Health Law and Compliance Update, 2021 Edition

The 2021 Health Law and Compliance Update continues a publishing tradition that features national experts who address key developments in health care delivery, payment, and compliance. The authors include practical advice and analytical tools for use in organizational compliance programs, in addition to timely and thorough analysis of many substantive topics.

The 2021 Edition includes detailed coverage and expert insights on the following topics:

• 2021 Health Law Frontiers
• Physician Compliance in the Brave New World of Increased Enforcement
• Compliance Effectiveness in a New Era of Enforcement: Recent Developments and Practical Considerations
• Compliance-Related Federal Tax Issues
• The Patient Safety Act: Lifting the Fog of the Patient Safety Work Product Privilege to Improve Health Care Safety and Quality
• The Affordable Care Act Is Held Unconstitutional by a Federal District Court in Texas
• Payment Issues Update
• Antitrust Compliance Programs in the Era of Health Care Innovation: New DOJ Guidelines and Heightened Enforcement by Federal and State Agencies
• Managed Care Contracts: Carrier Compliance and Health Care Facility Compliance (Physician Office and Hospital)
• Key Partnership: Compliance and the Revenue Cycle

Note: Online subscriptions are for three-month periods.

Previous Edition: Health Law and Compliance Update, 2020 Edition ISBN 9781543810943¿

Chapter 1

2021 HEALTH LAW FRONTIERS: Harold J. Bressler, Prathyusha Matam, Alayna Frauhiger

• Introduction
• Legislative Attempts to Increase Competition Among Drug Developers
• Precision Medicine: Challenges for Patients and Providers

Chapter 2

PHYSICIAN COMPLIANCE IN THE BRAVE NEW WORLD OF INCREASED ENFORCEMENT: Anna M. Grizzle, Lauren Gaffney, Brianna Powell

• Introduction to Physician Compliance
• Overview of Health Care Laws and Enforcement Tools
• Emerging Enforcement Trends Against Physicians
• Minimizing Risk Through a Robust Compliance Plan
• Conclusion

Chapter 3

COMPLIANCE EFFECTIVENESS IN A NEW ERA OF ENFORCEMENT: RECENT DEVELOPMENTS AND PRACTICAL CONSIDERATIONS: Lauren S. Gennett, Isabella E. Wood

• Introduction
• Current Health Care Enforcement Trends
• Evolution of Health Care Compliance Program Expectations
• Key Themes Regarding Compliance Program Effectiveness
• Practical Considerations
• Conclusion
• Appendix A: Various Permutations on the Seven Elements of an Effective Compliance Program

Chapter 4

COMPLIANCE-RELATED FEDERAL TAX ISSUES: LaVerne Woods, David Lawson

• Introduction to Federal Tax Compliance Issues for Hospital Organizations under Code Section 501(c)(3)
• Requirements for Section 501(c)(3) Status Generally
• Special Requirements for Hospital Organizations
• Excess Benefit Transactions
• Excise Tax on Certain Compensation
• Unrelated Business Income Tax
• Joint Ventures with Non-Exempt Entities
• Hospital Participation in Accountable Care Organizations

Chapter 5

THE PATIENT SAFETY ACT: LIFTING THE FOG OF THE PATIENT SAFETY WORK PRODUCT PRIVILEGE TO IMPROVE HEALTH CARE SAFETY AND QUALITY: Wesley R. Butler, Esq., Holly R. Iaccarino, Esq.

• Introduction to Patient Safety
• Diagnosing the Patient Safety Problem: A Need to Re-Define the Culture of Patient Safety
• Congress Responds to the Patient Safety Crisis: Building a New Construct for Health Care Providers
• The Meaning of the “Patient Safety Work Product”
• The Privilege and Confidentiality Protections for PSWP
• Courts and the Patient Safety Act
• Conclusion
• Appendix 5-A Sample Policy—Patient Safety Evaluation System

Chapter 6

THE AFFORDABLE CARE ACT IS HELD UNCONSTITUTIONAL BY A FEDERAL DISTRICT COURT IN TEXAS: Jonathan P. Siner

• Background of Texas v. United States
• Overview of the Applicable Provisions of the Affordable Care Act
• U.S. Supreme Court: National Federation of Independent Businesses v. Sebelius
• Tax Cuts and Jobs Act of 2017 Reduces Individual Mandate “Tax” to Zero
• U.S. District Court: Texas v. United States Holds ACA Unconstitutional
• U.S. Fifth Circuit Court of Appeals: State of Texas, et al. v. USA, et al. on Appeal
• Where Do We Go from Here?

Chapter 7

PAYMENT ISSUES UPDATE: Gregory A. Brodek

• Overview of Federal and State Efforts to Address Balance Billing and Surprise Bills
• Recovery of Provider Overpayments Through Cross-Plan Offsetting

Chapter 8

ANTITRUST COMPLIANCE PROGRAMS IN THE ERA OF HEALTHCARE INNOVATION: NEW DOJ GUIDELINES AND HEIGHTENED ENFORCEMENT BY FEDERAL AND STATE AGENCIES: William E. Berlin, Michael R. Greer, Abigail L. Kaericher, John F. Bowen

• Introduction to Antitrust Compliance Programs
• Innovation and New Entry in Health Care
• Heightened Civil and Criminal Antitrust Enforcement in Health Care
• Elements of an Effective Compliance Program
• Practical Takeaways and Compliance Best Practices

Chapter 9

MANAGED CARE CONTRACTS: CARRIER COMPLIANCE AND HEALTH CARE FACILITY COMPLIANCE (PHYSICIAN OFFICE AND HOSPITAL): Rob Borchert

• Introduction to the History of Managed Care Contracts
• History of Insurance Companies “Road” to Managed Care Contracts
• How Does Compliance Apply to Managed Care Contracts for Both Physicians and Health Care Facilities?
• Contractual Obligations
• Are Defined “Standards” Part of the Compliance Obligation Between All Parties?
• What Are the Obligations of Third-Party Insurance Companies Regarding Compliance to Each Individual Contract?
• Obligations of a Physician Practice (Group or Individual) Regarding Compliance to Each Individual Insurance Company Managed Care Contract
• Obligations of a Health Care Facility (All Types) Regarding Compliance to Each Individual Insurance Company Managed Care Contract
• Understanding Overall Compliance Risk and the Different “Side-Effects”
• Conclusion

Chapter 10

KEY PARTNERSHIP: COMPLIANCE AND THE REVENUE CYCLE: Judy I. Veazie, CRCE, CCT

• Introduction to Compliance and the Revenue Cycle
• Operationalizing Regulatory Updates
• Medicare Secondary Payer Audit Guide
• HIPAA Covered Entities: Provider Obligations to Require Payer Compliance
• Revenue Cycle Mock FBI/OIG Interview and Deposition Checklist

Table of Cases

Index