Schedule

This session will provide an up-to-date basic overview of the Anti-Kickback, Physician Self-Referral Law (Stark Law) and Civil Monetary Penalty Laws, including their frameworks, practical implications and potential areas of enforcement risk. Topics covered will include:

• Overview of the Kickback, Stark, CMPs, their Frameworks and 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

Live stream for virtual attendees. 

• Best practices when negotiating a CIA
• Preparing for the "New Normal"–establishing an effective support system by engaging governance, counsel, and executive leadership
• Feedback from the OIG Monitor and the CIA mandated Compliance Expert to educate leadership and clinicians on the importance of an effective compliance program
• Using the CIA as an opportunity to enhance business practices by improving operational efficiency and shared accountability for compliance and ethics
• Keys to aligning long-term business strategies with compliance goals

Live stream for virtual attendees. 

This session will deliver practical advice from an experienced panel on the “dos and don’ts” of responding to government enforcement agency inquiries. Avoiding missteps in the response to a government inquiry is critical to minimize the impact on the organization's operations. This session will address the following scenarios:

• Responding to different government methods of investigation, including CIDs, grand jury subpoenas or the execution of search warrants
• Conducting parallel internal investigations or self-audits
• Ensuring appropriate use of attorney-client privilege during investigations
• The importance of collaborating and cooperating with government agents

• The changes to CMS and OIG guidance on use of sampling and extrapolation for self-auditing
• Key challenges to raise in defending an extrapolated overpayment in contractual and administrative appeals
• The changes in federal law as a result of current litigation on government payors
• How generative artificial intelligence (gAI) is anticipated to impact the use of sampling and extrapolation and potential challenges to the evidence that gAI programs produce in reimbursement disputes

Live stream for virtual attendees. 

• HIPAA Administrative Transactions
• Adoption of Standards
• Complaint Adjudication Process
• Compliance Review Process
• Complaint Submission Portal/Testing Tool

Live stream for virtual attendees. 

• The key provisions of the False Claims Act
• The primary application to the health care and life sciences industries
• The key current enforcement theories against the healthcare and life sciences industries, including the Anti-Kickback Statute
• Liability and damages theories and primary defenses
• Risk areas and effective compliance strategies
• Examples of recent enforcements actions and trends

Live stream for virtual attendees. 

As scrutiny intensifies around financial arrangements between health care providers and the pharmaceutical industry, compliance leaders and health care attorneys must develop a robust, defensible approach to commercial reasonableness (CR) and fair market value (FMV). Regulators and enforcement agencies, including CMS, HHS-OIG, and the DOJ, continue to refine CR and FMV expectations, leading to evolving legal interpretations and increased enforcement activity. This session will discuss:

• Regulatory history, agency guidance, and recent high-profile settlements to compare and contrast CR from FMV as distinct concepts and to extract key insights and practical strategies
• In-depth legal, operational, and risk-based framework for ensuring that financial relationships—ranging from physician compensation to pharma-provider contracts—are commercially reasonable and within FMV
• Proactive compliance program design, detailing how to structure oversight mechanisms, conduct risk assessments, and document CR and FMV defensibly to mitigate legal exposure and protect against enforcement actions

• What is AI?
• Why do we care?
• How is AI affecting the practice of law?
  • Discovery, document review, contract analysis and due diligence
  • Legal document generation
• How will AI affect our clients? How are healthcare stakeholders using AI?
• Ethical issues
  • Rules and formal ethics opinions

Applying for Legal Ethics credit for this session. 

Live stream for virtual attendees. 

• 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

Live stream for virtual attendees. 

This session will discuss the plethora of risk associated with research compliance from the Common Rule, FDA regulations, Medicare billing compliance, HIPAA and other regulations. It will address how these risks may occur without knowledge of the compliance department or the organization’s leadership. Many health care organizations may not be aware of the range of research activity that could be occurring in their organization. For those that do research but are not large academic medical centers there may not be an appreciation of all the risk. It is very difficult to find individuals with the subject matter expertise across the regulatory spectrum that research encompasses. Even within large academic medical centers and university health systems, coordinated and centralized research review and approval processes are essential to understanding and managing research risk. We will discuss:

• The risk areas of research and why it is difficult to have a comprehensive compliance program that addresses all risks
• The unique challenges for smaller health systems and physician practices
• How central IRBs for multi-center trials add to the complexity
• Ways to help mitigate the risks

Live stream for virtual attendees. 

• Fundamentals of Risk Adjustment Coding: Overview of the risk adjustment process, including the assignment of ICD-10-CM codes, the role of Hierarchical Condition Categories (HCCs), and the calculation of risk scores to align payments with patient health status and expected care costs
• Compliance and Documentation Best Practices: Emphasizing the importance of accurate medical record documentation to support coding, avoid over- or under-coding, and mitigate risks of audits and financial penalties
• Key Enforcement Priorities, Trends and Developments: Insights into federal enforcement actions targeting Risk Adjustment coding practices, including analysis of DOJ litigation against major Medicare Advantage Organizations, the increasing use of Risk Adjustment Data Validation (RADV) audits with extrapolated findings, and heightened scrutiny on in-home health risk assessments
• Corporate Integrity Agreements (CIAs) and Compliance Obligations: Exploration of evolving requirements of risk adjustment-focused CIAs
• Practical Strategies for Risk Adjustment Compliance: Guidance on building robust risk adjustment compliance programs, fostering organizational transparency, and proactively addressing coding discrepancies to avoid regulatory pitfalls

• With DOJ health care enforcement in flux in the new administration, health care attorneys are closely monitoring recent enforcement initiatives by state Attorney General Medicaid Fraud Control Units
• For years, state MFCUs have been extremely active, investigating a wide range of health care providers, including investigations involving long term care, home health, life sciences, private equity, and transportation companies. Those efforts are only likely to increase in the next four years
• Not infrequently, MFCUs partner with DOJ health care fraud prosecutors in joint state-federal investigations. Typically, those state-federal investigations proceed together, but, recently, some MFCUs have brought and litigated cases when DOJ has declined to do so.
• Defending providers in MFCU investigation raise unique, state-specific challenges for defense counsel
• In this panel, two Medicaid Fraud prosecutors from different states will join two former DOJ prosecutors with active MFCU practices to provide their perspective on current MFCU enforcement priorities along with best practices for defending clients in these challenging investigations

Live stream for virtual attendees. 

• Session details will be available soon

Live stream for virtual attendees. 

You have attended the Fraud and Compliance Forum and learned about the hot topics and trends in health care law, but what can you do now as in-house counsel to proactively ensure compliance and improve your company’s legal position in the event of future investigations or litigation? This panel will answer that question with regard to issues like:

• Artificial Intelligence
• Coding Audits
• Stark and Anti-kickback Compliance
• Dispute Resolution in Company Contracts

Live stream for virtual attendees. 

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

• Enforcement trends under the Trump Administration
• The Government’s increased focus on Managed Care Fraud
• False Claims Act case law and settlements
• New Compliance Guidance
• Stark and Anti-kickback developments
• Reimbursement rollercoaster– Medicaid cuts, 340B, coding changes, shifts in payment policy

Live stream for virtual attendees. 

In early January 2025, a federal grand jury returned a criminal indictment against Chesapeake Regional Medical Center in Virginia. The hospital was charged with a health care fraud conspiracy resulting from medically unnecessary procedures performed by one of its employed physicians.

The presenters–a health care fraud defense lawyer and health system chief compliance officer–will discuss the CRMC indictment including the allegations, the government's theories of liability, and advice for keeping your client off of the government's target list.

• Recent enforcement trends and False Claims Act litigation against clinical laboratories, remote patient monitoring providers, and durable medical equipment suppliers
• How do recent cases and the administration’s enforcement priorities impact DOJ’s approach to FCA cases, and the opportunities recent case law provide the defense bar
• Potential pitfalls for the unwary and how can practitioners avoid them
• The trends the defense bar, regulatory counsel, and the Government have observed over the past year

Live stream for virtual attendees. 

• Ongoing Compliance Requirements for VBEs–Overview of monitoring requirements governing value-based enterprises (VBEs)/value-based arrangements (VBAs), including those set forth in the Anti-Kickback Statute safe harbors and the Stark Law exceptions. Discussion of how these requirements impact compliance obligations for value-based arrangements
• How Compliance for VBAs Differs from Traditional Physician Arrangements–Comparison of the prospective nature of monitoring compliance for VBAs versus the upfront compliance evaluation done for traditional physician arrangements
• Preparing for Compliance Monitoring Before Developing a VBE–Establish a compliance framework before developing a VBE, including defining key risk areas, setting baseline metrics, and ensuring data-sharing capabilities. Conduct due diligence on regulatory obligations and create clear contractual compliance requirements for all participants
• Immediate Compliance Actions Upon Entering a VBA–Implement real-time monitoring systems, establish reporting structures, and train all stakeholders on compliance protocols. Conduct an initial risk assessment to identify vulnerabilities and ensure alignment with AKS and  Stark requirements
• Best Practices and Tools for Effective Compliance Monitoring–Utilize data analytics, automated auditing tools, and regular self-assessments to track compliance in real time. Establish a compliance committee, structured workflows, and routine reporting mechanisms to ensure consistent oversight and accountability
• Risks of Inadequate Monitoring and Corrective Actions–Failure to monitor compliance can lead to regulatory violations, significant financial penalties, and reputational damage. If issues are identified, conduct an internal review, implement corrective action plans, and engage legal counsel to mitigate risk and maintain program integrity

• Fundamentals of Risk Adjustment Coding: Overview of the risk adjustment process, including the assignment of ICD-10-CM codes, the role of Hierarchical Condition Categories (HCCs), and the calculation of risk scores to align payments with patient health status and expected care costs
• Compliance and Documentation Best Practices: Emphasizing the importance of accurate medical record documentation to support coding, avoid over- or under-coding, and mitigate risks of audits and financial penalties
• Key Enforcement Priorities, Trends and Developments: Insights into federal enforcement actions targeting Risk Adjustment coding practices, including analysis of DOJ litigation against major Medicare Advantage Organizations, the increasing use of Risk Adjustment Data Validation (RADV) audits with extrapolated findings, and heightened scrutiny on in-home health risk assessments
• Corporate Integrity Agreements (CIAs) and Compliance Obligations: Exploration of evolving requirements of risk adjustment-focused CIAs
• Practical Strategies for Risk Adjustment Compliance: Guidance on building robust risk adjustment compliance programs, fostering organizational transparency, and proactively addressing coding discrepancies to avoid regulatory pitfalls

Live stream for virtual attendees. 

• With DOJ health care enforcement in flux in the new administration, health care attorneys are closely monitoring recent enforcement initiatives by state Attorney General Medicaid Fraud Control Units
• For years, state MFCUs have been extremely active, investigating a wide range of health care providers, including investigations involving long term care, home health, life sciences, private equity, and transportation companies. Those efforts are only likely to increase in the next four years
• Not infrequently, MFCUs partner with DOJ health care fraud prosecutors in joint state-federal investigations. Typically, those state-federal investigations proceed together, but, recently, some MFCUs have brought and litigated cases when DOJ has declined to do so.
• Defending providers in MFCU investigation raise unique, state-specific challenges for defense counsel
• In this panel, two Medicaid Fraud prosecutors from different states will join two former DOJ prosecutors with active MFCU practices to provide their perspective on current MFCU enforcement priorities along with best practices for defending clients in these challenging investigations

Live stream for virtual attendees. 

• Using hypotheticals, this interactive presentation will consider some common mistakes encountered in physician self-referral law (PSL) analysis
• This intermediate session will focus on certain elements of the PSL that can cause confusion when analyzing an arrangement or submitting s self-disclosure under the SRDP
• The presenters will walk through the process of applying each element of the PSL to real-world scenarios that can result in problematic analysis when an element is skipped or applied incorrectly

Live stream for virtual attendees. 

Artificial Intelligence is part of our everyday life and it continues to grow and expand in its applications in healthcare at a fast pace. This session will discuss:

• How AI in health care is growing and how it is being regulated, or not regulated
• Risk areas such as coding, diagnosis, and patient care impact, including ambient listening and authorizations
• Enforcement areas, including privacy, patient care, and deceptive marketing
• Considerations for setting up compliance monitoring that is specific to AI to help establish due diligence and avoid allegations of reckless disregard for AI risks

Live stream for virtual attendees. 

Fraud and abuse enforcement remains a top priority for the federal government—but in a new administration, the rules of engagement are shifting. This dynamic panel will explore how evolving policy priorities under the Trump administration are reshaping the fraud and abuse landscape for healthcare and life sciences organizations. From the administration’s growing scrutiny of DEI programs, its expanded use of the False Claims Act as a tool for enforcement, to broader shifts in immigration policy, international collaboration, and academic operations, we’ll explore how these priorities are fueling new and evolving risks. Attendees will gain practical insights into:

• The latest developments and enforcement trends in fraud and abuse enforcement
• The impact of the administration’s DEI-related policies on False Claims Act enforcement
• Specific compliance challenges facing academic medical centers, health care organizations, and life sciences companies
• How to assess and mitigate institutional exposure in today’s uncertain regulatory environment

• Health care settlements and compare and contrast government-initiated cases vs. relator-initiated cases
• Compare the various self-disclosure requirements and benefits of the various regulatory agencies (i.e. OIG and DOJ)
• Understanding the risks of not investigating, remediating, and self-disclosing issues
• Conducting an internal investigation to fully identify the issue, compliance failures, and required remediation
• Factors to consider before an organization self-discloses

Live stream for virtual attendees. 

• Foundational and emerging regulatory frameworks impacting behavioral health, including federal and state laws, recent updates, and enforcement priorities
• New legal developments and evolving standards around privacy, consent, telehealth, and technology (AI) adoption with guidance on risk mitigation and compliance integration
• Essential elements of effective compliance programs and tailored best practices for behavioral health providers
• Real-world case examples to illustrate compliance challenges, solutions, and lessons learned, and provide strategies for future readiness and adaptability

Live stream for virtual attendees. 

The discussion will provide overview and analysis of the fraud and abuse risks related to direct and indirect incentive compensation and other payments between physician practice management (“PPM”) companies and licensed practitioners. We will also provide an overview of different payment structures that, if structured appropriately, can mitigate risk with respect to applicable healthcare fraud and abuse laws, including the Anti-Kickback Statute and the Stark law. These types of payments can be common in privately owned PPM companies, both when affiliating or acquiring new providers, as well as in the context of restructurings. The discussion would include: 

• Common instances where such payments may be desired including:
  • Annual bonuses
  • Equity in the management services organization
  • Retention payments
• Common Payment structures, their relative risk under applicable fraud and abuse laws, and historic enforcement actions related to such payments. This would include, but not be limited to:
  • True-up payments in the context of physician practice acquisitions
  • MSO equity purchase through
    • FMV purchase
    • MSO financing
    • Payment of bonuses, and/or
    • Rollovers; and
      • phantom equity
• Best practices to mitigate risk under the forgoing arrangements. This would include a discussion of statutory and regulatory guidance regarding practices that were determined to be noncompliant, as well as possible alternatives to consider

Live stream for virtual attendees. 

The health care industry thrives on data. This data–most of it about people–is heavily regulated. We have known about HIPAA for many years. Recently, however, the field is growing even more complicated. Companies must deal with law in and out of HIPAA. What's out of HIPAA is growing enormously. How we define "health information" is changing regularly. And a new range of laws–mostly at the state level–are creating new challenges and complexity and confusion for health care companies or any companies that use health care data. This session will explore this growing complexity and identify some of the most substantial compliance challenges that are emerging.

• What is AI?
• Why do we care?
• How is AI affecting the practice of law?
  • Discovery, document review, contract analysis and due diligence
  • Legal document generation
• How will AI affect our clients? How are healthcare stakeholders using AI?
• Ethical issues
  • Rules and formal ethics opinions

Applying for Legal Ethics credit for this session. 

Live stream for virtual attendees. 

On the surface, the concepts behind the Discount Exception and Safe Harbor seems pretty simple. The government wants to encourage price competition and to make sure that it is getting the benefit of such competition. However, as you peel back the layers, there are differences between the Discount Exception and the Discount Safe Harbor. A recent Federal District Court Decision (US ex rel. Schroeder v. Hutchinson Regional Medical Center) dug deep into the minutia of the Discount Exception and Safe Harbor. The Supreme Court’s Loper Bright decision has opened the door to a challenge to the Discount Safe Harbor. All the while, discounts are woven into the fabric of the health care industry. This session will dive deep into the Discount Exception and Safe Harbor. We will then have an interactive discussion of several hypotheticals to help elucidate the guidance and the risks. We will discuss:

• The scope and differences between the Discount Exception and Safe Harbor
• Recent cases and guidance
• Whether Supreme Court’s Loper Bright decision may lead to a challenge to the Discount Safe Harbor
• Hypotheticals to tease out the risks posed by discounts

Live stream for virtual attendees. 

This session will deliver practical advice from an experienced panel on the “dos and don’ts” of responding to government enforcement agency inquiries. Avoiding missteps in the response to a government inquiry is critical to minimize the impact on the organization's operations. This session will address the following scenarios:

• Responding to different government methods of investigation, including CIDs, grand jury subpoenas or the execution of search warrants
• Conducting parallel internal investigations or self-audits
• Ensuring appropriate use of attorney-client privilege during investigations
• The importance of collaborating and cooperating with government agents

• The changes to CMS and OIG guidance on use of sampling and extrapolation for self-auditing
• Key challenges to raise in defending an extrapolated overpayment in contractual and administrative appeals
• The changes in federal law as a result of current litigation on government payors
• How generative artificial intelligence (gAI) is anticipated to impact the use of sampling and extrapolation and potential challenges to the evidence that gAI programs produce in reimbursement disputes

Live stream for virtual attendees. 

• Ongoing Compliance Requirements for VBEs–Overview of monitoring requirements governing value-based enterprises (VBEs)/value-based arrangements (VBAs), including those set forth in the Anti-Kickback Statute safe harbors and the Stark Law exceptions. Discussion of how these requirements impact compliance obligations for value-based arrangements
• How Compliance for VBAs Differs from Traditional Physician Arrangements–Comparison of the prospective nature of monitoring compliance for VBAs versus the upfront compliance evaluation done for traditional physician arrangements
• Preparing for Compliance Monitoring Before Developing a VBE–Establish a compliance framework before developing a VBE, including defining key risk areas, setting baseline metrics, and ensuring data-sharing capabilities. Conduct due diligence on regulatory obligations and create clear contractual compliance requirements for all participants
• Immediate Compliance Actions Upon Entering a VBA–Implement real-time monitoring systems, establish reporting structures, and train all stakeholders on compliance protocols. Conduct an initial risk assessment to identify vulnerabilities and ensure alignment with AKS and  Stark requirements
• Best Practices and Tools for Effective Compliance Monitoring–Utilize data analytics, automated auditing tools, and regular self-assessments to track compliance in real time. Establish a compliance committee, structured workflows, and routine reporting mechanisms to ensure consistent oversight and accountability
• Risks of Inadequate Monitoring and Corrective Actions–Failure to monitor compliance can lead to regulatory violations, significant financial penalties, and reputational damage. If issues are identified, conduct an internal review, implement corrective action plans, and engage legal counsel to mitigate risk and maintain program integrity

Live stream for virtual attendees. 

• As to FCA falsity, is objective falsity still a defense post-Supreme Court decision in Schutte and when can opinions be false? 
• As to FCA knowledge, how have courts applied FCA knowledge post-Supreme Court decision in Schutte? 
• Under the FCA’s reverse false claims provision, when does a defendant knowingly and improperly retain an overpayment? 
• What is the latest FCA / AKS cases addressing circuit split on but-for causation and addressing the issue of under what circumstances percentage-based payments to independent contractors can run afoul of the AKS / FCA?
• What is the latest case law developments regarding the constitutionality of the qui tam provisions to the FCA?

Live stream for virtual attendees. 

• Myths about the fraud & abuse risks involved in operating a 340B Program
• Examples of false claims and kickbacks in the 340B Program (including public enforcement actions)
• Best practices for in-house legal teams to identify and review 340B arrangements with potential for F&A risks
• How to prevent fraud & abuse risks in 340B arrangements
• How to manage suspected 340B-related fraud & abuse situations

Live stream for virtual attendees. 

As scrutiny intensifies around financial arrangements between health care providers and the pharmaceutical industry, compliance leaders and health care attorneys must develop a robust, defensible approach to commercial reasonableness (CR) and fair market value (FMV). Regulators and enforcement agencies, including CMS, HHS-OIG, and the DOJ, continue to refine CR and FMV expectations, leading to evolving legal interpretations and increased enforcement activity. This session will discuss:

• Regulatory history, agency guidance, and recent high-profile settlements to compare and contrast CR from FMV as distinct concepts and to extract key insights and practical strategies
• In-depth legal, operational, and risk-based framework for ensuring that financial relationships—ranging from physician compensation to pharma-provider contracts—are commercially reasonable and within FMV
• Proactive compliance program design, detailing how to structure oversight mechanisms, conduct risk assessments, and document CR and FMV defensibly to mitigate legal exposure and protect against enforcement actions

Live stream for virtual attendees. 

Artificial Intelligence is part of our everyday life and it continues to grow and expand in its applications in healthcare at a fast pace. This session will discuss:

• How AI in health care is growing and how it is being regulated, or not regulated
• Risk areas such as coding, diagnosis, and patient care impact, including ambient listening and authorizations
• Enforcement areas, including privacy, patient care, and deceptive marketing
• Considerations for setting up compliance monitoring that is specific to AI to help establish due diligence and avoid allegations of reckless disregard for AI risks

• Navigate Emerging Fraud Risks–Stay ahead of evolving enforcement trends, including DEA enforcement, False Claims Act cases, billing integrity, and whistleblower activity in pharmacy and life sciences.
• Strengthen DEA Compliance and Prevent Diversion–Learn how to proactively manage controlled substances and reduce risk of DEA audits through best practices in DEA inspection readiness and anti-diversion process enhancements
• Enhance Recordkeeping and Billing Accuracy–Identify common DEA recordkeeping issues, coding pitfalls, PBM relationships, and compliance risks to ensure error-free Medicare, Medicaid, and private payer claims
• Best Practices–Learn how proactive risk management can enhance patient safety, operational efficiency, and regulatory trust
• Prepare for 2025 Compliance Shifts–Gain insight into anticipated legislative changes, enforcement priorities, and new compliance technologies shaping the future of DEA enforcement and fraud prevention in pharmacy and life sciences

Live stream for virtual attendees. 

Fraud and abuse enforcement remains a top priority for the federal government—but in a new administration, the rules of engagement are shifting. This dynamic panel will explore how evolving policy priorities under the Trump administration are reshaping the fraud and abuse landscape for healthcare and life sciences organizations. From the administration’s growing scrutiny of DEI programs, its expanded use of the False Claims Act as a tool for enforcement, to broader shifts in immigration policy, international collaboration, and academic operations, we’ll explore how these priorities are fueling new and evolving risks. Attendees will gain practical insights into:

• The latest developments and enforcement trends in fraud and abuse enforcement
• The impact of the administration’s DEI-related policies on False Claims Act enforcement
• Specific compliance challenges facing academic medical centers, health care organizations, and life sciences companies
• How to assess and mitigate institutional exposure in today’s uncertain regulatory environment

Live stream for virtual attendees. 

• Health care settlements and compare and contrast government-initiated cases vs. relator-initiated cases
• Compare the various self-disclosure requirements and benefits of the various regulatory agencies (i.e. OIG and DOJ)
• Understanding the risks of not investigating, remediating, and self-disclosing issues
• Conducting an internal investigation to fully identify the issue, compliance failures, and required remediation
• Factors to consider before an organization self-discloses

The health care industry thrives on data. This data–most of it about people–is heavily regulated. We have known about HIPAA for many years. Recently, however, the field is growing even more complicated. Companies must deal with law in and out of HIPAA. What's out of HIPAA is growing enormously. How we define "health information" is changing regularly. And a new range of laws–mostly at the state level–are creating new challenges and complexity and confusion for health care companies or any companies that use health care data. This session will explore this growing complexity and identify some of the most substantial compliance challenges that are emerging.

Live stream for virtual attendees.