Introduction

Health care compliance is critical for organizations to maintain integrity, avoid regulatory violations, and ensure quality care. The regulatory landscape in healthcare is complex, with organizations needing to comply with numerous laws and regulations like HIPAA, the Affordable Care Act, anti-kickback statutes, and more. This 5-day Health Care Compliance Training Course will provide participants with a comprehensive understanding of healthcare regulations, compliance frameworks, and how to effectively implement compliance programs within healthcare organizations.

Course Objectives

By the end of the course, participants will:
✔ Understand the legal and regulatory frameworks governing healthcare compliance, including HIPAA, Anti-Kickback Statute, and False Claims Act.
✔ Be able to design and implement an effective compliance program for healthcare organizations.
✔ Understand risk management techniques and how to apply them in healthcare settings.
✔ Learn strategies for ensuring data protection and patient privacy within healthcare institutions.
✔ Gain insights into compliance audits, enforcement mechanisms, and how to manage internal investigations.
✔ Address ethics and conflict of interest issues in healthcare compliance.
✔ Be prepared to navigate the evolving landscape of healthcare policy and regulatory changes.

Who Should Attend?

• Compliance officers and managers in healthcare organizations
• Healthcare attorneys and legal advisors focusing on healthcare regulations
• Hospital administrators and healthcare facility managers
• Privacy officers and information security professionals
• Regulatory professionals working with healthcare entities
• Healthcare providers (physicians, nurses, and allied health professionals) seeking to understand their compliance responsibilities
• Pharmaceutical industry professionals and medical device companies looking to comply with health regulations

Day 1: Introduction to Healthcare Compliance

Session 1: Understanding Healthcare Compliance

• The importance of compliance in the healthcare industry
• Overview of key healthcare laws and regulations
• Risk-based approach to compliance in healthcare
• Common compliance failures and consequences in healthcare organizations
• Case study: The role of compliance in preventing health fraud

Session 2: The Legal Landscape of Healthcare Compliance

• Health Insurance Portability and Accountability Act (HIPAA): Privacy, security, and breach notification requirements
• The Affordable Care Act (ACA) and its compliance impact
• Key provisions of the False Claims Act and Stark Law
• The Anti-Kickback Statute and implications for healthcare professionals and organizations
• Case study: A healthcare provider’s violation of HIPAA and its legal consequences

Session 3: Understanding Compliance Frameworks and Structure

• The components of an effective compliance program: Policies, procedures, and monitoring
• Establishing a compliance committee and the role of compliance officers
• Risk assessment and identifying key areas of non-compliance in healthcare organizations
• Developing a culture of compliance and organizational leadership involvement
• Case study: Developing compliance programs in large hospital systems

Day 2: Compliance Program Design and Risk Management

Session 4: Designing and Implementing a Healthcare Compliance Program

• Key steps to developing a compliance program for healthcare organizations
• Creating policies and procedures to comply with federal and state regulations
• Implementing education and training for employees on compliance requirements
• Developing a monitoring and auditing process to ensure compliance
• Case study: A hospital’s approach to building a comprehensive compliance framework

Session 5: Risk Management and Mitigation in Healthcare Compliance

• Identifying and assessing compliance risks in healthcare organizations
• Techniques for managing compliance risks and preventing violations
• Establishing internal controls to reduce compliance risks
• Responding to compliance breaches and implementing corrective actions
• Case study: Risk management and internal investigations in a healthcare setting

Session 6: Privacy and Data Protection in Healthcare

• Protecting patient data and ensuring compliance with HIPAA Privacy and Security Rules
• The importance of data encryption, audit logs, and access controls
• Addressing data breaches: notification procedures and regulatory requirements
• Compliance challenges with electronic health records (EHR) and telemedicine
• Case study: Data breach management in a healthcare network

Day 3: Audits, Enforcement, and Investigations

Session 7: Healthcare Compliance Audits

• The role of audits in healthcare compliance and their legal significance
• How to conduct internal audits to detect and address compliance gaps
• Understanding external audits and their regulatory impact
• Preparing for an audit and responding to findings
• Case study: A healthcare organization’s audit process in a compliance program

Session 8: Enforcement of Healthcare Regulations

• The role of regulatory agencies: Centers for Medicare and Medicaid Services (CMS), Office of Inspector General (OIG), and others
• Investigations into fraud, abuse, and violations of healthcare regulations
• The penalties and consequences of non-compliance: Civil and criminal enforcement
• Handling civil monetary penalties and managing settlement negotiations
• Case study: False Claims Act enforcement in a pharmaceutical case

Session 9: Conducting Internal Investigations and Responding to Violations

• Steps to initiate an internal investigation into suspected violations
• Handling whistleblower complaints and anonymous reporting systems
• Legal protections for whistleblowers under the False Claims Act
• Responding to violations: Corrective action plans and voluntary disclosures
• Case study: Internal investigations and corrective actions in a healthcare setting

Day 4: Ethics, Conflict of Interest, and Compliance Challenges

Session 10: Ethical Considerations in Healthcare Compliance

• Understanding ethical issues and conflict of interest in healthcare compliance
• How to handle gifts, kickbacks, and financial incentives in healthcare settings
• Ethical challenges in research compliance, especially in clinical trials and patient consent
• Balancing compliance obligations with patient care priorities
• Case study: Conflict of interest and ethical concerns in a pharmaceutical company

Session 11: Managing Conflicts of Interest in Healthcare Compliance

• Identifying and addressing conflicts of interest at both individual and organizational levels
• Policies for managing physician relationships, vendor agreements, and referral arrangements
• Best practices for ensuring transparency and ethical decision-making
• Developing training programs to raise awareness of conflicts of interest
• Case study: Hospital executive’s conflict of interest and its impact on patient care

Session 12: Compliance Challenges in Emerging Healthcare Trends

• Managing compliance in telemedicine, home healthcare, and mobile health apps
• Ensuring compliance with global health regulations for cross-border care
• The rise of artificial intelligence (AI) and its impact on healthcare compliance
• Addressing privacy concerns related to wearable devices and health data analytics
• Case study: Telehealth compliance challenges during the COVID-19 pandemic

Day 5: Current Trends and the Future of Healthcare Compliance

Session 13: Emerging Issues in Healthcare Compliance

• The impact of healthcare technology, such as AI and blockchain, on compliance
• Cybersecurity risks and compliance challenges in healthcare organizations
• Managing compliance with the rise of digital health records, genetic testing, and personalized medicine
• Addressing the future of healthcare fraud and compliance risks
• Case study: Navigating compliance challenges in Genomic data use

Session 14: Preparing for Regulatory Changes in Healthcare

• Keeping up with changing healthcare regulations and their impact on compliance programs
• The future of HIPAA, ACA reforms, and other major healthcare legislation
• Managing healthcare compliance in light of evolving global health crises
• Preparing for the future of healthcare data protection and policy changes
• Case study: Impact of ACA reforms on healthcare compliance

Session 15: Final Review, Q&A, and Certification

• Recap of key concepts learned throughout the course
• Final Q&A session to address any remaining questions and clarifications
• Certification of completion awarded to all participants
• Networking and opportunities for future collaboration

Final Wrap-Up & Certification

• Recap of the key lessons learned throughout the course
• Completion certificates awarded to all participants
• Networking and future collaboration opportunities