Schedule

Asha B. Scielzo, AHLA President, Director, Health Law & Policy Program, American University Washington College of Law
Manasa Gopal, Planning Committee Co-Chair
Kristen Kim, Planning Committee Co-Chair
Kristen McDermott Woodrum, Planning Committee Co-Chair

• Are Medicare cuts really off the table?
• Will states be able to reshape Medicaid?
• What should we expect from the Department of Government Efficiency?
• What’s the future of the ACA?

Robert G. Homchick, Davis Wright Tremaine
Kim Harvey Looney, K&L Gates
Cynthia F. Wisner, Associate Counsel, Trinity

• Reproductive Health, Health Equity and Access (including EMTALA and clinical research
• False Claims Act case law and settlements (key cases and enforcement trends)
• Stark and Anti-kickback developments
• Telemedicine and DEA updates
• Health Care Transactions (from hot antitrust topics, to the latest trends, to increased bankruptcies, to private equity, to tax issues)
• Hot HIT developments (artificial intelligence, cyber-attacks, information blocking and interoperability, OCR enforcement, and state laws)
• Price transparency updates and enforcement
• Drug Price disputes, Reimbursement trends and 340B
• And much more!

Aastha Farr, Associate General Counsel, SCAN Health Plan
Carolyn V. Metnick, Sheppard Mullin Richter & Hampton LLP

• What is AI?
• Why should we care?
• How is AI affecting the practice of law?
• Primary uses of AI in the practice of law
• How will AI affect our clients?
• Ethical Issues
• Rules and formal ethics opinions

Kristen Kim, VP, Deputy General Counsel, Chief Regulatory Counsel, Memorial Sloan Kettering Cancer Center
Heather H. Pierce, Senior Director for Science Policy and Regulatory Counsel, Association of American Medical Colleges

The international exchange of information and ideas that is critical to advancing scientific research is under increased scrutiny. Academic medical centers and their partners need to respond to warnings from US government officials about the potential national and economic security risks of access to US research information and implement specific requirements to protect the data and the research enterprise. This session will:

• Trace evolving law related to research security policy, including NSPM-33, the CHIPS and Science Act, OSTP guidance for federal agencies to implement research security requirements, proposed BIOSECURE Act, and others
• Describe four essential elements of a research security program under the OSTP Guidelines: 1) cybersecurity, 2) foreign travel security, 3) research security training and 4) export control training
• Provide updates and predictions on Federal agency activities under the new Administration
• Answer practical questions confronted by in-house counsel supporting research activities, including a discussion of balancing open science and data sharing mandates with the need to safeguard research data

Jerry Chang, BRG
Brynne Goncher, Vice President, Deputy General Counsel at Piedmont Healthcare
Thomas H. Hawk, King & Spalding

• Why JV? Market trends driving consideration of this model
• Examples of JV models and “JV – lite” models
• Key governance considerations in hospital / physician joint ventures
• Special considerations when hospital partner is an academic medical center
• What are we seeing?  Service lines frequently involved in JVs
• Regulatory considerations
• Importance of FMV support for various aspects of the arrangement
• Unique valuation considerations for JVs

Kirk Nahra, Wilmer Hale
Paul F. Schmeltzer, Clark Hill

• Ransomware continues to be a large risk for the health care sector and its service providers
• Ransomware creates not only massive privacy risk but also ongoing operational concerns
• Companies also face growing enforcement risks related to ransomware attacks
• Identify key concerns, appropriate mitigation strategies and effective techniques for preparing for and addressing ransomware attacks

Allison Cohen, Baker Donelson Bearman Caldwell & Berkowitz PC
Bradley Cunningham, Lead Policy and Regulatory Analyst, Association of American Medical Colleges
David Vernon, Hooper, Lundy & Bookman, PC

• Medicare GME reimbursement, including the factors that affect direct graduate medical education (DGME) and indirect medical education (IME) payments
• Key considerations when establishing new teaching hospitals
• Advanced discussion of GME partnerships through programs like affiliated group agreements and rural track programs
• Updates on new GME polices in the FY 2025 IPPS Final Rule
• Opportunities for hospitals training over their caps to receive new GME funding
• Practical examples of navigating GME issues and the impact of the SCOTUS Loper Bright decision

Manasa Gopal, Associate General Counsel, Columbia University
Melissa B. Levine, Hogan Lovells US LLP

We will discuss the latest regulatory and legal developments in health privacy/data sector impacting AMC's, Providers and Health Systems for 2025, including updates on the following:

• Key legal developments and initiatives, including:
  • Use of AI in health care and recent AI regulatory developments,
  • OCR and FTC positions and enforcement, and
  • State privacy laws trends and challenges.
• Key enforcement and litigation risks we are seeing and expecting to continue or increase in 2025 and practical ways to mitigate them.
• Anticipated developments as a result of the election results

Nicole Demers, Deputy Associate Attorney General, Chief of the Antitrust Section, Office of the Attorney General
Rohan Kochikar Pai, Deputy Assistant Director at Federal Trade Commission, Federal Trade Commission Bureau of Competition
John Saran, Holland & Knight LLP
Christine L. White, Deputy General Counsel, Northwell Health

• Health care M&A deals are under increasing scrutiny. A number of states have enacted or are considering new laws related to pre-closing review of health care M&A deals. 2024 was an important year, as California’s new requirements went into effect and Indiana passed a comprehensive law. Meanwhile, five other states failed to pass similar legislation that would augment existing laws
• In addition to heightened state scrutiny of health care deals, federal regulators have increased their scrutiny of health care M&A deals by proposing legislation that would scrutinize private equity investments. The FTC and DOJ have also focused on roll-up strategies and platforms that have significant market concentration. Counsel need to prepare for the impact of the new requirements when considering the timelines for transactions in 2025 as well as the uncertainty created by the additional review and oversight
• Our discussion will guide health care counsel on the recent reporting requirements for parties involved in healthcare M&A deals. The panel will examine the state legislative activity related to scrutiny of health care M&A deals and will discuss how the new laws are changing the playing field. The panel will address the considerations those involved in health care deals need to keep in mind and will offer best practices for navigating the new requirements
• After our presentations, we will engage in a live question and answer session with participants so we can answer your questions about these important issues directly

Anthony J. Burba, Barnes & Thornburg LLP
Ted Lotchin, EVP/Chief Compliance Officer, UNC Health

This panel will discuss the key compliance risks and opportunities facing the health care industry heading into 2025. Panelists will include senior in-house counsel, the Chief Compliance Officer of a large academic and community health system, and experienced outside counsel. The conversational and interactive format will provide different perspectives on key issues facing the industry, including:

• State and federal enforcement priorities for providers and managed care organizations
• DOJ focus on private equity investment in health care
• Continued evolution of self-disclosure priorities
• Benchmarking compliance programs against OIG and DOJ requirements
• Managing risks created by vendors and other third parties

Tynan O. Kugler, PYA, PC
Danyale Phillips, Associate General Counsel, Office of the General Counsel, Virtua Health
Andrea W. Weaver, deLemos & Wever, PLLC, Charlotte, NC

Increasingly, physician practices have joined hospitals, health systems, and academic medical centers to offer clinical trials to contribute to medical research and innovation, to improve patient care, and to advance various strategic and operational goals. However, establishing and managing compliant and financially feasible clinical trials can be challenging for organizations trying to offer cutting edge treatments and grow alternative revenue streams amid an intricate legal and regulatory landscape. The session will discuss:

• Current regulatory challenges in clinical trials and describe the implications in practice
• Nuanced risk areas and present proactive strategies for managing complex regulatory compliance, contractual, and risk management issues
• Best practices for optimizing financial outcomes in clinical trials including the importance of negotiating budgets that cover trial-related expenses as part of the contracting process
• Contemporary approaches for managing conflicts of interest and share real world insights to appropriately maintain the integrity of research
• Notable case studies to illustrate key takeaways

Michelle Garvey Brennfleck, Buchanan Ingersoll & Rooney PC
Katherine Miler Schilling, Managing Regional Associate General Counsel, University of Michigan

• AMCs are more frequently affiliating with community hospitals and health systems
• Such affiliations may be supported–or even suggested–by state regulators, such as state Attorneys General, that are interested in ensuring that community members have high quality medical care within their communities
• Though potentially financially challenging, affiliating with community hospitals may be desirable for AMCs seeking to shift lower acuity patients to more appropriate community-based settings and to provide varied training environments for residents and students
• AMCs that are state subdivisions may benefit from reduced antitrust scrutiny under the state action doctrine, along with the different competitive position of AMCs and community hospitals (with AMCs historically providing quaternary care and community hospitals historically providing tertiary care)
• In addition to standard transactional and integration considerations, AMCs and community hospitals must carefully consider faculty and medical staff integration, related compensation and regulatory considerations, cultural differences, and how and when to extend the educational and research missions beyond the AMC

Jacqueline C. Baratian, SVP & Chief Compliance and Privacy Officer, Kaiser Permanente
William (Bill) Mathias, Bass, Berry & Sims
Kenya Woodruff, Katten Muchin Rosenman LLP

The goal of this session is to get the audience involved and to provide practical, real-world discussion of how to diffuse compliance landmines. This is an advanced session that will use hypotheticals to explore ways in which conduct that initially looks problematic may not actually be a problem. We will also use the hypos to discuss the ins and outs of:

• Analyzing situations to identify if there is actually a problem
• Taking corrective action
• If necessary, making a disclosure

The hypos will cover a variety of different compliance issues effecting hospital, physicians, and AMCs, including AKS, Stark, exclusion/licensing, and various billing issues.

Christy Cawthon, Vice President, Medical Economics and Contract Performance, Southwestern Health Resources
Mara McDermott, CEO, Accountable for Health
Brian R. Stimson, Arnall Golden Gregory LLP

• Session description to follow

Steven E. Gordon, Retired, Civil Rights Enforcement Coordinator, Assistant United States Attorney, Eastern District of Virginia

The Americans with Disabilities Act (“ADA”) prohibits discrimination by covered entities, including health care providers, such as academic medical centers, hospitals, and physicians. 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. Cases have included enforcement actions against health care providers for failing to provide appropriate auxiliary aids and services for individuals with communication disabilities, such as being deaf and hearing loss, 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, common issues that arise in these cases, DOJ enforcement efforts, including an exploration of actual cases against health care providers.

David J. Peloquin, Ropes & Gray
Alexandra A. Royal, Legal Counsel, Mayo Clinic

While the United States has not historically restricted the transfer of personal data outside the country, the past few years have seen the emergence of several limitations on cross-border data flows.  On January 8, 2025, the Department of Justice issued a Final Rule entitled “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons.”  The Final Rule places limitations on the sharing of several categories of sensitive personal data with the People’s Republic of China (“PRC”) and other countries of concern, as well as covered persons with ties to such countries of concern.  Notably, the Final Rule applies regardless of whether the data in question have been de-identified, pseudonymized or anonymized.  Given its expansive scope, the rule is likely to have major implications for academic medical centers (“AMCs”), health systems and universities that maintain research collaborations or other affiliations with entities located in the PRC and other countries of concern.  In a similar vein, in June 2024, the Protecting Americans’ Data from Foreign Adversaries Act (“PADFAA”) took effect.  PADFAA restricts certain data brokerage activities involving the PRC and other foreign adversary nations.  At the state level, recent years have seen the enactment of legislation that restricts the offshoring of patient data.

This session will provide an overview of these recent legal developments, address implications for AMCs, health systems, and universities, and offer practical strategies for coming into compliance.

Meri Gordon, Polsinelli
Courtney Grande, Senior Corporate Counsel-Managed Care,Community Health Systems (CHSPSC, LLC)

• Session description to follow

Daniel Cody, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, PC
Jonathan A. Porter, Husch Blackwell LLP

• Statistical analysis of trends in civil False Claims Act litigation and other health care industry enforcement litigation
• Health care fraud enforcement priority areas including anti-kickback statute, Stark Law, managed care, COVID-19 relief funds, and private equity
• Overview of federal and state agency guidance and policy developments including benefits of self-disclosures and whistleblower pilot programs
• Collaboration across federal agencies in health care enforcement

Gerald (Jud) E. DeLoss, Chief Executive Officer & Chief Legal Officer, Illinois Association for Behavioral Health
Eric Neiman, Epstein Becker Green

Ambulance transport is a critical part of the US health system, involving tens of millions of emergency transports annually. The industry has experienced many of the same challenges as other parts of the inter-connected acute care health system in recent years: Overwhelming demands during the pandemic, staffing shortages, behavioral crises in the community, struggles to deliver care in rural, and underserved communities. This presentation will provide an update on legal issues affecting ambulance transport and other aspects of emergency medical services. Topics include:

• Federal regulatory update and state law trends
• Staffing shortages and proposed solutions
• Wall time: Challenges at the emergency department interface and EMTALA
• Emergency responders and law enforcement
• Mobile crisis response and other alternatives for behavioral emergencies
• Ambulance deserts: Emergency medical services in rural and underserved areas

Hilary Buckley Domeika, Division Senior Corporate Counsel, Providence St. Joseph Health
Alissa D. Fleming, Baker Donelson

This session will address the challenges associated with medical staff issues involving medical necessity. It will also explore the unique relationship, interaction between, and actions taken by the hospital medical staff and the employer of the physician. In-House counsel and outside counsel for the medical staff and employer will share their unique perspectives, experiences, and insights working through these issues. This session will discuss the following topics:

• How to approach physician issues involving medical necessity when a concern or complaint is brought forward
• Potential auditing for medical necessity issues
• Key considerations in evaluating medical necessity issues, including engagement of a third-party expert
• How to ensure a fair and thorough process
• Recent enforcement action involving medical necessity and the associated risks if not addressed
• Factors to consider and strategy in briefing internal stakeholders of the health system and employer regarding the issues and risk
• Addressing the physician’s employment, role on the medical staff, and educational needs
• Options regarding potential remedial action and mitigation of risk, including voluntary repayments and disclosures
• Differences between employer versus medical staff action

Joe Aguilar, HMS Valuation Partners
Alaina N. Crislip, Jackson Kelly PLLC
Emily Black Grey, Breazeale Sachse & Wilson LLP

With the current instability and shortages in the provider markets, care provided by advanced practice providers (APPs) continues to grow in relative importance. This advanced session will examine the following key aspects of utilizing APPs to provide medical care:

• New models for providing patient care with APPs under complex market conditions
• Compensation models for APPs, fair market value and market volatility
• Billing and revenue intricacies when using APPs (split/shared & incident-to billing)
• Supervision of APPs–varying maze of state supervision requirements, liability considerations, and other challenges

Kristen Kim, VP, Deputy General Counsel, Chief Regulatory Counsel, Memorial Sloan Kettering Cancer Center
Heather H. Pierce, Senior Director for Science Policy and Regulatory Counsel, Association of American Medical Colleges

The international exchange of information and ideas that is critical to advancing scientific research is under increased scrutiny. Academic medical centers and their partners need to respond to warnings from US government officials about the potential national and economic security risks of access to US research information and implement specific requirements to protect the data and the research enterprise. This session will:

• Trace evolving law related to research security policy, including NSPM-33, the CHIPS and Science Act, OSTP guidance for federal agencies to implement research security requirements, proposed BIOSECURE Act, and others
• Describe four essential elements of a research security program under the OSTP Guidelines: 1) cybersecurity, 2) foreign travel security, 3) research security training and 4) export control training
• Provide updates and predictions on Federal agency activities under the new Administration
• Answer practical questions confronted by in-house counsel supporting research activities, including a discussion of balancing open science and data sharing mandates with the need to safeguard research data

Jessica Barth, Senior Health System Counsel, MultiCare Health System
Alissa Smith, Dorsey & Whitney LLP

This session, delivered by in-house health system counsel teamed up with outside counsel, will address the state and federal laws that apply to patient assistance programs. Across the country, hospitals and health systems face increasing challenges with patients who have complex health conditions, including behavioral health, and social determinants of health that make it difficult to effect a safe discharge from the emergency department or the acute setting. At the same time, hospitals and health systems are seeing increasing numbers of patients who frequently return to the emergency department or to acute care because they do not have their chronic health conditions under control. Patient assistance programs can address these problems by, for example, assisting long-stay patients with post-acute services, increase compliance with medical treatment plans through home medical equipment and wearable devices, help get patients to their outpatient appointments through free transportation and other assistance. The presenters will describe the laws that apply and discuss examples of how these laws have been applied to patient assistance programs across the country. The session will also cover one health system’s strategic approach to developing, implementing and operating a variety of patient assistance programs. The session will discuss:

• The federal and state laws that apply to health system patient assistance programs such as free or discounted transportation, post-acute care and other items and services
• The federal and state guidance and enforcement actions related to patient assistance programs
• The legal, financial, and operational challenges facing health systems when developing patient assistance programs
• One health system’s journey toward implementing a comprehensive patient assistance program, involving multi-disciplinary stakeholders from inside and outside the health system
• Sample policies, procedures and agreements that are ancillary to a robust patient assistance program

Vanita Gowda, Chief Communications Officer, Columbia University Irving Medical Center
Rosemary Plorin, CEO, Lovell Communications

• Session description to follow

Anthony J. Burba, Barnes & Thornburg LLP
Ted Lotchin, EVP/Chief Compliance Officer, UNC Health

This panel will discuss the key compliance risks and opportunities facing the health care industry heading into 2025. Panelists will include senior in-house counsel, the Chief Compliance Officer of a large academic and community health system, and experienced outside counsel. The conversational and interactive format will provide different perspectives on key issues facing the industry, including:

• State and federal enforcement priorities for providers and managed care organizations
• DOJ focus on private equity investment in health care
• Continued evolution of self-disclosure priorities
• Benchmarking compliance programs against OIG and DOJ requirements
• Managing risks created by vendors and other third parties

Jacqueline C. Baratian, SVP & Chief Compliance and Privacy Officer, Kaiser Permanente
William (Bill) Mathias, Bass, Berry & Sims
Kenya Woodruff, Katten

The goal of this session is to get the audience involved and to provide practical, real-world discussion of how to diffuse compliance landmines. This is an advanced session that will use hypotheticals to explore ways in which conduct that initially looks problematic may not actually be a problem. We will also use the hypos to discuss the ins and outs of:

• Analyzing situations to identify if there is actually a problem
• Taking corrective action
• If necessary, making a disclosure

The hypos will cover a variety of different compliance issues effecting hospital, physicians, and AMCs, including AKS, Stark, exclusion/licensing, and various billing issues.

Kristin C. Carter, Senior Counsel, Johns Hopkins Health System
Jeff Davis, Bass Berry & Sims

• AMC/hospital lawyers are integral players in a hospital or health system’s 340B program. The session will discuss the role AMC/hospital lawyers can play to support oversight committees and ensure 340B program compliance
• Several drug manufacturers have proposed plans to make 340B pricing available through rebates instead of upfront discounts. The session will discuss the status of litigation related to proposed rebate models and what the impact of rebate models would be on hospitals and health systems
• Government audits of 340B covered entities are continuing to evolve with changing enforcement standards. The session will discuss recent developments and steps AMC/hospital lawyers can take to guide internal discussions related to audit readiness
• In light of recent developments related to litigation on issues of 340B patient eligibility and contract pharmacy use, hospitals and health systems continue to evaluate potential changes to 340B program policies and procedures. The session will consider best practices for how an AMC/hospital lawyer can work with pharmacy staff to evaluate proposed changes

Ritu Kaur Cooper, Hall Render Killian Heath & Lyman
Dwayne Leslie, SVP, General Counsel & Chief Legal Officer, Adventist Healthcare
Teresa A. Williams, Adjunct Professor, University of Oklahoma College of Law

• This presentation will be in a “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
  • Use of social media and generative artificial intelligence
  • Conflicts of interest and much, much more!

Suresh Balu, Director for the Duke Institute for Health Innovation, Associate Dean for Innovation and Partnership for School of Medicine
Hillary N. Kalay, Principal Counsel, ​University of California
Kristen B. Rosati, Coppersmith Brockelman PLC

Artificial Intelligence is ushering in a fundamental shift in how health care is delivered. Good governance plays a critical role in developing, procuring, implementing and auditing any quickly evolving technology, and the stakes for doing it right in health care AI couldn’t be higher. This session will explore the critical issues surrounding governing AI in health care organizations, from legal, clinical and technology perspectives.

• Understanding AI product lifecycle management
• Creating an effective governance structure
• Implementing transparency and consent for patients
• Keeping up with federal and state regulatory requirements

Kirk Nahra, Wilmer Hale
Paul F. Schmeltzer, Clark Hill

• Ransomware continues to be a large risk for the health care sector and its service providers
• Ransomware creates not only massive privacy risk but also ongoing operational concerns
• Companies also face growing enforcement risks related to ransomware attacks
• Identify key concerns, appropriate mitigation strategies and effective techniques for preparing for and addressing ransomware attacks

Delphine O’Rourke, Lead Partner, FemTech Fund III, Portfolia
Rachel Snyder Good, Epstein Becker Green

This session will include an overview of innovation and investment in women's health. The Panelists will discuss the connection between investment and innovation and access to health care, where investment and innovation are taking place, how employers are driving the market for women's health, and investment predictions. The discussion will cover concepts that may include (but are not limited to):

• Current legal and regulatory landscape is impacting innovation and investment in women’s health
• Current tech solutions/investments
• Public-private partnerships between health systems and VC/PE to develop solutions and address challenges
• Ways that hospitals and other providers are implementing solutions

Nicole Demers, Deputy Associate Attorney General, Chief of the Antitrust Section, Office of the Attorney General
Rohan Kochikar Pai, Deputy Assistant Director at Federal Trade Commission, Federal Trade Commission Bureau of Competition
John Saran, Holland & Knight LLP
Christine L. White, Northwell Health

• Health care M&A deals are under increasing scrutiny. A number of states have enacted or are considering new laws related to pre-closing review of health care M&A deals. 2024 was an important year, as California’s new requirements went into effect and Indiana passed a comprehensive law. Meanwhile, five other states failed to pass similar legislation that would augment existing laws
• In addition to heightened state scrutiny of health care deals, federal regulators have increased their scrutiny of health care M&A deals by proposing legislation that would scrutinize private equity investments. The FTC and DOJ have also focused on roll-up strategies and platforms that have significant market concentration. Counsel need to prepare for the impact of the new requirements when considering the timelines for transactions in 2025 as well as the uncertainty created by the additional review and oversight
• Our discussion will guide health care counsel on the recent reporting requirements for parties involved in healthcare M&A deals. The panel will examine the state legislative activity related to scrutiny of health care M&A deals and will discuss how the new laws are changing the playing field. The panel will address the considerations those involved in health care deals need to keep in mind and will offer best practices for navigating the new requirements
• After our presentations, we will engage in a live question and answer session with participants so we can answer your questions about these important issues directly

Michelle Garvey Brennfleck, Buchanan Ingersoll & Rooney PC
Katherine Miler Schilling, Managing Regional Associate General Counsel, University of Michigan

• AMCs are more frequently affiliating with community hospitals and health systems
• Such affiliations may be supported–or even suggested–by state regulators, such as state Attorneys General, that are interested in ensuring that community members have high quality medical care within their communities
• Though potentially financially challenging, affiliating with community hospitals may be desirable for AMCs seeking to shift lower acuity patients to more appropriate community-based settings and to provide varied training environments for residents and students
• AMCs that are state subdivisions may benefit from reduced antitrust scrutiny under the state action doctrine, along with the different competitive position of AMCs and community hospitals (with AMCs historically providing quaternary care and community hospitals historically providing tertiary care)
• In addition to standard transactional and integration considerations, AMCs and community hospitals must carefully consider faculty and medical staff integration, related compensation and regulatory considerations, cultural differences, and how and when to extend the educational and research missions beyond the AMC

Christy Cawthon, Vice President, Medical Economics and Contract Performance, Southwestern Health Resources
Mara McDermott, CEO, Accountable for Health
Brian R. Stimson, Arnall Golden Gregory LLP

• Session description to follow

Marti Arvin, Chief Compliance and Privacy Officer, Erlanger Health
Joseph A. Dickinson, Kaufman & Canoles

This session will discuss the unique compliance and privacy risk that must considered when individuals bring compliance risk to the organization, but they are not under the organization's direct control.

• The intersection of medical staff, medical staff bylaws, and compliance
• Referring providers: How much access do they need and should they have
• Where do community and affiliated providers fit into your compliance program

David J. Peloquin, Ropes & Gray

While the United States has not historically restricted the transfer of personal data outside the country, the past few years have seen the emergence of several limitations on cross-border data flows.  On January 8, 2025, the Department of Justice issued a Final Rule entitled “Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons.”  The Final Rule places limitations on the sharing of several categories of sensitive personal data with the People’s Republic of China (“PRC”) and other countries of concern, as well as covered persons with ties to such countries of concern.  Notably, the Final Rule applies regardless of whether the data in question have been de-identified, pseudonymized or anonymized.  Given its expansive scope, the rule is likely to have major implications for academic medical centers (“AMCs”), health systems and universities that maintain research collaborations or other affiliations with entities located in the PRC and other countries of concern.  In a similar vein, in June 2024, the Protecting Americans’ Data from Foreign Adversaries Act (“PADFAA”) took effect.  PADFAA restricts certain data brokerage activities involving the PRC and other foreign adversary nations.  At the state level, recent years have seen the enactment of legislation that restricts the offshoring of patient data.

This session will provide an overview of these recent legal developments, address implications for AMCs, health systems, and universities, and offer practical strategies for coming into compliance.

Meri Gordon, Polsinelli
Courtney Grande, Senior Corporate Counsel-Managed Care,Community Health Systems (CHSPSC, LLC)

• Session description to follow

Ritu Kaur Cooper, Hall Render Killian Heath & Lyman
Dwayne Leslie, Adventist Healthcare
Teresa A. Williams, University of Oklahoma College of Law

• This presentation will be in a “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
  • Use of social media and generative artificial intelligence
  • Conflicts of interest and much, much more!

Jerry Chang, BRG
Brynne Goncher, Vice President, Deputy General Counsel at Piedmont Healthcare
Thomas H. Hawk, King & Spalding

• Why JV? Market trends driving consideration of this model
• Examples of JV models and “JV – lite” models
• Key governance considerations in hospital / physician joint ventures
• Special considerations when hospital partner is an academic medical center
• What are we seeing?  Service lines frequently involved in JVs
• Regulatory considerations
• Importance of FMV support for various aspects of the arrangement
• Unique valuation considerations for JVs

Daniel Cody, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, PC
Jonathan A. Porter, Husch Blackwell LLP

• Statistical analysis of trends in civil False Claims Act litigation and other health care industry enforcement litigation
• Health care fraud enforcement priority areas including anti-kickback statute, Stark Law, managed care, COVID-19 relief funds, and private equity
• Overview of federal and state agency guidance and policy developments including benefits of self-disclosures and whistleblower pilot programs
• Collaboration across federal agencies in health care enforcement

Joe Aguilar, HMS Valuation Partners
Alaina N. Crislip, Jackson Kelly PLLC
Emily Black Grey, Breazeale Sachse & Wilson LLP

With the current instability and shortages in the provider markets, care provided by advanced practice providers (APPs) continues to grow in relative importance. This advanced session will examine the following key aspects of utilizing APPs to provide medical care:

• New models for providing patient care with APPs under complex market conditions
• Compensation models for APPs, fair market value and market volatility
• Billing and revenue intricacies when using APPs (split/shared & incident-to billing)
• Supervision of APPs–varying maze of state supervision requirements, liability considerations, and other challenges

Suresh Balu, Director for the Duke Institute for Health Innovation, Associate Dean for Innovation and Partnership for School of Medicine
Hillary N. Kalay, Principal Counsel, ​University of California
Kristen B. Rosati, Coppersmith Brockelman PLC

Artificial Intelligence is ushering in a fundamental shift in how health care is delivered. Good governance plays a critical role in developing, procuring, implementing and auditing any quickly evolving technology, and the stakes for doing it right in health care AI couldn’t be higher. This session will explore the critical issues surrounding governing AI in health care organizations, from legal, clinical and technology perspectives.

• Understanding AI product lifecycle management
• Creating an effective governance structure
• Implementing transparency and consent for patients
• Keeping up with federal and state regulatory requirements