Health Law and Compliance Update, 2013 Edition

The 2013 Health Law and Compliance Update brings you the latest information on emerging issues in health law and health care compliance. Each chapter is authored by experts from some of the most prestigious health care organizations and law and consulting firms.

The 2013 Edition includes in-depth, expert-authored analysis of the following topics:

• Compliance-Related Tax Issues
• Medicare Certified Accountable Care Organizations
• The Evolution of Stroke Affiliate Programs in Response to the Shifting Health Care Paradigm
• Medicare Benefits and Coverage
• Compliance Program Monitoring and Auditing Methods and Techniques
• Navigating the Rules for Post-Approval, Noninterventional Studies
• Anatomy of a Business Associate Agreement: An Examination of Regulatory Requirements, Risks, and Practical Suggestions Related to Agreements
• Delivering Effective Health Care Security
• The Responsible Corporate Officer Doctrine and Other Theories Under Which Corporate Officials Can Be Held Liable by Virtue of Their Corporate Position

• 1. YEAR IN REVIEW (John Steiner, Gayland O. Hethcoat II, Rachel Howland, Marilyn Le, William M. Turner, Robert Holland, and Daniel Staren)
  • Physician Payments Sunshine Act
  • Updates on the Red Flags Rule Compliance Obligations for Health Care Providers
  • Employee Retirement Income Security Act (ERISA) Update
  • HEAT and the Fraud Prevention System
  • Constitutional Challenges to the Patient Protection and Affordable Care Act, 2011-2012
  • Personalized Medicine
• 2. COMPLIANCE-RELATED TAX ISSUES (Travis Jackson)
  • Charitable Status for Health Care Organizations
  • Organized and Operated Exclusively for Exempt Purposes
  • Prohibition Against Private Inurement
  • Prohibition Against Private Inurement Excess Benefit Transactions
  • Private Benefit
  • Good Corporate Governance
  • Joint Ventures
• 3. MEDICARE CERTIFIED ACCOUNTABLE CARE ORGANIZATIONS (Mike Segal, Heather Siegel Miller, Stephen H. Siegel, and Fred Segal)
  • The Medicare Shared Savings Program in Depth
  • Federal Antitrust Rules and Their Effect on Accountable Care Organizations
  • Health Information Technology
  • Accountable Care Organization Tax Issues
  • State Law Issues
• 4. THE EVOLUTION OF STROKE AFFILIATE PROGRAMS IN RESPONSE TO THE SHIFTING HEALTH CARE PARADIGM (Farzan Bharucha, Rob Edwards, Michael R. Dobbs, MD, Mark D. Birdwhistell, and Thomas Dixon)
  • Current State of Stroke Networks
  • Future Considerations for Stroke Network Development
  • Legal and Regulatory Implications for Network Development
• 5. MEDICARE BENEFITS AND COVERAGE (Thomas Barker)
  • Covered Benefits
  • Medical Necessity
• 6. COMPLIANCE PROGRAM MONITORING AND AUDITING METHODS AND TECHNIQUES (John Steiner, Paul Flanagan, and Greg Radinsky)
  • Key Principles and Related Developments
  • Audits and Reviews
  • Sampling Techniques
  • EMTALA
  • Clinical Trial Billing
  • HIPAA Auditing - An Expanding Frontier
  • Business Associate Audits
  • Breach Notification Audits
  • OCR Audit Program
• 7. NAVIGATING THE RULES FOR POST-APPROVAL, NONINTERVENTIONAL STUDIES (Judith E. Beach, Andy DeMayo, Kristen Henderson, and Jeffrey Sachs)
  • Value of Post-Approval, Noninterventional Studies
  • Overview of Rules Applicable to Post-Approval, Noninterventional Studies
  • Other Rules to Be Considered in Post-Approval, Noninterventional Studies
  • Rules for Clinical Investigations That Generally Do Not Apply to Post- Approval, Noninterventional Studies
• 8. ANATOMY OF A BUSINESS ASSOCIATE AGREEMENT: AN EXAMINATION OF REGULATORY REQUIREMENTS, RISKS, AND PRACTICAL SUGGESTIONS RELATED TO AGREEMENTS (H. Ward Classen, Marie Fogarty, and Beth Mier)
  • Overview of HIPAA and HITECH
  • Business Associate Agreement Terms
• 9. DELIVERING EFFECTIVE HEALTH CARE SECURITY (Donald Kneitel and Michael Montecillo)
  • Health Care Business and Information Technology Security Drivers and Risk Implications
  • Security Governance, Risk, and Compliance
  • People Security - Identity and Access Management
  • Data Security
  • Application Security
  • Infrastructure and Threat Security
  • A Prioritization Roadmap
• 10. THE RESPONSIBLE CORPORATE OFFICER DOCTRINE AND OTHER THEORIES UNDER WHICH CORPORATE OFFICIALS CAN BE LIABLE BY VIRTUE OF THEIR CORPORATE POSITION (Carolyn Fitzhugh McNiven)
  • Criminal Charges Against Individuals Under the Responsible Corporate Officer Doctrine and Other Theories of Indirect Liability
  • Current Enforcement Environment and Recent Cases of Note
  • Consequences of a Responsible Corporate Officer Criminal Conviction
  • Civil Enforcement Actions: Extent to Which Executives Are Vulnerable