement and Limited Data Sets
Other Administrative Requirements
The HIPAA Security Rule
Breach Notification Rule
HIPAA Enforcement
Other Legal Developments
Private Enforcement Actions
State Laws and HIPAA Preemption
Chapter 6: Accountable Care Organizations-Overview
I. What Are ACOs?
A. History and Background
B. The Affordable Care Act
II. The Center for Medicare and Medicaid Innovation and Current ACO Models
A. The Center for Medicare and Medicaid Innovation
B. ACO Models
1. Medicare Shared Savings Program (MSSP) ACO Models (BASIC and ENHANCED Tracks)
2. Pioneer ACO Model
3. ACO Investment Model (AIM)
4. The Next Generation ACO Model
5. The Comprehensive ESRD Care (CEC) Model
III. Legal Issues
A. Antitrust
B. Anti-Kickback Statute/Stark/Gainsharing Civil Monetary Penalty Waivers
1. Brief description of the Anti-Kickback/Stark/Gainsharing Civil Monetary Penalty Laws
2. The CMS, FTC, and OIG Workshop, and Subsequent Waivers of Applicability of the Anti-Kickback, Stark, and Gainsharing CMP Laws to MSSP ACOs
C. The Anti-Kickback Safe Harbors and Stark Exceptions
D. Tax-Exempt Status
E. State Insurance Laws
IV. Practical issues
A. Who Are Members?
B. What Does the Structure Look Like?
C. Who Controls/Leads?
D. Size
V. Viability
A. Viability of ACOs under MACRA
VI. Conclusion
Chapter 7: Doctors' Defense in Medical Staff Hearings and Appeals: An Overview for Attorneys and their Physician Clients
I. Introduction
II. Anatomy of a Medical Staff Hearing and Repercussions Resulting from a Negative Outcome
1. The Need for Legal Counsel
a. Right to Representation
b. How Lawyers Are Selected
c. Cost
d. Hospital and Medical Staff Lawyers
e. Hearing Officers
2. Governing Law
a. Federal Health Care Quality Improvement Act
b. State Immunities and Confidentiality Law
c. State Procedural Law
d. Reporting Requirements
3. Medical Staff Bylaws
a. Accreditation Requirements
b. State Law Requirements
c. Enforceability as Contract
4. Hearing Procedural Roadmap
a. Notice of Proposed Action
b. Notice of Hearing
c. Discovery
d. Evidence
e. Witnesses
f. Hearing Body Composition and Voir Dire
g. Pre-Hearing Conference
h. Hearing Record
i. Counsel/Representative in the Hearing
j. Burden of Proof
k. Written Memoranda
l. Decision
5. Summary Suspension
6. Appeals
7. Alternative Dispute Resolution
8. Effect of Employment or other Hospital Contracts
III. Advice for Those Participating in a Medical Peer Review
1. Preventive Medicine for Avoiding Peer Review
2. Prescriptions for the Target of Peer Review
a. Physicians Should be Proactive in Their Defense
b. Legal Counsel Should Be Proactive not just during the Hearing Stage but Early in the Process:
IV. Conclusion
Chapter 8: Physician Well-Being: Healing the Healer-Assisting Physicians with Substance Use Disorders and Other Health Issues
I. Introduction
II. Unique Features of Physicians in General
III. Physicians and Personality Styles
IV. Physician Addiction in the Workplace: Identification, Intervention and Assessment
A. Identification of Addiction in the Workplace
B. Intervention
C. Assessment
D. The Role of the Well-Being Committee
V. Comprehensive Evaluation
A. Vignette
1. Simply More Depressed than Usual
2. Intervening
B. Potential Reporting Requirements
C. The Comprehensive Assessment Points to Remember
VI. Physician Health Programs
A. Caduceus Groups
B. The American Medical Association Physician Wellness Program
C. State Licensing Boards
D. Employee Assistance Programs
E. Physician Impairment Independent of Addiction
VII. Legal Concerns
A. Fair Procedure
B. The Americans with Disabilities Act and the Rehabilitation Act
C. The Age Discrimination in Employment Act
D. Federal and State Reporting Laws
E. Federal and State Privacy Laws
VIII. An Integrative Approach to Treatment
A. Use of Mindfulness and Meditation
IX. Levels of Care
A. Day or Evening Intensive Outpatient Program (IOP)
B. Partial Hospital Program
C. Inpatient Rehabilitation or Residential Treatment
X. Specialized Treatment for Professionals
XI. Monitoring and Support Systems
XII. Stress Management
XIII. Summary
Chapter 9: The Alphabet Soup of Medicare and Medicaid Contractors
I. Introduction
II. Medicare Contractors
III. Claims Processing Contractors
A. Fiscal Intermediaries and Carriers
B. Specialty Claims Processing Contractors
C. Medicare Contracting Reform-MACs, DME MACs, PDACs, and HH+H MACs
D. Medicare Administrative Contractors
E. MAC Medical Review
F. MAC Improper Payment Outreach and Education Program
IV. The Middle Ground: Contractors in Between Claims Processing and Program Integrity
A. Comprehensive Error Rate Testing
B. National Supplier Clearinghouse (NSC)
C. Quality Improvement Organizations (QIOs)
D. Recovery Audit Contractors (RACs)
E. Medicare RACs
F. Medicare Parts C & D RACs
V. Medicare Program Integrity Contractors
A. Zone Program Integrity Contractors (ZPICs)
B. Medicare Drug Integrity Contractor (MEDIC)
C. Benefit Coordination and Recovery Center (BCRC)
VI. Medicaid Contractors
A. Medicaid RACs
B. Medicaid Integrity Program (MIP)
C. Payment Error Rate Measurement Program (PERM)
VII. The Future of CMS Contracting
A. Supplemental Medical Review Contractor (SMRC)
B. Unified Program Integrity Contractors (UPIC)
VIII. Conclusion
Chapter 10: Physician Employment Contracts from the Physician Perspective
I. Introduction
II. Letter of Intent
III. General Principles of Contract
IV. Physician Employment Contract Terms Concerning the Employment Term
A. Representations
B. Scope of Duty
1. Clinical Responsibilities, Hours, Call Schedule, Facilities, and Equipment
2. Administrative Responsibilities
3. Marketing Responsibilities
4. Outside Work
5. Intellectual Property
C. Compensation
1. Base Salary
2. Productivity/Quality Payment
3. Discretionary Bonuses
4. Signing Bonus
5. The Pandemic's Effect
D. Benefits
1. General Employment Benefits
2. Benefits Specific to Physicians
3. Malpractice Coverage
E. Ownership/Partnership
V. Regulatory Issue Spotting
VI. Physician Employment Contract Terms Concerning Termination of Employment
A. Reasons for Termination of Physician Employment Contract
1. No-Cause Termination
2. For-Cause Termination
3. Disability of Physician
B. Contract Provisions Triggered by Termination of Contract
1. General Obligations
2. Repayment of Bonuses
3. Tail Insurance
4. Productivity Compensation Due
5. Restrictive Covenants
a. Validity
b. Non-Compete Clause
c. Non-Solicitation Clauses
6. Medical Records
VII. Alternative Dispute Resolution
VIII. Negotiation of Physician Employment Contracts
A. Gather Feedback
B. Create Value
C. Address Weaknesses
D. Creative Solutions
E. Salary Negotiation
F. Summary
IX. Considerations Beyond the Face of the Contract
X. Conclusion
About the Authors
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