Schedule

• Health Equity and Access (telemedicine updates)
• Reproductive Health (post-Dobbs) and patient care issues (EMTALA and clinical research updates)
• False Claims Act case law and settlements (key cases and enforcement trends)
• Stark and Anti-kickback developments
• Trends in Health Care Transactions
• Hot HIT developments (artificial intelligence, cyber-attacks and system interruptions, OCR enforcement and state laws)
• Drug price litigation and the future of Chevron deference
• Reimbursement trends and 340B
• Antitrust highlights
• And much more!

• This presentation will be in an interactive “JEOPARDY” format that will provide a fun, informative format for the discussion of legal ethics for the health care attorney

• Contestants will answer and discuss legal ethics questions, hypotheticals and dilemmas posed by our host related to:  

  • Ethical considerations for external counsel

  • Ethical considerations for in-house attorneys

  • Conflicts if interest and much, much more!

Please join former AHLA President Rob Niccolini for a wide-ranging “fireside chat” with Jocelyn Samuels, Vice Chair of the Equal Employment Opportunity Commission (EEOC). Topics to be discussed include:

• Employer DEI Initiatives after SCOTUS’s 2023 Affirmative Action Decision
• The Workplace Impact of Artificial Intelligence and other Developments in Technology
• Accommodation and Anti-Discrimination Requirements of the Pregnant Workers Fairness Act
• Future Strategic Enforcement Initiatives at the EEOC

• Is the expansion of the role of Private Equity in the health care industry a positive or a negative?
• Why is the government focusing on Private Equity Investments in health care?
• What factors increase the risk of government scrutiny of Private Equity role in a health care enterprise.
• Why types of actions/investments in Private Equity are likely to garner media attention?
• Antitrust scrutiny of Private Equity investments in health care?
• Increase in Physician Unionization

• A panel discussion with former OIG attorneys who are now advising stakeholders across the industry on patient engagement and social determinants of health
• How stakeholders can offer valuable tools and supports directly to patients to improve care coordination and encourage patient engagement in value-based care
• How to manage risks under the Anti-kickback Statute and the Beneficiary Inducements Civil Monetary Penalty Law
• OIG’s safe harbors and exceptions in the areas of beneficiary transportation, promoting access to care, value-based arrangements, and patient engagement
• OIG’s web of advisory opinions and FAQs regarding gifts of nominal value, cash incentives, gift cards, and digital health tools

• Current disputes with payers, such as issues regarding medical necessity denials, 340B drugs, and antitrust issues
• Key contract provisions that can affect dispute resolution rights
• Suggestions for building a record for arbitration
• Considerations in remaining in-network or going out of network, including No Surprises Act implications
• Tips on how to prevent provider/payer disputes from occurring

This session will focus on one of the biggest challenges facing hospitals and health systems: Complex patient discharges. Presented by both in-house and outside counsel, this session will share practical ways to address these challenging situations. Topics will include:

• The scope of the problem and what populations are most impacted, including a discussion of the impact on behavioral health, elderly, and pediatric patients
• How patients end up stuck in hospitals, including a discussion of EMTALA, safe discharge planning, civil commitment, and other causal factors
• What barriers prevent discharges and the consequences of long lengths of stay
• Statutory and regulatory compliance issues and oversight by federal and state agencies
• Litigation and legislation aimed at removing barriers and creating long-term solutions. Practical, creative, and innovative strategies to reduce lengths of stay and address gaps in the continuum of care, including legal solutions

• How alternative substances are being looked at as emerging therapies in health care delivery, including the rise in use of ketamine and the rise in interest to use psilocybin, MDMDA and other psychedelic substances in healthcare delivery models
• The federal Controlled Substances Act and that status of each drug as it relates to a corresponding schedule and the legal significance that plays
• Corporate Practice of Medicine Considerations, Informed Consent considerations and other liabilities attendant to this practice area
• Physician Involvement in the recommendation of cannabis, kratom, psilocybin or prescribing of ketamine off – label, which is becoming more prevalent; What are the licensure, malpractice and other issues and considerations to address with physicians, physician groups and healthcare facilities who/which are considering permitting such substances to be used, possessed, administered or stored on the facility premises
• The clinical trials and clinical research conducted in the area of psychedelics and the role the findings and results from such trials and research play in the discussion regarding potential health plan coverage
• Interest of Private Equity in Emerging Therapies and what type of Alternative Alignment Strategies exist for Physician Practices to partner with Private Equity

With the release of the final Merger Guidelines at the end of 2023, the federal antitrust agencies have staked out a broad and aggressive approach to antitrust enforcement, with many of the new principles upping the ante for health care transactions. This panel will examine the prospects for health care mergers in the new age of antitrust enforcement, and address questions such as:

• What are the key merger enforcement principles that now apply to health care transactions?
• How have the standards changed for considering mergers of direct competitors or potential competitors?
• What new kinds of transactions will attract attention–including vertical integration, serial transactions, private equity acquisitions, and transactions that cross market boundaries
• How have the new theories played out in recent enforcement actions against health care and other transactions

• Why did OIG issue the general compliance program guidance (“GCPG”) and how will future industry-specific CPGs (“ICPGs”) fit into OIG’s compliance program guidance revamp?
• What are the key features of the GCPG?  Why were certain topics chosen?
• What are some important substantive points that OIG would like to highlight? 
• What’s new - what does OIG address for the first time in the GCPG?
• How can compliance officers, health law attorneys, and entities participating in the health care industry best use this resource and ICPGs?
• Q&A with audience members

• A focus on the physician self-referral law (“PSL” also commonly referred to as the Stark Law) that features the Director of the Division of Technical Payment Policy (“DTPP”) at CMS, a current law firm practitioner (who was a former member of DTPP), and an in-house counsel leader for one of the largest community based health systems in the Pacific NW. The panelists will offer their thoughts surrounding PSL compliance and best practices from a government, law firm, and health system perspective
• Common pitfalls surrounding compliance with the PSL, including areas that are being seen from a private practice perspective and more importantly, by the regulators
• Commonly misunderstood aspects of PSL compliance and how to better advise your organization to avoid risk from non-compliance
• Aspects of the PSL that are more “liberal” than may be understood by many stakeholders and how to navigate relevant exceptions, and how to apply the PSL to take full advantage of these potential flexibilities
• Hypotheticals and other techniques will be used to explain the discussed concepts and to provide attendees with real world application of the PSL

• A brief background on the market realities and policies motivating passage of the Hospital Price Transparency Rule, Transparency in Coverage Rule, and the No Surprises Act
• The current facility, provider, and insurer requirements under the laws, including interim and final rules and subregulatory guidance
• Agency enforcement efforts to date
• Lessons learned and best practices for insurers, facilities, and providers to ensure ongoing compliance and readiness under the laws now that agency grace periods for compliance have lapsed
• Trends and issues underlying delayed implementation, as well as proposed rules from the agencies for these three related, but distinct, regulatory schemes

Health care privacy used to be relatively straightforward - you learned HIPAA and that was enough. But, in recent years, we are seeing more and more situations where HIPAA does not work, or does not apply at all, and as a result health care privacy is becoming an increasingly complicated area, with important implications for both consumers and businesses and enormous strategic challenges for the health care industry. These developments also are proceeding in an unconnected and ad hoc fashion, raising real concerns about the impact of these developments on the overall health care system. This session will explore why these new challenges are arising, where they are having the most impact, and will evaluate potential options for "fixing" these problems.

• Select state level approval processes for health care transactions, including those for the review and  justification of the transaction by way of a public filing with the State Attorney General
• Examples of past transactions that went through regulatory scrutiny and focus of those review processes
• The importance of a structured process and intentional education and guidance to stake holders when contemplating a change of control transactions
• Case studies, based on actual transactions, to provide guidance to attorneys and advisors of not-for-profit health systems considering a change of control transaction
• The fiduciary duties of the leadership team, the Attorney General Filing process, and address frequently asked questions related to the analysis of community benefits and determination of the fair market value of the transaction

This session will use a fun, game-show format to explore how health care organizations should respond to potentially non-compliant activity.

• Speakers from CMS, OIG, and private practice will examine several hypothetical situations and offer suggestions on how best to respond.
• Through the use of the hypotheticals, we will discuss the various options and risks associated with them:
  • Fix it–We will discuss whether it is possible to simply fix the issue going forward without the need for remediating any past activity.
  • Disclose it–We will consider whether it is necessary to disclose the past activity as well as the who, what, when, where, and how of disclosing it.
  • Pretend it didn’t happen–We will discuss whether it is possible to ignore past, non-compliant activity and what the risks of doing so are

• Health care entities, including health systems and payers, have continued to be the target of class action lawsuits.  For instance, numerous cases have been filed against payers alleging violations of the Mental Health Parity act, and litigation over pixel tracking technology has been rampant against health systems
• These cases can present significant financial risk, especially when statutory damages exist that are untethered to actual damages. In addition to the financial risk, these cases create extensive operational impacts on these organizations as they defend them
• This session will examine the emerging areas of class action lawsuits against health care entities, including in AI, data privacy, ERISA, and other areas
• The Panel consists of experienced health care and class action attorneys and they will focus on identifying the emerging areas, discussing the key issues in dispute, and discuss best practices for defending against these lawsuits and mitigating the organizational impact

This session will cover how lawyers can help their clients identify opportunities to innovate, either directly or through partnerships with third parties, including the following:

• Data and intellectual property strategies
• Key issues in working with startups, innovators, and inventors
• Joint development and licensing agreements
• Best practices in governance and employee policies/agreements for encouraging innovation
• Compliance issues relating to innovation (IP, reimbursement, licensure, etc.)
• The future of AI-driven innovation
• This session will also discuss exciting innovations and developments in FemTech to illustrate how lawyers can partner with their clients to help advance innovation.

• Terminology for primary and gender affirming care for transgender and gender nonbinary people, including brief discussion of Standards of Care for Transgender and Gender Diverse people, Version 8, as background
• Gender affirming care and HIPAA–the basics
• Gender affirming care and minor health care consent rights under state law, how it relates to privacy
• State quality improvement/assurance laws, which permit sharing de-identified information and PHI about shared transgender patients among organizations
• Patient Safety Organizations and Quality Improvement models that allow collaboration on best practices for transgender health care
• State AGOs seeking information about primary or gender affirming care, or asking for increased protections on the same / related trends

This session will provide background and the genesis of behavioral health laws and regulations to give participants context and background for understanding current SUD confidentiality laws and regulations. Various behavioral health laws and regulations will be addressed including:

• Highlighting the newly-issued Final "Confidentiality of Substance Use Disorder Patient Records” under 42 CFR Part 2 that were published this year
• Diversion programs to avoid justice system involvement for those needing treatment and services
• Presenters will provide their thoughts and insight on future changes expected within the system
• The session will be provided in an engaging and lighthearted format using a play on the film “Austin Powers – International Man of Mystery” and its groovy vibe to impart information and analysis on mental health and substance use disorder laws and regulations

• What are the current delivery system reform goals of the Biden Administration and how have those changes from past Administrations?
• Current Models, successes, and failures (this would be discussion of what models have “worked”, what models have not seemed to work, and an analysis of “why” some are more successful than others
• Are we going to see all Medicare beneficiaries in VB models by 2030? If so, how is that going to be accomplished? Are we “on track”? What is the status of the objectives of CMMI’s Strategy Refresh?
• Success, or lack of success in VBC from the commercial insurance/private payer side and state-based activity
• Practical barriers to smaller hospitals and systems entering VBC- How do they overcome them (and a discussion of health care delivery equity impacts)
• What are the opportunities and challenges with the current Medicare model portfolio?

• Crafting bylaws to your advantage: Key insights and practical tips on how to best use the Medical Staff Bylaws to your health care entity’s advantage to avoid costly litigation or protracted peer review processes, as well as how to acclimate new Bylaws to your medical staff
• Providing fair hearings: Lessons learned from peer review hearing experiences, guidance on how to prepare for a successful and cost effective hearing and appeal process, and how to best avoid a lawsuit
• Delegated credentialing: While vital to a health care entity’s bottom line, delegated credentialing is often misunderstood. Our session will address the purpose and importance of delegated credentialing and how to approach the topic when there are changes to your organization

• Is the expansion of the role of Private Equity in the health care industry a positive or a negative?
• Why is the government focusing on Private Equity Investments in health care?
• What factors increase the risk of government scrutiny of Private Equity role in a health care enterprise.
• Why types of actions/investments in Private Equity are likely to garner media attention?
• Antitrust scrutiny of Private Equity investments in health care?
• Increase in Physician Unionization

• Summary and overview of "both sides of the house": (1) Clinical performance review and interventions (including Peer Review protections and Hospital Bylaws) and (2) Human Resources policy/protocols
• How physician performance issues often overlap both clinical performance and behavioral (HR) policies, which implicates both processes
• The risks and benefits associated with each path of discipline/intervention (from both Physician/Provider and Employer perspectives), including reporting obligations
• Practical strategies for navigating the risks and benefits

As health systems continue to become more complex in their operating models, the responsibility of their Board of Directors has continued to grow. This session will focus on emerging trends in the health care governance space and will build upon the guidance provided in the popular AHLA governance podcast series hosted by the panelists. The topics that will be covered include:

• The evolving duties of a Board member in light of recent case decisions in Delaware, other jurisdictions and other model rules
• The expanding fiduciary responsibilities of Board members as they govern workforce, clinical services and financial sustainability
• The recruitment strategies of leading health systems as they look to ensure Board diversity
• Insights into the function of Board Committees and how they assist Boards with their expanding agendas and areas of oversight
• Emerging areas of governance oversight including enterprise risk management, ESG, AI technology and other areas of focus

This presentation will examine recent developments in False Claims Act enforcement and jurisprudence, from the perspectives of both the DOJ and of the defense bar. Topics will include:

• Retrospective on how the Fraud Enforcement Reform Act (FERA) revisions to the FCA affected enforcement over the past 15 years
• Recent SCOTUS guidance regarding scienter and DOJ dismissals of declined cases
• Recent case law developments regarding the causal connection required between kickback violations and false claims
• Other key legal developments/hot topics under the FCA, including EKRA as a potential basis for FCA liability
• Current DOJ enforcement priorities under the FCA

• United States Core Data for Interoperability (USCDI) and USCDI+, including a discussion of the Behavioral Health IT Initiative
• Trusted Exchange Framework and Common Agreement (TEFCA), including the new Common Agreement 2.0 and future milestones
• Information blocking regulatory updates, including new terms and exceptions
• Artificial Intelligence (AI) requirements for health IT developers under the ONC Health IT Certification Program
• Regulatory developments expected in the HTI-2 proposed rule, including provisions on public health IT certification, electronic prior authorization, and patient engagement
• Potential finalized health care provider disincentives for information blocking

This panel of experienced AHLA Dispute Resolution Service neutrals will share their perspectives on arbitrating payer/provider disputes in terms of what works, what doesn’t, and how to best persuade the decisionmaker in your case. The panel will be moderated by an experienced litigator and jurist who has led and supervised hundreds of payor/provider arbitrations, and is also a member of the Dispute Resolution Service Council that recently updated AHLA’s Commercial Arbitration Rules to better address payor/provider disputes. The panel will discuss the following key issues in payor/provider arbitrations:

• Best practices for handling large volumes of claims such as sampling and bellwether hearings
• Best practices for dealing with expert witnesses from reports to testimony
• Key motions that are commonly filed in a payor/provider dispute including dispositive motions
• Best practices for remote or hybrid hearings
• Best (and worst) practices by counsel
• Optimizing arbitration clauses

• Operational concerns and solutions to consider if under an audit for Medicare, Medicaid or a commercial payor
• Strategies for handling different audits, e.g., a UPIC audit resulting in a payment suspension, a multi-level TPE audit or commercial pre-pay audits
• Tactics outside of the appeal or ADR process, e.g., negotiation of payment plans, seeking intervention of government officials

• The rules of professional conduct implicated by the use of modern technology in lawyering, encompassing social media, artificial intelligence, and text messaging
• A representative sampling of bar association guidelines and enforcement actions highlighting the risks of misusing technology
• Tips for leveraging technology to advance your career, including LinkedIn best practices and appropriate uses of AI

• While U.S. health care sector organizations are aware of their legal obligations under the Health Insurance Portability and Accountability Act (HIPAA), they may be less aware of other consequential cybersecurity and data security regulations and industry standards
• New and recently updated regulations and standards such as the Securities and Exchange Commission’s (SEC) Final Rule on Cybersecurity Risk Management, Strategy, Governance, and Incident Disclosure, the Payment Card Industry Data Security Standard (PCI DSS), and the Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA)
• Beyond existing regulations and standards, this session will consider the future of cybersecurity regulations and consider approaches to move from static security assessments (such as those required by HIPAA and state level regulations) to dynamic security assessments
• Best practices for health care entities in an ever-evolving digital threat landscape, including how to protect digitals assets and mitigate the impact of a cybersecurity event on operations

Reimbursement Issues

• Current State of Extensions of Telehealth Waivers and Flexibilities

• Payment/Place of Service for Telehealth Services

• Virtual Direct Supervision of Services Incident to Physicians’ or Practitioners’ Professional Services, Diagnostic Tests, and Certain Other Hospital Outpatient Services

• Virtual Supervision of Residents in Teaching Settings

• Remote Services Furnished by Outpatient Departments

• Enrollment and Interjurisdictional Reassignment Issues

• Payment Policies for Remote Physiologic and Therapeutic Monitoring

• Payment Policies for Other Remote Services: Interprofessional Consults/eConsults, E-visits, and Virtual Check-ins, and Remote Evaluations

Operational Considerations and Exemplary Arrangements

• State Law Issues and Interstate Telehealth Arrangements

• Key Areas Where Providers are Using Telehealth Services

• Stakeholder Input on Rulemaking/Legislation

• Issues Related to Operationalizing Remote Physiologic and Therapeutic Monitoring

• A Look Toward the Future of Telehealth Programs

• Practical tips for Entrepreneurial Providers

• Considerations Related to Hiring Fully Remote Physicians

Hot Topics in Telehealth Compliance and Enforcement  Recent Regulations and Rulemaking

• OIG and DOJ Enforcement Trends

• Compliance Issues Related to Contracted Telehealth Services

• Current disputes with payers, such as issues regarding medical necessity denials, 340B drugs, and antitrust issues
• Key contract provisions that can affect dispute resolution rights
• Suggestions for building a record for arbitration
• Considerations in remaining in-network or going out of network, including No Surprises Act implications
• Tips on how to prevent provider/payer disputes from occurring

• When Congress passed the Americans with Disabilities Act (ADA), it recognized that discrimination against individuals with disabilities persists in health services
• Through the ADA, Congress established a national mandate for the elimination of discrimination against individuals with disabilities by providing strong and enforceable standards
• The ADA apply to all types of health care providers, including those operated by either private entities or state and local governments, such as hospitals, nursing facilities, urgent care providers, physicians, dentists, optometrists, and durable medical equipment retailers
• The ADA applies to all aspects of health care services, including websites, telehealth appointments, electronic kiosks, and in-person medical services
• The United States Attorneys’ Offices across the nation in partnership with DOJ's Civil Rights Division have been enforcing the ADA in health care settings, including ensuring that healthcare providers furnish appropriate auxiliary aids and services for individuals with communication disabilities, such as being deaf, hard of hearing or blind, ensuring physical access to medical care for people with mobility disabilities and ensuring equal access to health care provider's websites
• This program will focus on the ADA legal principles applicable in health care settings and common issues that arise in ADA cases against health care providers

• This session will provide attendees with the tools needed to:
• Understand the scope of legal uncertainty in the Dobbs Era
• Assess the impact of legal ambiguity on clinicians and patients
• Analyze the legal risks associated with treating and counseling pregnant patients where state laws bar the provision of abortion
• Develop an institutional strategy for anticipating and managing legal risks

With the increased scrutiny on kickbacks regarding medical device, pharmaceutical, and biotech arrangements, there has been an uptick in enforcement activity specific to the use of physicians, advanced practice providers, and other health care providers serving as key opinion leaders who consult, speak, serve as advisory board members, and/or otherwise lend their expertise. Further, physician owned distributorships and other also continue to stay in the forefront of regulators minds. This session will discuss:

• Current key regulatory and compliance considerations associated with various recent medical device, pharmaceutical and other biotech settlements and describe the implications in practice
• Best practices regarding development, implementation, and maintenance of key opinion leader programs and engagement
• Risk areas and present proactive strategies for compliant physician owned distributor arrangements
• In house and external perspectives on establishing and operationalizing relationships with life sciences organizations in a compliant manner

• A panel discussion with former OIG attorneys who are now advising stakeholders across the industry on patient engagement and social determinants of health
• How stakeholders can offer valuable tools and supports directly to patients to improve care coordination and encourage patient engagement in value-based care
• How to manage risks under the Anti-kickback Statute and the Beneficiary Inducements Civil Monetary Penalty Law
• OIG’s safe harbors and exceptions in the areas of beneficiary transportation, promoting access to care, value-based arrangements, and patient engagement
• OIG’s web of advisory opinions and FAQs regarding gifts of nominal value, cash incentives, gift cards, and digital health tools

• Health care entities, including health systems and payers, have continued to be the target of class action lawsuits.  For instance, numerous cases have been filed against payers alleging violations of the Mental Health Parity act, and litigation over pixel tracking technology has been rampant against health systems
• These cases can present significant financial risk, especially when statutory damages exist that are untethered to actual damages. In addition to the financial risk, these cases create extensive operational impacts on these organizations as they defend them
• This session will examine the emerging areas of class action lawsuits against health care entities, including in AI, data privacy, ERISA, and other areas
• The Panel consists of experienced health care and class action attorneys and they will focus on identifying the emerging areas, discussing the key issues in dispute, and discuss best practices for defending against these lawsuits and mitigating the organizational impact

• Crafting bylaws to your advantage: Key insights and practical tips on how to best use the Medical Staff Bylaws to your health care entity’s advantage to avoid costly litigation or protracted peer review processes, as well as how to acclimate new Bylaws to your medical staff
• Providing fair hearings: Lessons learned from peer review hearing experiences, guidance on how to prepare for a successful and cost effective hearing and appeal process, and how to best avoid a lawsuit
• Delegated credentialing: While vital to a health care entity’s bottom line, delegated credentialing is often misunderstood. Our session will address the purpose and importance of delegated credentialing and how to approach the topic when there are changes to your organization

Health privacy professionals advising on de-identification and anonymization face a complex and evolving legal framework, including new US state privacy laws, HIPAA, GDPR, and other global laws.  In the U.S. alone, those trying to integrate de-identified health and consumer data may grapple with at least 18 different definitions. Those working with health data must additionally keep abreast of increasingly complex questions about whether genetic or biometric data are capable of de-identification or anonymization. Although the relevant standards have become more complicated, health systems and digital health companies alike increasingly seek to harness de-identified data in training generative AI and other new technologies and in performing biomedical research.

This session will discuss the divergent standards for de-identification and anonymization, along with strategies that practitioners can employ to navigate them. Attendees will leave with:

• An overview of de-identification standards in state privacy laws
• A comparison of U.S. state law interpretations of de-identification with HIPAA and GDPR standards
• A framework for applying HIPAA de-identification standards, including their application to genomics and AI activities
• An understanding of recent developments in the EU and UK regarding anonymization and pseudonymization

• This interactive session is designed to take a step-by-step approach to evaluating a typical or standard set of representations and warranties that are often present in health care transactions
• The types of issues that are covered by health care specific representations and warranties of the buyer and seller or the lender and borrower in mergers, acquisitions, and debt transaction documents
• Why a set of general representations and warranties inclusive of a general compliance with laws representation is not enough to adequately address risk in health care transactions
• When and how qualifiers like “knowledge” or “materiality” may or may not be appropriate and how each side of a transaction may seek to negotiate qualifiers as well as the necessity for “materiality scrapes”
• How health care representations and warranties are connected to indemnities in transaction documents as well as how the parties to transactions address survival of the terms
• How buyers / lenders often use representations and warranties as a form of due diligence and how due diligence itself can and does inform the negotiation over representations and warranties

• A focus on the physician self-referral law (“PSL” also commonly referred to as the Stark Law) that features the Director of the Division of Technical Payment Policy (“DTPP”) at CMS, a current law firm practitioner (who was a former member of DTPP), and an in-house counsel leader for one of the largest community based health systems in the Pacific NW. The panelists will offer their thoughts surrounding PSL compliance and best practices from a government, law firm, and health system perspective
• Common pitfalls surrounding compliance with the PSL, including areas that are being seen from a private practice perspective and more importantly, by the regulators
• Commonly misunderstood aspects of PSL compliance and how to better advise your organization to avoid risk from non-compliance
• Aspects of the PSL that are more “liberal” than may be understood by many stakeholders and how to navigate relevant exceptions, and how to apply the PSL to take full advantage of these potential flexibilities
• Hypotheticals and other techniques will be used to explain the discussed concepts and to provide attendees with real world application of the PSL

Health care privacy used to be relatively straightforward - you learned HIPAA and that was enough. But, in recent years, we are seeing more and more situations where HIPAA does not work, or does not apply at all, and as a result health care privacy is becoming an increasingly complicated area, with important implications for both consumers and businesses and enormous strategic challenges for the health care industry. These developments also are proceeding in an unconnected and ad hoc fashion, raising real concerns about the impact of these developments on the overall health care system. This session will explore why these new challenges are arising, where they are having the most impact, and will evaluate potential options for "fixing" these problems.

This presentation will examine recent developments in False Claims Act enforcement and jurisprudence, from the perspectives of both the DOJ and of the defense bar. Topics will include:

• Retrospective on how the Fraud Enforcement Reform Act (FERA) revisions to the FCA affected enforcement over the past 15 years
• Recent SCOTUS guidance regarding scienter and DOJ dismissals of declined cases
• Recent case law developments regarding the causal connection required between kickback violations and false claims
• Other key legal developments/hot topics under the FCA, including EKRA as a potential basis for FCA liability
• Current DOJ enforcement priorities under the FCA

• Why did OIG issue the general compliance program guidance (“GCPG”) and how will future industry-specific CPGs (“ICPGs”) fit into OIG’s compliance program guidance revamp?
• What are the key features of the GCPG?  Why were certain topics chosen?
• What are some important substantive points that OIG would like to highlight? 
• What’s new - what does OIG address for the first time in the GCPG?
• How can compliance officers, health law attorneys, and entities participating in the health care industry best use this resource and ICPGs?
• Q&A with audience members

• Summary and overview of "both sides of the house": (1) Clinical performance review and interventions (including Peer Review protections and Hospital Bylaws) and (2) Human Resources policy/protocols
• How physician performance issues often overlap both clinical performance and behavioral (HR) policies, which implicates both processes
• The risks and benefits associated with each path of discipline/intervention (from both Physician/Provider and Employer perspectives), including reporting obligations
• Practical strategies for navigating the risks and benefits

• United States Core Data for Interoperability (USCDI) and USCDI+, including a discussion of the Behavioral Health IT Initiative
• Trusted Exchange Framework and Common Agreement (TEFCA), including the new Common Agreement 2.0 and future milestones
• Information blocking regulatory updates, including new terms and exceptions
• Artificial Intelligence (AI) requirements for health IT developers under the ONC Health IT Certification Program
• Regulatory developments expected in the HTI-2 proposed rule, including provisions on public health IT certification, electronic prior authorization, and patient engagement
• Potential finalized health care provider disincentives for information blocking

Reimbursement Issues

• Current State of Extensions of Telehealth Waivers and Flexibilities

• Payment/Place of Service for Telehealth Services

• Virtual Direct Supervision of Services Incident to Physicians’ or Practitioners’ Professional Services, Diagnostic Tests, and Certain Other Hospital Outpatient Services

• Virtual Supervision of Residents in Teaching Settings

• Remote Services Furnished by Outpatient Departments

• Enrollment and Interjurisdictional Reassignment Issues

• Payment Policies for Remote Physiologic and Therapeutic Monitoring

• Payment Policies for Other Remote Services: Interprofessional Consults/eConsults, E-visits, and Virtual Check-ins, and Remote Evaluations

Operational Considerations and Exemplary Arrangements

• State Law Issues and Interstate Telehealth Arrangements

• Key Areas Where Providers are Using Telehealth Services

• Stakeholder Input on Rulemaking/Legislation

• Issues Related to Operationalizing Remote Physiologic and Therapeutic Monitoring

• A Look Toward the Future of Telehealth Programs

• Practical tips for Entrepreneurial Providers

• Considerations Related to Hiring Fully Remote Physicians

Hot Topics in Telehealth Compliance and Enforcement  Recent Regulations and Rulemaking

• OIG and DOJ Enforcement Trends

• Compliance Issues Related to Contracted Telehealth Services

With the release of the final Merger Guidelines at the end of 2023, the federal antitrust agencies have staked out a broad and aggressive approach to antitrust enforcement, with many of the new principles upping the ante for health care transactions. This panel will examine the prospects for health care mergers in the new age of antitrust enforcement, and address questions such as:

• What are the key merger enforcement principles that now apply to health care transactions?
• How have the standards changed for considering mergers of direct competitors or potential competitors?
• What new kinds of transactions will attract attention–including vertical integration, serial transactions, private equity acquisitions, and transactions that cross market boundaries
• How have the new theories played out in recent enforcement actions against health care and other transactions

As health systems continue to become more complex in their operating models, the responsibility of their Board of Directors has continued to grow. This session will focus on emerging trends in the health care governance space and will build upon the guidance provided in the popular AHLA governance podcast series hosted by the panelists. The topics that will be covered include:

• The evolving duties of a Board member in light of recent case decisions in Delaware, other jurisdictions and other model rules
• The expanding fiduciary responsibilities of Board members as they govern workforce, clinical services and financial sustainability
• The recruitment strategies of leading health systems as they look to ensure Board diversity
• Insights into the function of Board Committees and how they assist Boards with their expanding agendas and areas of oversight
• Emerging areas of governance oversight including enterprise risk management, ESG, AI technology and other areas of focus

• The rules of professional conduct implicated by the use of modern technology in lawyering, encompassing social media, artificial intelligence, and text messaging
• A representative sampling of bar association guidelines and enforcement actions highlighting the risks of misusing technology
• Tips for leveraging technology to advance your career, including LinkedIn best practices and appropriate uses of AI

• Select state level approval processes for health care transactions, including those for the review and  justification of the transaction by way of a public filing with the State Attorney General
• Examples of past transactions that went through regulatory scrutiny and focus of those review processes
• The importance of a structured process and intentional education and guidance to stake holders when contemplating a change of control transactions
• Case studies, based on actual transactions, to provide guidance to attorneys and advisors of not-for-profit health systems considering a change of control transaction
• The fiduciary duties of the leadership team, the Attorney General Filing process, and address frequently asked questions related to the analysis of community benefits and determination of the fair market value of the transaction

This session will use a fun, game-show format to explore how health care organizations should respond to potentially non-compliant activity.

• Speakers from CMS, OIG, and private practice will examine several hypothetical situations and offer suggestions on how best to respond.
• Through the use of the hypotheticals, we will discuss the various options and risks associated with them:
  • Fix it–We will discuss whether it is possible to simply fix the issue going forward without the need for remediating any past activity.
  • Disclose it–We will consider whether it is necessary to disclose the past activity as well as the who, what, when, where, and how of disclosing it.
  • Pretend it didn’t happen–We will discuss whether it is possible to ignore past, non-compliant activity and what the risks of doing so are

This session will provide background and the genesis of behavioral health laws and regulations to give participants context and background for understanding current SUD confidentiality laws and regulations. Various behavioral health laws and regulations will be addressed including:

• Highlighting the newly-issued Final "Confidentiality of Substance Use Disorder Patient Records” under 42 CFR Part 2 that were published this year
• Diversion programs to avoid justice system involvement for those needing treatment and services
• Presenters will provide their thoughts and insight on future changes expected within the system
• The session will be provided in an engaging and lighthearted format using a play on the film “Austin Powers – International Man of Mystery” and its groovy vibe to impart information and analysis on mental health and substance use disorder laws and regulations

• What are the current delivery system reform goals of the Biden Administration and how have those changes from past Administrations?
• Current Models, successes, and failures (this would be discussion of what models have “worked”, what models have not seemed to work, and an analysis of “why” some are more successful than others
• Are we going to see all Medicare beneficiaries in VB models by 2030? If so, how is that going to be accomplished? Are we “on track”? What is the status of the objectives of CMMI’s Strategy Refresh?
• Success, or lack of success in VBC from the commercial insurance/private payer side and state-based activity
• Practical barriers to smaller hospitals and systems entering VBC- How do they overcome them (and a discussion of health care delivery equity impacts)
• What are the opportunities and challenges with the current Medicare model portfolio?

• While U.S. health care sector organizations are aware of their legal obligations under the Health Insurance Portability and Accountability Act (HIPAA), they may be less aware of other consequential cybersecurity and data security regulations and industry standards
• New and recently updated regulations and standards such as the Securities and Exchange Commission’s (SEC) Final Rule on Cybersecurity Risk Management, Strategy, Governance, and Incident Disclosure, the Payment Card Industry Data Security Standard (PCI DSS), and the Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA)
• Beyond existing regulations and standards, this session will consider the future of cybersecurity regulations and consider approaches to move from static security assessments (such as those required by HIPAA and state level regulations) to dynamic security assessments
• Best practices for health care entities in an ever-evolving digital threat landscape, including how to protect digitals assets and mitigate the impact of a cybersecurity event on operations