Schedule

This is a cannot miss opportunity to:

• Hear directly from one of the attorneys who argued Loper Bright before the Supreme Court
• Learn about the case and strategy for attacking the Chevron deference
• Discuss the impact of Loper Bright on the health care industry and predictions for future litigation concerning regulatory guidance

This session will cover key Fraud and Abuse developments over the past year. Highlights include:

• Enforcement trends and recent statistics
• False Claims Act case law and settlements
• New Compliance Guidance
• Stark and Anti-kickback developments
• Reimbursement rollercoaster–340B, coding changes, shifts in payment policy

• The basics of procedural (CPT) and diagnosis (ICD-10) coding for Professional Services
• General guidance on use of the CPT & ICD coding manuals
• The basics of ICD-10-CM and ICD-10-PCS for Facility Services
• Hospital Billing Rules and Payment Systems

• This interactive session is intended to be a tutorial on making effective disclosures and achieving timely resolution through the CMS Voluntary Self-Referral Disclosure Protocol (SRDP)
• When to use (and when NOT to use) the SRDP
• Mandates for submitting timely and accurate disclosures to the SRDP and the consequences for failure to meet them
• Best practices for completing disclosure forms, legal analysis, and cooperation with CMS
• Lessons learned from over a decade of the SRDP -- by both the government and compliance professionals and attorneys
• This session is not an advanced session on the interpretation and application of the federal physician self-referral law

• Innovative health care technology companies and a discussion of how they connect and serve other health care entities including payers and providers
• The applicable laws and regulations that impact health care technology companies
• The unique fraud and abuse and compliance challenges that innovative health care technology companies face based upon the nature of their business model
• Risk mitigation strategies that health care technology companies can employ to serve client needs and improve health care outcomes and quality

• Available Stark Law exceptions and Anti-Kickback Safe Harbors for value-based arrangements and value-based enterprises
• Important differences between the exceptions/safe harbors based on level of risk in the value-based arrangement
• Common compliance issues to watch for when using these exceptions/safe harbors
• Examples of arrangements that can qualify for protection under value-based exceptions/safe harbors
• "Real world" use cases and lessons learned after several years of experience with these exceptions/safe harbors

This session will provide an up to date basic overview of the Physician Self-Referral Law (Stark Law) and its implementing regulations, including the overall framework, interpretations, and potential areas of enforcement risk.

• Overview of the Stark Law Framework and its Exceptions
• Key Definitions and Interpretations, Including Compliance with the "Big 3"
• The Value-Based Framework
• The Group Practice Rules
• Auditing and Monitoring Considerations
• Potential Noncompliance and Self-Disclosures

• Information blocking overview and the Manner Exception–making sense of the alphabet soup of the information blocking rules
• Proposed HTI-2 Rule–potential changes to the rule in a time of uncertain agency authority post-Chevron
• Overview of potential penalties and CMS provider disincentives for information blocking violations
• Update on enforcement–OIG enforcement and the potential for private enforcement in the PointClickCare case and beyond
• Advising regulated actors on ambiguous regulatory text–case studies in practical approaches to implementing the Manner Exception from both an EHR vendor and a health system perspective

This "fireside chat" and Q&A session will examine the Department of Justice's application of its new Corporate Enforcement and Voluntary Self-Disclosure Policy (the "Policy") in the health care context. The speakers will examine recent health care fraud resolutions under the Policy, how the Policy interacts with the Criminal Division’s Corporate Whistleblower Awards Pilot Program as well as other federal stakeholders’ self-disclosure policies, and the collateral consequences that self-disclosure can present for health care industry participants. The Q&A portion will also invite candid input from the audience about how the Health Care Fraud Unit can promote trust and transparency in its implementation of the Policy. Learning Objectives:

• The DOJ Criminal Division’s new Policy as applied to the health care industry
• Recent criminal healthcare fraud enforcement decisions under the Policy
• Share feedback with DOJ’s Health Care Fraud Unit and the U.S. Department of Health and Human Services’ Office of Inspector General about how they can better explain and implement their respective self-disclosure policies

• This interactive session is intended to be a tutorial on making effective disclosures and achieving timely resolution through the CMS Voluntary Self-Referral Disclosure Protocol (SRDP)
• When to use (and when NOT to use) the SRDP
• Mandates for submitting timely and accurate disclosures to the SRDP and the consequences for failure to meet them
• Best practices for completing disclosure forms, legal analysis, and cooperation with CMS
• Lessons learned from over a decade of the SRDP -- by both the government and compliance professionals and attorneys
• This session is not an advanced session on the interpretation and application of the federal physician self-referral law

• Purposes of the FCA and its application to health care
• Conduct prohibited by the FCA
• Use of FCA to enforce other statutes and regulations (e.g., AKS, Stark Law, medical necessity requirements)
• Roles of government agencies and whistleblowers in FCA cases
• Life cycle of an FCA case
• Current hot topics in FCA enforcement

• The impact of AI on health care
• The legal and ethical concerns raised by AI
• New and emerging compliance requirements
• The risks and benefits of AI use within the health care industry
• The ethical duties of attorneys in the practical use of AI
• A checklist for establishing AI governance and compliance

• Quality reporting is often distinct from organizational legal and compliance functions
• However, government agencies have articulated an increased focus on quality. Coupled with the industry transition from fee-for-service to value based health care delivery, quality reporting is an emerging and growing area that is important for compliance and legal professionals to gain proficiency in
• Key CMS quality reporting programs, including the mechanics of data reporting and electronic medical record requirements
• The enforcement environment and risks in this growing area, including recent case law and settlements as well as regulatory agency developments including the focus on quality and payment incentives articulated by OIG in its November 2023 updated compliance guidance
• Practical strategies, challenges and opportunities that legal and compliance professionals can consider to mitigate risk in this evolving space, including with respect to the integration of the quality function in compliance structures, risk assessments, internal audits, policies and procedures, risk-based training, and other enhancements

• The current state of private equity investment in health care
• Increased government scrutiny of private equity in health care - What really matters to the government?
• Key enforcement actions and cases involving private equity in health care
• The False Claims Act’s role in policing private equity’s involvement in health care
• State scrutiny of private equity in health care
• Practical considerations in risk assessment and compliance measures for private equity firms investing in health care

• Key F&A and reimbursement principles associated with use of APPs
• Guidance from OIG and DOJ, including advisory opinions and important cases and settlements
• Utilize hypotheticals to tease out the “do’s and don’ts” in structuring arrangements to expand the use of APPs

• Best practices for engaging with healthcare enforcement regulators (DOJ, HHS OIG, DEA, etc.) in response to government inquiries or investigations. 
• Strategies for proactively reporting regulatory concerns to government agencies.
• Insights from a current HHS OIG senior counsel and former Assistant U.S. Attorneys and with extensive experience navigating complex healthcare regulatory environments.
• Understanding the priorities and perspectives of different healthcare enforcement agencies to inform engagement strategies

Current instability in the provider market raises a host of new challenges for health care entities, which this session with explore, including:

• Maintaining a viable health care operation in the face of volatile provider staffing conditions–how much extra cost can a health care entity absorb
• How to determine fair market value when confronting critical shortages and market conditions are far less predictable
• Challenges ensuring compliance with other key regulatory requirements when providers shortages are driving crucial decisions
• How to create a compliance checklist that is workable in difficult market conditions, including practical examples
• How to support FMV through good documentation of inputs, including recruitment and negotiation history

Medicare providers can continue to provide telehealth at home until December 31, 2024. This session will focus on potential FCA or AKS risks in this uncertain landscape where DOJ remains committed to combatting telemedicine fraud post-pandemic:

• The impact of HHS-OIG’s special fraud alert regarding telehealth arrangements
• How telemedicine has proven to increase access to care and paving the way for AI to increase that access, especially in area of behavioral health
• Telehealth cases and settlements for post-pandemic enforcement trends of the DOJ’s nationwide coordinated law enforcement action to combat telemedicine, laboratory and durable equipment fraud
• CMS’s proposed changes to Medicare telehealth policies
• Establish practices and procedures to comply with the alert towards mitigating potential FCA and AKS risks

• Website disclosures in health care
• New restrictions on reproductive health care information
• HIPAA enforcement priorities
• New state privacy laws
• Turning good information security into good compliance documentation
• Part 2 vs. the Privacy Rule
• What are Part 2 Programs
• The New Part 2
• Part 2 Disclosures

• Recent developments in AKS and EKRA enforcement in lab cases
• Genetic testing schemes, and COVID testing Fraud
• Recent cases involving telehealth and lab marketing, along with a look at AI in the lab industry
• Cases involving independent contractors, and the risk of in-office personnel
• Urinary Drug Screening and Addiction Recovery Fraud

Managed care enforcement is a top priority for the government. Recent record-breaking settlements and judgments illustrate the government’s commitment to combatting alleged fraud in managed care.  DOJ’s recent criminal indictment against a certified coder underscores its scrutiny of this area – and we anticipate many more civil, criminal, and administrative actions in this area. This panel of experts, including an official from HHS-OIG, will focus on recent enforcement trends and oversight activities in the managed care space.

• Key trends in managed care enforcement and risk areas for plans, MSOs, and providers
• Suggestions on how to manage risk from a compliance perspective
• Focus areas and recent takeaways from HHS-OIG

Across all segments of the health care industry, the role of the Chief Compliance Officer has become ever more critical. Over the past decade, the core function of leading the development and implementation of the organization’s compliance program has expanded to include service as the Chief Ethics, the Chief Privacy and in some spaces, the Chief Risk Officer.   Often reporting to the Chief Executive Officer and the Board of Directors, or one of its standing committees, the position now requires a spectrum of leadership skills, pragmatic judgment, courage and the ability to serve effectively as a “source of truth” for internal and external stakeholders.   Today, a successful Chief Compliance Officer must focus not only on the prevention, detection and mitigation of key risks, but on the creation of enterprise value.

This panel discussion will explore these topics in considerable detail, offering observations, insights and a sense of what the future might hold in the era of Artificial Intelligence and unprecedented stakeholder expectations.

• Differentiate between auditing and monitoring and when each should be used
• Outline the roles of compliance, internal audit and legal counsel in auditing and monitoring
• Explain different audit strategies, sampling methodologies, and extrapolations
• Discuss the importance of data credibility and common audit pitfalls to avoid
• Describe best practices in action plan development and follow-up activities

• AI has already invaded healthcare, understanding where
• Get a seat at the table, there is too much risk if you don’t
• AI is the future, learn about it, learn from it, mitigate the risks
• The role of a solid data governance structure
• What your providers don’t know can hurt them, help them understand AI

• Quality reporting is often distinct from organizational legal and compliance functions
• However, government agencies have articulated an increased focus on quality. Coupled with the industry transition from fee-for-service to value based health care delivery, quality reporting is an emerging and growing area that is important for compliance and legal professionals to gain proficiency in
• Key CMS quality reporting programs, including the mechanics of data reporting and electronic medical record requirements
• The enforcement environment and risks in this growing area, including recent case law and settlements as well as regulatory agency developments including the focus on quality and payment incentives articulated by OIG in its November 2023 updated compliance guidance
• Practical strategies, challenges and opportunities that legal and compliance professionals can consider to mitigate risk in this evolving space, including with respect to the integration of the quality function in compliance structures, risk assessments, internal audits, policies and procedures, risk-based training, and other enhancements

• The current state of private equity investment in health care
• Increased government scrutiny of private equity in health care - What really matters to the government?
• Key enforcement actions and cases involving private equity in health care
• The False Claims Act’s role in policing private equity’s involvement in health care
• State scrutiny of private equity in health care
• Practical considerations in risk assessment and compliance measures for private equity firms investing in health care

• The current state of the law for using statistical sampling and extrapolation to support overpayments with government and commercial payors
• The current state of the law for using statistical sampling and extrapolation to support damages calculations in government investigations and FCA litigation
• The current state of the law for using statistical sampling and extrapolation by IROs for companies under a CIA
• The key issues being litigated with the use of statistical sampling and extrapolation in the administrative, civil, and FCA arenas, including the anticipate impact of Loper Bright Enterprises
• How artificial intelligence (AI) is currently being used and the potential future applications in the data analytics, audit process, and estimative process

• Key and developing areas whistleblowers are calling about, including private equity, Medicare Advantage, medical necessity, telehealth and PBMs
• What is the role for kickback cases in light of recent caselaw developments?
• What is the impact of internal whistleblowing systems and compliance on potential qui tam cases?
• How can companies respond to internal whistleblower complaints to avoid a qui tam case?
• What is the impact of DOJ’s new whistleblower program?

Medicare providers can continue to provide telehealth at home until December 31, 2024. This session will focus on potential FCA or AKS risks in this uncertain landscape where DOJ remains committed to combatting telemedicine fraud post-pandemic:

• The impact of HHS-OIG’s special fraud alert regarding telehealth arrangements
• How telemedicine has proven to increase access to care and paving the way for AI to increase that access, especially in area of behavioral health
• Telehealth cases and settlements for post-pandemic enforcement trends of the DOJ’s nationwide coordinated law enforcement action to combat telemedicine, laboratory and durable equipment fraud
• CMS’s proposed changes to Medicare telehealth policies
• Establish practices and procedures to comply with the alert towards mitigating potential FCA and AKS risks

• 2024 Enforcement areas that are hot (Conflicts of Interest etc.)
• Areas of heightened scrutiny by the OIG and DOJ, and potential election impact
• Risk transfer insurance options available
• Practical Tips and coverage pitfalls to avoid (pursuing coverage effectively)

• Innovative health care technology companies and a discussion of how they connect and serve other health care entities including payers and providers
• The applicable laws and regulations that impact health care technology companies
• The unique fraud and abuse and compliance challenges that innovative health care technology companies face based upon the nature of their business model
• Risk mitigation strategies that health care technology companies can employ to serve client needs and improve health care outcomes and quality

• Available Stark Law exceptions and Anti-Kickback Safe Harbors for value-based arrangements and value-based enterprises
• Important differences between the exceptions/safe harbors based on level of risk in the value-based arrangement
• Common compliance issues to watch for when using these exceptions/safe harbors
• Examples of arrangements that can qualify for protection under value-based exceptions/safe harbors
• "Real world" use cases and lessons learned after several years of experience with these exceptions/safe harbors

This "fireside chat" and Q&A session will examine the Department of Justice's application of its new Corporate Enforcement and Voluntary Self-Disclosure Policy (the "Policy") in the health care context. The speakers will examine recent health care fraud resolutions under the Policy, how the Policy interacts with the Criminal Division’s Corporate Whistleblower Awards Pilot Program as well as other federal stakeholders’ self-disclosure policies, and the collateral consequences that self-disclosure can present for health care industry participants. The Q&A portion will also invite candid input from the audience about how the Health Care Fraud Unit can promote trust and transparency in its implementation of the Policy. Learning Objectives:

• The DOJ Criminal Division’s new Policy as applied to the health care industry
• Recent criminal healthcare fraud enforcement decisions under the Policy
• Share feedback with DOJ’s Health Care Fraud Unit and the U.S. Department of Health and Human Services’ Office of Inspector General about how they can better explain and implement their respective self-disclosure policies

• How legal and compliance personnel should think about controls for managing risks associated with research misconduct and data falsification, when dealing with both research misconduct regulations (applicable to work supported by federal agencies such as NIH) and clinical trials subject to FDA oversight
• How health care institutions need to refine their institutional controls for investigating allegations of research misconduct in light of significant changes to federal regulations that are expected to be finalized by the federal Office of Research Integrity in the second half of 2024
• How health care institutions should be managing the significant reputational risks associated with high-profile allegations of research misconduct and data falsification
• The implications of the False Claims Act for research misconduct cases, including in particular when research misconduct allegations relate to work that is cited in applications for federal funding (e.g., NIH grant applications), and how institutions can manage False Claims Act risk in an era of rising numbers of allegations and limited precedent as to False Claims Act settlements and cases that relate to research misconduct

Current instability in the provider market raises a host of new challenges for health care entities, which this session with explore, including:

• Maintaining a viable health care operation in the face of volatile provider staffing conditions–how much extra cost can a health care entity absorb
• How to determine fair market value when confronting critical shortages and market conditions are far less predictable
• Challenges ensuring compliance with other key regulatory requirements when providers shortages are driving crucial decisions
• How to create a compliance checklist that is workable in difficult market conditions, including practical examples
• How to support FMV through good documentation of inputs, including recruitment and negotiation history

Across all segments of the health care industry, the role of the Chief Compliance Officer has become ever more critical. Over the past decade, the core function of leading the development and implementation of the organization’s compliance program has expanded to include service as the Chief Ethics, the Chief Privacy and in some spaces, the Chief Risk Officer.   Often reporting to the Chief Executive Officer and the Board of Directors, or one of its standing committees, the position now requires a spectrum of leadership skills, pragmatic judgment, courage and the ability to serve effectively as a “source of truth” for internal and external stakeholders.   Today, a successful Chief Compliance Officer must focus not only on the prevention, detection and mitigation of key risks, but on the creation of enterprise value.

This panel discussion will explore these topics in considerable detail, offering observations, insights and a sense of what the future might hold in the era of Artificial Intelligence and unprecedented stakeholder expectations.

• Key and developing areas whistleblowers are calling about, including private equity, Medicare Advantage, medical necessity, telehealth and PBMs
• What is the role for kickback cases in light of recent caselaw developments?
• What is the impact of internal whistleblowing systems and compliance on potential qui tam cases?
• How can companies respond to internal whistleblower complaints to avoid a qui tam case?
• What is the impact of DOJ’s new whistleblower program?

• The impact of AI on health care
• The legal and ethical concerns raised by AI
• New and emerging compliance requirements
• The risks and benefits of AI use within the health care industry
• The ethical duties of attorneys in the practical use of AI
• A checklist for establishing AI governance and compliance

Managed care enforcement is a top priority for the government. Recent record-breaking settlements and judgments illustrate the government’s commitment to combatting alleged fraud in managed care.  DOJ’s recent criminal indictment against a certified coder underscores its scrutiny of this area – and we anticipate many more civil, criminal, and administrative actions in this area. This panel of experts, including an official from HHS-OIG, will focus on recent enforcement trends and oversight activities in the managed care space.

• Key trends in managed care enforcement and risk areas for plans, MSOs, and providers
• Suggestions on how to manage risk from a compliance perspective
• Focus areas and recent takeaways from HHS-OIG

• Information blocking overview and the Manner Exception–making sense of the alphabet soup of the information blocking rules
• Proposed HTI-2 Rule–potential changes to the rule in a time of uncertain agency authority post-Chevron
• Overview of potential penalties and CMS provider disincentives for information blocking violations
• Update on enforcement–OIG enforcement and the potential for private enforcement in the PointClickCare case and beyond
• Advising regulated actors on ambiguous regulatory text–case studies in practical approaches to implementing the Manner Exception from both an EHR vendor and a health system perspective

• 2024 Enforcement areas that are hot (Conflicts of Interest etc.)
• Areas of heightened scrutiny by the OIG and DOJ, and potential election impact
• Risk transfer insurance options available
• Practical Tips and coverage pitfalls to avoid (pursuing coverage effectively)