Schedule

Asha Scielzo, AHLA President
David S. Cade, AHLA Executive Vice President/Chief Executive Office

Michael J. Dowling, CEO Northwell Health

• Session description to follow

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

Offering more substance than the nightly news, our panel will cover key developments over the past year and identify industry and enforcement trends. Highlights include:

• The Trump Administration’s new players
• The impact of the Executive Orders
• Actual and proposed Federal spending cuts
• False Claims Act case law and settlements (key cases and enforcement trends)
• Stark and Anti-kickback developments
• Health Care Transactions (from hot trends, to record number of bankruptcies, to private equity, to tax issues, to new antitrust theories)
• HIT developments (cyber-attacks, information blocking and interoperability, OCR enforcement, and new state laws)
• AI in Health Care
• No Suprises Act enforcement
• Reimbursement trends and 340B
• And Much MORE!

Heather Alleva, Associate General Counsel, Main Street Health
Michael F. Schaff, Wilentz Goldman & Spitzer PC
Alexander D. Sharnoff, Principal Counsel, Thomas Jefferson University

• Pre-Transaction Considerations
• Non-Disclosure/Confidentiality/Evaluation Material Agreements
• Letter of Intent/Term Sheet
• Choosing the Appropriate Acquisition Model
• Valuation and FMV
• Due Diligence
• Typical Contract Provisions
• Hidden Risks of Boilerplate Provisions
• Controlling the Process and Managing Expectations
• Post-Closing Transaction Issues

Bryan Perry, FTI Consulting
Elizabeth Odette, Assistant Attorney General at Office of the Minnesota Attorney General and Antitrust Task Force Chair, National Association of Attorneys General
Amanda Wait, DLA Piper

Federal and state antitrust enforcers have continued their focus on vigorous antitrust enforcement in health care mergers and other transactions. Review of recent transactions and published statistics of merger reviews, however, suggests that health care transactions can survive antitrust review. This panel will address:

• Anticipating substantive antitrust scrutiny and understanding the enforcement perspective, including enforcement theories under the 2023 Merger Guidelines
• Anticipating and planning for the antitrust review process, including appropriate time frames for review, operational burdens and similar practical concerns 
• Managing joint or simultaneous federal and state antitrust review as well as reviews pursuant to state charities and/or healthcare notification laws

Cora Han, Chief Health Data Officer for University of California Health (UCH) and Executive Director of the Center for Data-driven Insights and Innovation (CDI2), UCH
Lucia Savage, Chief Privacy & Regulatory Officer, Omada Health, Inc.
Alya Sulaiman, Chief Compliance and Privacy Officer, Datavant, Inc. Los Angeles, CA

• This dynamic session brings together leaders from three distinct organizations across the health care ecosystem who have successfully guided and implemented AI governance frameworks to share lessons learned and actionable insights
• Each panelist has contributed to developing and implementing AI governance processes for their organizations, although the three organizations where the panelists work are very different from one another and may approach health AI through different lenses. Through the panelists' diverse experiences, attendees will gain practical insights (informed by lived experience) into establishing effective oversight for AI solutions developed, procured, and/or implemented across different health care contexts
• By comparing and contrasting the three organizations’ AI Governance frameworks, processes, and requirements, attendees will obtain a broad view of what has been workable, at a practical level, in this new area of emerging legal and compliance risk and accountability

Anthony J. Burba, Barnes & Thornburg
Jason Ehrlinspiel, Chief Compliance Officer, Ardent Health
Leah Voigt, Chief Compliance Officer, Corewell Health

• Session description to follow

Karen Kole, ECG
Leah D'Aurora Richardson, Foley & Lardner

• Session description to follow

Daniel J. Hettich, King & Spalding

• Session description to follow

Penka Kovacheva, Vice President, Cornerstone Research
Rob McNary, Latham & Watkins
Leslie Overton, Axinn Veltrop & Harkrider

Agency investigations and the latest merger guidelines portend increased antitrust scrutiny of companies operating in the healthcare and life sciences industries. This panel discusses legal and economic aspects of less explored antitrust theories, such as alleged harm from serial acquisitions, reduced innovation, rebate bundling, patent listings, algorithmic collusion, and steering to integrated pharmacy and physician networks.

Dasheeda Dawson, Cannabis Regulators of Color Coalition (CRCC)
Matt Donze, Chief Counsel, Evernorth Health Services
Jason Mayer, Reed Smith

Despite a challenging history and legal landscape, cannabis and psychedelics have emerged as potentially legitimate treatment options in the United States. Over the past year, the DEA proposed a rule to re-schedule cannabis as a Schedule III drug under the Controlled Substances Act, which would recognize its potential for currently accepted medical uses in treatment and provide a pathway for eventual FDA approval. At least one state has also introduced legislation to mandate insurance coverage for medical cannabis. Congress recently authorized research grants to study the effectiveness of psychedelics in treating armed servicemembers. The FDA has just reviewed – and is expected to continue reviewing – requests for approval to use MDMA for PTSD treatment. And ketamine clinics are increasingly prevalent throughout the country as a means for treating severe depression and other mental health conditions.

The country’s changing approach to these drugs happened through three very different approaches for reform: state led initiatives, innovation in the private sector, and direct appeals to the FDA. In this presentation, we plan to discuss the history and current legal landscape for these emerging therapies, the varying approaches to reform that led to their emergence in the U.S. as legitimate treatment options, and health care coverage and litigation implications and considerations, including current litigation over coverage for medical cannabis.

Greg Endicott, President and CEO, ValueVision, inc. and Managing Director at Strategic Value Group, LLC
Eric Leafgreen, VP of Provider Compensation, Ludi, Inc.
David Schoolcraft, Ogden Murphy Wallace

As AI technology transforms industries, its impact is quickly extending deeply into the health care workforce, reshaping roles and processes across the entire provider landscape. This transformation brings unique challenges and opportunities, particularly for health care lawyers who advise on compliance, workforce integration, and compensation structures. This session will dive into how AI is changing the provider enterprise as we know it today, enhancing operational efficiency, and mitigating regulatory risks across diverse provider roles, including physicians, advanced practice practitioners (APPs), and specialists.

• Background of AI
• AI use cases in health care
• AI’s impact on the provider workforce, including how it's reshaping provider compensation
• Operational efficiency and support hospital and health system workforce growth through AI-driven resources
• Legal and compliance landscape for seamless AI integration in health care settings
• AI Governance

Nicholas Alarif, McDermott Will & Emery LLP
Albert W. Shay, Morgan, Lewis & Bockius LLP

The presenter will utilize hypos to address the complexities of assessing Physician Self-Referral Law compliance in the context of physician practice acquisitions, including:

• A brief overview of the requirements of the Physician Self-Referral Law’s In-Office Ancillary Services Exception and definition of Group Practice
• How should a buyer assess Physician Self-Referral Law compliance in the context of a proposed transaction and is there anything the seller can do in anticipation of due diligence on these issues?
• Common (and some potentially missed) issues compliance issues that often arise during diligence
• Options for addressing instances of non-compliance identified in the due diligence process – i.e., to disclose or not to disclose, including the perspective of purchaser’s counsel and seller’s counsel
• Complexities associated with addressing non-compliance in the purchase agreement, including which party has “control” over the disclosure, escrow versus holdback, what happens if additional Physician Self-Referral Prohibition issues are identified post-closing

Kelly Pollock, Vice President and Assistant General Counsel, Novant Health
Maria Salgado, Vice President, Cornerstone Research
Shalyn Watkins, Holland & Knight

• New laws and regulations related to data privacy and health information privacy which impact providers daily.
• Recent legal changes in the vendor privacy and cybersecurity space
• Learnings from recent high profile health care vendors who have experienced large data breaches
• The intricacies of new vendor technologies and approaches and their impact on providers; including the most recent litigation and enforcement actions in the space
• The economic factors and impact of data breaches and poorly managed vendor relationships on providers
• Practical strategies to diligence future vendors and ensure contracts are developed that protect your organization
• Utilize hypotheticals to engage audience in identifying all risk areas when engaging with new vendors including artificial intelligence vendors

Annie Shieh, AVP Compliance, Molina Healthcare
Judith A. Waltz, Foley & Lardner

• Whose job is MA compliance anyway? Differing expectations for plans and providers
• What’s new for plans?
• Operational impacts for providers including applicability of FFS guidelines, promoting social determinants of health, and living with prior authorizations
• The impact of new government guidance: the OIG Compliance Guidance for Managed Care (expected); the 60-day Refund Rule (as revised effective Jan. 1, 2025)
• The changing environment for enforcement actions against plans and providers
• Practical tips for aligning compliance programs with the new expectations

Ted Lotchin, System Chief Compliance Officer, UNC Health, Office of the CEO and Dean
William T. Mathias, Bass Berry & Sims

• Session description to follow

Gina L. Bertolini, K&L Gates
Joanne (Jody) Joiner, Senior Counsel, Tenet Healthcare

• The practical and legal ways the first four months of Donald Trump’s Presidency have impacted women’s reproductive rights, including:
  • Changes in state or federal statutes or regulations affecting reproductive health, including changes in interpretation
  • Impact of possible changes to Medicaid
  • Updates on state and federal privacy laws (e.g., HIPAA) related to reproductive health
  • Efforts to restrict access to birth control (e.g., Plan B) and the “abortion pill” (mifepristone)
  • Updates on EMTALA, including the interplay with state abortion laws
  • Enforcement of state reproductive health laws across state lines
• Throughout the above discussion, we will raise hypothetical scenarios showing how the Rules of Professional Responsibility impact the attorney’s role as an advisor

Jennifer Csik Hutchens, Dechert LLP
Thomas Spellman, Associate General Counsel, Vice President; Fresenius Medical Care

• The different types of joint ventures
• Pros and cons of using a joint venture compared to other M&A transaction types
• A framework for analyzing potential legal and regulatory challenges facing joint ventures
• The financial matters facing a joint venture, including funding, capital contributions, JV accounting, and distributions
• Other major decision points facing joint ventures, including decision-making, entrance and exit rights, member covenants, growth and new business opportunities, and dissolution
• Apply these strategies to a case study (physician-private equity transaction) to understand how various factual scenarios could affect the transaction and to highlight diligence and transactional considerations

Jim Carr, InHealth Advisors
Rachel Polzin, Senior Counsel, SSM Health
Scott Strickland, Hall Render Killian Heath & Lyman PC

• A brief introduction of the value-based enterprise (VBE) framework
• Several common issues impacting health care providers that can be addressed using value-based arrangements
• How various stakeholders and objectives align in value-based models to address these challenges
• The pros and cons of adopting such VBE strategies, including legal and operational implications for organizations
• Translate these example scenarios into actionable strategies for provider organizations

Marc D. Goldstone, Chief Legal Officer, Wellpath
Eric Zimmerman, McDermott +

This session will address the rapidly evolving world of Governmental scrutiny and regulation of Private Equity investment in the healthcare sector, including:

• Review of Current regulatory notice and/or approval schemes
• The impact on in-flight/recently closed transactions
• Proposed statutes/regs under consideration
• Trajectory of State/Federal governance interest
• Non-traditional PE investment strategies (i.e., non-profit JVs, etc.) which may or may not be implicated by such regulatory authority.
• Strategies to take existing and potential regulatory scrutiny into account when structuring future transactions

Christopher Finch, Vice President, Chief Compliance and Audit Officer, MemorialCare, Long Beach, CA
Adam Greene, Davis Wright Tremaine LLP

• The status of HIPAA amendments to the Privacy Rule to protect reproductive health privacy and proposed changes to the HIPAA Security Rule under the new administration
• Continuing regulatory and litigation risks related to health care websites and disclosures of user information to third parties
• Whether recent changes to the Confidentiality of Substance Use Disorder Patient Records at 42 C.F.R. part 2 create decreased or increased legal risks to health care organizations
• The federal push for interoperability and health information exchange and corresponding legal risks from breaches

Larry Gage, Alston & Bird LLP
Aaron Rabinowitz, Senior Vice President and General Counsel, University of Maryland Medical System

We will be presenting on current trends and best governance practices of high-performing nonprofit multi-hospital systems, based on a survey conducted in 2023-2024 of 17 such systems. The session will focus on several specific topics, including:

• Recent trends in the size, composition, selection, and tenure of hospital system governing boards
• The governance challenges faced by systems that have formed through mergers or acquisitions requiring the integration of governing boards and legal structures that may differ widely from one another
• The governance of subsidiary hospitals, including the pros and cons of consolidating fiduciary authority at the level of the system board and limiting the authority, accountability, and decision-making responsibility of subsidiaries
• The challenges faced by faith-based systems, including governance approaches adopted in mergers between faith-based and secular hospitals
• The unique governance challenges of systems centered around major teaching hospitals that are wholly owned by universities as well as those that have been spun off by universities into independent nonprofit corporations, with a case study of the recent governance journey of one state university hospital system with a quasi-independent nonprofit structure

Henry Leventis, Holland & Knight
Justin Pitt, General Counsel, Community Health Systems

• Where and how AI is being used in the delivery of healthcare and billing (with a focus on hospital systems)
• How AI is being used, or will be used in the future, in compliance and enterprise risk management
• How the regulatory community, including the Justice Department and state AG’s offices are viewing these trends
• How regulators are currently AI in their investigations, including in their review and analysis of claims data, and how AI might impact investigations moving forward

Lona Fowdur, Founding Partner, Econic Partners
Alexis Gilman, Crowell  & Moring LLP
Mitch Glende, Senior Counsel, Intermountain Health

Common activities of hospitals and health systems can raise antitrust issues more frequently than some might realize. This introductory-level presentation will help in-house counsel identify common antitrust issues and provide practical guidance to mitigate risk. The session will cover the following hot topics:

• Dos and Don’ts for meetings and collaborations with competitors, information sharing, and benchmarking
• Potential concerns arising from managed care contracting, including the use of anti-tiering, anti-steering, or all-or-nothing clauses
• Potential risks areas in the human resources context, including wage fixing, no-poach agreements, and noncompete and non-solicitation clauses
• Issue spotting for mergers and acquisitions, joint ventures, and other affiliations
• When to add an economist to your risk review team

Tynan Kugler, PYA, PC
Mara Smith-Kouba, Counsel, Regulatory Law, Bristol Myers Squibb

Medical device, pharmaceutical, laboratory, and biotech arrangements continue to garner the attention of regulators and failure to compliantly engage with physicians, advanced practice providers, and other professionals can bring False Claims Act actions against life sciences companies. As a result, organizations should consistently evaluate the reasons for, and risks associated with developing and implementing programs that provide value to referral sources and structure such arrangements to avoid improper interactions. This presentation will discuss:

• Current key regulatory and compliance considerations associated with various recent settlements and describe the implications in practice
• Best practices regarding development, implementation, and maintenance of common referral source arrangements such as key opinion leader engagement, marketing services arrangements, physician-owned distributorships, among others
• Critical components to mitigate undue influence
• In-house and external perspectives on establishing and operationalizing relationships in a compliant manner

Annie Shieh, AVP Compliance, Molina Healthcare
Judith A. Waltz, Foley & Lardner

• Whose job is MA compliance anyway? Differing expectations for plans and providers
• What’s new for plans?
• Operational impacts for providers including applicability of FFS guidelines, promoting social determinants of health, and living with prior authorizations
• The impact of new government guidance: the OIG Compliance Guidance for Managed Care (expected); the 60-day Refund Rule (as revised effective Jan. 1, 2025)
• The changing environment for enforcement actions against plans and providers
• Practical tips for aligning compliance programs with the new expectations

Jim Carr, InHealth Advisors
Rachel Polzin, Senior Counsel, SSM Health
Scott Strickland, Hall Render Killian Heath & Lyman PC

• A brief introduction of the value-based enterprise (VBE) framework
• Several common issues impacting health care providers that can be addressed using value-based arrangements
• How various stakeholders and objectives align in value-based models to address these challenges
• The pros and cons of adopting such VBE strategies, including legal and operational implications for organizations
• Translate these example scenarios into actionable strategies for provider organizations

Diana Kruze, Arbitrator
Christopher C. Sabis, Sherrard Roe

• Whether and how to use alternative dispute resolution ("ADR") in health care disputes
• Pros and cons of selecting arbitration over litigation, with focus on the often-unique context of health care disputes
• Recommendations and sample dispute resolution clauses to achieve certain purposes
• How careful drafting can artfully craft the desired arbitration process
• Discussion of some health care areas where ADR has worked well and where it is ripe for expansion

Adrienne Frazior, Polsinelli
Jody Rudman, Husch Blackwell

• The COVID-19 pandemic significantly accelerated the adoption of telehealth services, leading to temporary regulatory relaxations. Now, in the post-pandemic regulatory environment, measures are being revised and solidified into more permanent frameworks.
• Behavioral health services have seen a particular emphasis on integrating telehealth to address increased mental health needs that have emerged.
• Key areas of enforcement now include securing patient data, standardizing telehealth practices, and addressing disparities in access to care.
• Presenters will discuss how robust cybersecurity measures and strict adherence to privacy laws have become focal points to safeguard sensitive health data.
• Compliance with both state and federal laws, including adherence to licensure requirements, ensuring proper documentation, and meeting reimbursement criteria have become particularly important for providers in this space and those who counsel them.
• Real-life examples will be used to illustrate enforcement trends

Timothy A. Hilton, Husch Blackwell LLP
Gary McLaughlin, Mitchell Silberberg & Knupp LLP

• Session description to follow

Caroline Burgunder, Assistant United States Attorney, Chief, Affirmative Litigation Unit, US Attorney’s Office, Eastern District of Michigan
Brandon Helms, Hall Render Killian Heath & Lyman PC

This presentation would cover what to expect during an FCA investigation from start to finish.

• How an FCA investigation starts--either based on a whistleblower qui tam, data analysis, or non-qui-tam tip.
• How to respond to a Civil Investigative Demand and what to expect
• Settlement Negotiations
• Government intervention or declination
• FCA Litigation

Cora Han, Chief Health Data Officer for University of California Health (UCH) and Executive Director of the Center for Data-driven Insights and Innovation (CDI2), UCH
Lucia Savage, Chief Privacy & Regulatory Officer, Omada Health, Inc.
Alya Sulaiman, Chief Compliance and Privacy Officer, Datavant, Inc. Los Angeles, CA

• This dynamic session brings together leaders from three distinct organizations across the health care ecosystem who have successfully guided and implemented AI governance frameworks to share lessons learned and actionable insights
• Each panelist has contributed to developing and implementing AI governance processes for their organizations, although the three organizations where the panelists work are very different from one another and may approach health AI through different lenses. Through the panelists' diverse experiences, attendees will gain practical insights (informed by lived experience) into establishing effective oversight for AI solutions developed, procured, and/or implemented across different health care contexts
• By comparing and contrasting the three organizations’ AI Governance frameworks, processes, and requirements, attendees will obtain a broad view of what has been workable, at a practical level, in this new area of emerging legal and compliance risk and accountability

Karen Kole, ECG
Leah D'Aurora Richardson, Foley & Lardner

• Session description to follow

Curtis Bernstein, Pinnacle Healthcare Consulting
Claire Topp, Dorsey & Whitney LLP

• Session description to follow

Gerald M. Griffith, Jones Day

• Session description to follow

Michaela Poizner, Baker Donelson
Katie Tarr, LBMC

A lively, humorous approach to the sticky situation facing many internal and external counselors: Clients who insist that they cannot recruit providers to staff their facilities at fair market value rates. This session will, with straight-talk and irreverence, cover:

• Trends in provider compensation models: The tried and true, the new flavors, and the “so last season”
• What flexibility do systems, facilities and practices have, really, when it comes to fair market value and commercial reasonableness?
• Creative ways to increase compensation, while staying on the right side of the law
• “Is this really an emergency?” or, how to effectively work with high-pressure operators
• Practical tips for leveling up your provider compensation function: From hiring need to start date (and beyond)

Manasa Gopal, Legal Counsel, Columbia University Medical Center
Robert S. Paskowski, PYA PC
Salvatore G. Rotella, Buchanan Ingersoll & Rooney PC

• Why good rates are often not enough (e.g. recoupments, downgrading, payment policies, site of service, etc.)
• Value based payment components to network participation - What's new and how to tackle what's old and no longer working
• Challenging the adequacy of payor networks and why such challenge matters when negotiating with payers
• Direct messaging to purchasers (member and employers) - enlisting assistance from patients and health plan sponsors while steering clear of tortious interference
• Negotiating strategies and tactics

Anthony J. Burba, Barnes & Thornburg
Jason Ehrlinspiel, Chief Compliance Officer, Ardent Health
Leah Voigt, Chief Compliance Officer, Corewell Health

• Session description to follow

Jennifer Csik Hutchens, Dechert LLP
Thomas Spellman, Associate General Counsel, Vice President; Fresenius Medical Care

• The different types of joint ventures
• Pros and cons of using a joint venture compared to other M&A transaction types
• A framework for analyzing potential legal and regulatory challenges facing joint ventures
• The financial matters facing a joint venture, including funding, capital contributions, JV accounting, and distributions
• Other major decision points facing joint ventures, including decision-making, entrance and exit rights, member covenants, growth and new business opportunities, and dissolution
• Apply these strategies to a case study (physician-private equity transaction) to understand how various factual scenarios could affect the transaction and to highlight diligence and transactional considerations

Kimberly Daniel, Hancock Daniel & Johnson, PC
Rachel Freyman, Senior Litigation and Regulatory Counsel, MultiCare Health System

This presentation addresses the complexities of managing physician behavior and quality of care issues within health care organizations, particularly from the medical staff and employment perspectives. We will explore:

• Practical strategies for addressing physician behavior and quality of care concerns
• How health care organizations can navigate challenges in both independent and employed physician models
• The role of legal, human resources, medical staff, peer review, quality, and compliance processes in managing sensitive physician-related challenges
• Balancing legal obligations, patient safety, and organizational culture in disciplinary and remediation efforts

Suzanne Koenig, SAK Management
Janus Pan, Greenberg Traurig LLP

• Increasing trend of private equity and private ownership acquisition of long-term care facilities, such as nursing homes and assisted living facilities
• Private ownership of LTC facilities oftentimes results in similar or better standards of care than nonprofit ownership
• Private owners and private equity firms entering the LTC space should watch out for regulatory scrutiny, risk of government investigations, and enforcement of standards of care such as nurse staffing ratios
• Presentation speakers will include a law firm attorney and a consultant from a health care management and consulting services firm

Stephen Lee, Stephen Lee Law
Felicia Y. Sze, Athene Law LLP

• Legal practice is messy, but sometimes we come across intentional and unintentional ethical lapses
• How do we as lawyers respond to ethical issues, like mailing the other side’s clients ex parte or improper ex parte communications with judges
• How do we ensure that we continue to meet the standards for our profession to ensure that we remain fluent in new technologies/data tools and how to ensure proper technical support for complex cases
• How to navigate when clients are getting conflicting advice from other sources (or are shopping for the advice they want)
• How internal documentation can both protect attorneys and clients

Jeffrey I. Davis, Bass Berry & Sims PLC
Michelle Rae Pinzon, Senior Associate General Counsel, Northwell Health

Hospitals and other “Covered Entities” benefit from discounted drug prices under the 340B Drug Pricing Program, which allows them to stretch scarce federal resources, reach more eligible patients, and provide more services for underserved populations. Recently, drug manufacturers have mounted a variety of challenges to the 340B Program, leading to uncertainty, the issuance by HRSA of new interpretations of applicable obligations, and numerous lawsuits that could change the 340B Program as we know it–and dramatically impact the finances of many Covered Entities. The session, which is intended for an intermediate/advanced audience with familiarity with the 340B Program, will cover the following hot topics:

• Ongoing Agency enforcement actions against 340B providers and/or manufacturers
• Current Litigation Landscape of the 340B Program
• Different Stakeholders’ Positions on 340B
• Proposed legislation related to 340B

Nicholas Alarif, McDermott Will & Emery LLP
Albert W. Shay, Morgan, Lewis & Bockius LLP

The presenter will utilize hypos to address the complexities of assessing Physician Self-Referral Law compliance in the context of physician practice acquisitions, including:

• A brief overview of the requirements of the Physician Self-Referral Law’s In-Office Ancillary Services Exception and definition of Group Practice
• How should a buyer assess Physician Self-Referral Law compliance in the context of a proposed transaction and is there anything the seller can do in anticipation of due diligence on these issues?
• Common (and some potentially missed) issues compliance issues that often arise during diligence
• Options for addressing instances of non-compliance identified in the due diligence process – i.e., to disclose or not to disclose, including the perspective of purchaser’s counsel and seller’s counsel
• Complexities associated with addressing non-compliance in the purchase agreement, including which party has “control” over the disclosure, escrow versus holdback, what happens if additional Physician Self-Referral Prohibition issues are identified post-closing

Kelly Pollock, Vice President and Assistant General Counsel, Novant Health
Maria Salgado, Vice President, Cornerstone Research
Shalyn Watkins, Holland & Knight

• New laws and regulations related to data privacy and health information privacy which impact providers daily.
• Recent legal changes in the vendor privacy and cybersecurity space
• Learnings from recent high profile health care vendors who have experienced large data breaches
• The intricacies of new vendor technologies and approaches and their impact on providers; including the most recent litigation and enforcement actions in the space
• The economic factors and impact of data breaches and poorly managed vendor relationships on providers
• Practical strategies to diligence future vendors and ensure contracts are developed that protect your organization
• Utilize hypotheticals to engage audience in identifying all risk areas when engaging with new vendors including artificial intelligence vendors

H. Holden Brooks, McGuire Woods
Vic Domen, DLA Piper
Terry Williams, Vice Chief Academic Officer–Transformative Solutions, Atrium Health, Wake Forest University, School of Medicine

• Hospital closure is often economically and politically unpalatable, even when a hospital experiences financial distress
• What’s a flailing system (or other provider entity) to do? Merge? Private Equity? COPA?  Hope the environment changes?
• Antitrust evaluation of post-pandemic business model realities for academic medical centers and community/rural hospitals may require new perspectives but what will the Enforcers think of these novel proposals and solutions?

R. Ross Burris, Polsinelli
Lindsey L. Lonergan, Wellspan

• Operational concerns and solutions to consider if under an audit for Medicare, Medicaid or a commercial payor
• Specific concerns and solutions for post-acute providers including hospice, home health, DME, etc.
• 3Strategies for handling different audits, e.g., a UPIC audit resulting in a payment suspension, a multi-level TPE audit or commercial pre-pay audits
• 4Discussions of tactics outside of the appeal or ADR process, e.g., negotiation of payment plans, seeking intervention of government officials

Anna Whites, Anna Whites Law Office
Matt Wolfe, Baker Donelson

• Physical health providers, health systems and hospitals often struggle with how to handle behavioral health issues as they arise. Many facilities don't have staff trained to link those patients with existing services or local providers who can address those issues. This session will discuss simple and effective strategies to prepare providers for managing or effectively referring behavioral health patients
• The old fashioned division of health care into "physical" and "mental" health has become outdated. Today's practitioners need to learn to address the entire patient in a wholistic and coordinated manner. Building a  health care system that can cover all the care a patient needs is both simple and cost effective. Learn what providers need to know in order to facilitate care of the whole person
• Reimbursement for behavioral health care, particularly in the addiction space, can be challenging for novice providers. The session will include discussion of relevant billing concerns and best practices for effective coding of care

Andrew Reitz, Vice President, Compliance, Buckeye Health Plan (subsidiary of Centene Corporation)
Debra Rossi, VMG Health

• AI in Compliance Audits
• Consultant vs. Payer Perspectives
• Proactive Compliance Strategies
• Defensive Audit Strategies
• AI’s Impact on Provider Scrutiny
• Best Practices for AI in Compliance

Daniel J. Hettich, King & Spalding

• Session description to follow

Marc D. Goldstone, Chief Legal Officer, Wellpath
Eric Zimmerman, McDermott +

This session will address the rapidly evolving world of Governmental scrutiny and regulation of Private Equity investment in the healthcare sector, including:

• Review of Current regulatory notice and/or approval schemes
• The impact on in-flight/recently closed transactions
• Proposed statutes/regs under consideration
• Trajectory of State/Federal governance interest
• Non-traditional PE investment strategies (i.e., non-profit JVs, etc.) which may or may not be implicated by such regulatory authority.
• Strategies to take existing and potential regulatory scrutiny into account when structuring future transactions

Priya Bathija, Founder + CEO, Nyoo Health
Ashley Keith, Assistant Professor of Law, The University of Akron Law School
April E. Schweitzer, General Counsel, Gateway Foundation

• A framework for health, health equity, and health justice; the role of social and structural drivers of health
• Current initiatives to advance health equity
• The impact of law and policy on health equity
• Collaboration and the roles of physicians and other health care professionals, hospitals/ health systems, and payors
• Concrete action steps for the legal community

Robyn Diaz, Senior Vice President and Chief Legal Officer for St. Jude Children’s Research Hospital
John E. Kelly, Barnes & Thornburg LLP
Sarah Swank, General Counsel, On Belay Health Solutions

The legal profession can be rewarding, and yet it isn't known for being easy. It is also part of our lives and lives just like sandwiches can come in many different varieties and flavors. For some of us, we can be squeezed between two slices of bread with outside responsibilities such as caring for kids and aging parents, and others face pressures of high expectations of ourselves or others outside of work. In this session, the panel will discuss identifying trauma in yourself and others, the employment law you to know, your ethical obligations and how we set ourselves up for balance. And we promise no yoga in our suits!

• What are some of the outside pressures we face and is it okay to talk about them?
• What are the numbers of law professional suffering and what causes these issues?
• And what does wellness and balance mean anyway? (and the answer is not eating another sandwich - unless it is from NYC!)
• How best to manage stress and burnout, and in some cases secondary trauma?
• How to spot if you or a colleague are in a pickle or actually facing a crisis? How do you balance expectations at work when that happens?
• What are the employment laws you need to know? What are your ethical obligations?

Stephen R. Kleinman, Epstein Becker & Green PC
Shelli E. Stoker, Vice President and Assistant General Counsel, Novant Health Legal Department

• Understanding State Law Variability–Overview of examples of state-specific peer review protections, privileges, and reporting requirements that impact multi-state health care organizations
• Legal and Compliance Challenges–How differing state laws may affect information sharing, confidentiality, and risk exposure in peer review processes
• Strategic Approaches to Compliance–Options for structuring peer review and when to apply state law vs. federal protections (PSQIA)
• Practical Considerations and Case Studies–Hypotheticals that discuss pros and cons of sharing information
• Waivers and Risk Management–When, why, and how organizations may consider waiving peer review protections and the legal risks involved
• Balancing Factors in Decision-Making–Key considerations for legal, operational, and patient safety goals when structuring multi-state peer review processes

Greg Endicott, President and CEO, ValueVision, inc. and Managing Director at Strategic Value Group, LLC
Eric Leafgreen, VP of Provider Compensation, Ludi, Inc.
David Schoolcraft, Ogden Murphy Wallace

As AI technology transforms industries, its impact is quickly extending deeply into the health care workforce, reshaping roles and processes across the entire provider landscape. This transformation brings unique challenges and opportunities, particularly for health care lawyers who advise on compliance, workforce integration, and compensation structures. This session will dive into how AI is changing the provider enterprise as we know it today, enhancing operational efficiency, and mitigating regulatory risks across diverse provider roles, including physicians, advanced practice practitioners (APPs), and specialists.

• Background of AI
• AI use cases in health care
• AI’s impact on the provider workforce, including how it's reshaping provider compensation
• Operational efficiency and support hospital and health system workforce growth through AI-driven resources
• Legal and compliance landscape for seamless AI integration in health care settings
• AI Governance

Caroline Burgunder, Assistant United States Attorney, Chief, Affirmative Litigation Unit, US Attorney’s Office, Eastern District of Michigan
Brandon Helms, Hall Render Killian Heath & Lyman PC

This presentation would cover what to expect during an FCA investigation from start to finish.

• How an FCA investigation starts--either based on a whistleblower qui tam, data analysis, or non-qui-tam tip.
• How to respond to a Civil Investigative Demand and what to expect
• Settlement Negotiations
• Government intervention or declination
• FCA Litigation

Manasa Gopal, Legal Counsel, Columbia University Medical Center
Robert S. Paskowski, PYA PC
Salvatore G. Rotella, Buchanan Ingersoll & Rooney PC

• Why good rates are often not enough (e.g. recoupments, downgrading, payment policies, site of service, etc.)
• Value based payment components to network participation - What's new and how to tackle what's old and no longer working
• Challenging the adequacy of payor networks and why such challenge matters when negotiating with payers
• Direct messaging to purchasers (member and employers) - enlisting assistance from patients and health plan sponsors while steering clear of tortious interference
• Negotiating strategies and tactics

• Session description to follow

Dr. Michael Conroy, President and CEO, Sutter Medical Group
Florence L. Di Benedetto, Strategic Leader, Executive Coach, Business and Legal Consultant, General Counsel, Di Benedetto Solutions, Inc.
Dr. Mohit Kaushal, Senior Advisor, General Atlantic
Richard Roth, Chief Strategic Innovation Officer and President, Common Spirit Ventures

• Session description to follow

Christopher Finch, Vice President, Chief Compliance and Audit Officer, MemorialCare, Long Beach, CA
Adam Greene, Davis Wright Tremaine LLP

• The status of HIPAA amendments to the Privacy Rule to protect reproductive health privacy and proposed changes to the HIPAA Security Rule under the new administration
• Continuing regulatory and litigation risks related to health care websites and disclosures of user information to third parties
• Whether recent changes to the Confidentiality of Substance Use Disorder Patient Records at 42 C.F.R. part 2 create decreased or increased legal risks to health care organizations
• The federal push for interoperability and health information exchange and corresponding legal risks from breaches

Michaela Poizner, Baker Donelson
Katie Tarr, LBMC

A lively, humorous approach to the sticky situation facing many internal and external counselors: Clients who insist that they cannot recruit providers to staff their facilities at fair market value rates. This session will, with straight-talk and irreverence, cover:

• Trends in provider compensation models: The tried and true, the new flavors, and the “so last season”
• What flexibility do systems, facilities and practices have, really, when it comes to fair market value and commercial reasonableness?
• Creative ways to increase compensation, while staying on the right side of the law
• “Is this really an emergency?” or, how to effectively work with high-pressure operators
• Practical tips for leveling up your provider compensation function: From hiring need to start date (and beyond)

Stephen Lee, Stephen Lee Law
Felicia Y. Sze, Athene Law LLP

• Legal practice is messy, but sometimes we come across intentional and unintentional ethical lapses
• How do we as lawyers respond to ethical issues, like mailing the other side’s clients ex parte or improper ex parte communications with judges
• How do we ensure that we continue to meet the standards for our profession to ensure that we remain fluent in new technologies/data tools and how to ensure proper technical support for complex cases
• How to navigate when clients are getting conflicting advice from other sources (or are shopping for the advice they want)
• How internal documentation can both protect attorneys and clients

Stephen R. Kleinman, Epstein Becker & Green PC
Shelli E. Stoker, Vice President and Assistant General Counsel, Novant Health Legal Department

• Understanding State Law Variability–Overview of examples of state-specific peer review protections, privileges, and reporting requirements that impact multi-state health care organizations
• Legal and Compliance Challenges–How differing state laws may affect information sharing, confidentiality, and risk exposure in peer review processes
• Strategic Approaches to Compliance–Options for structuring peer review and when to apply state law vs. federal protections (PSQIA)
• Practical Considerations and Case Studies–Hypotheticals that discuss pros and cons of sharing information
• Waivers and Risk Management–When, why, and how organizations may consider waiving peer review protections and the legal risks involved
• Balancing Factors in Decision-Making–Key considerations for legal, operational, and patient safety goals when structuring multi-state peer review processes

Lona Fowdur, Founding Partner, Econic Partners
Alexis Gilman, Crowell  & Moring LLP
Mitch Glende, Senior Counsel, Intermountain Health

Common activities of hospitals and health systems can raise antitrust issues more frequently than some might realize. This introductory-level presentation will help in-house counsel identify common antitrust issues and provide practical guidance to mitigate risk. The session will cover the following hot topics:

• Dos and Don’ts for meetings and collaborations with competitors, information sharing, and benchmarking
• Potential concerns arising from managed care contracting, including the use of anti-tiering, anti-steering, or all-or-nothing clauses
• Potential risks areas in the human resources context, including wage fixing, no-poach agreements, and noncompete and non-solicitation clauses
• Issue spotting for mergers and acquisitions, joint ventures, and other affiliations
• When to add an economist to your risk review team

Tynan Kugler, PYA, PC
Mara Smith-Kouba, Counsel, Regulatory Law, Bristol Myers Squibb

Medical device, pharmaceutical, laboratory, and biotech arrangements continue to garner the attention of regulators and failure to compliantly engage with physicians, advanced practice providers, and other professionals can bring False Claims Act actions against life sciences companies. As a result, organizations should consistently evaluate the reasons for, and risks associated with developing and implementing programs that provide value to referral sources and structure such arrangements to avoid improper interactions. This presentation will discuss:

• Current key regulatory and compliance considerations associated with various recent settlements and describe the implications in practice
• Best practices regarding development, implementation, and maintenance of common referral source arrangements such as key opinion leader engagement, marketing services arrangements, physician-owned distributorships, among others
• Critical components to mitigate undue influence
• In-house and external perspectives on establishing and operationalizing relationships in a compliant manner

Jeffrey I. Davis, Bass Berry & Sims PLC
Michelle Rae Pinzon, Senior Associate General Counsel, Northwell Health

Hospitals and other “Covered Entities” benefit from discounted drug prices under the 340B Drug Pricing Program, which allows them to stretch scarce federal resources, reach more eligible patients, and provide more services for underserved populations. Recently, drug manufacturers have mounted a variety of challenges to the 340B Program, leading to uncertainty, the issuance by HRSA of new interpretations of applicable obligations, and numerous lawsuits that could change the 340B Program as we know it – and dramatically impact the finances of many Covered Entities. The session, which is intended for an intermediate/advanced audience with familiarity with the 340B Program, will cover the following hot topics:

• Ongoing Agency enforcement actions against 340B providers and/or manufacturers
• Current Litigation Landscape of the 340B Program
• Different Stakeholders’ Positions on 340B
• Proposed legislation related to 340B

Anna Whites, Anna Whites Law Office
Matt Wolfe, Baker Donelson

• Physical health providers, health systems and hospitals often struggle with how to handle behavioral health issues as they arise. Many facilities don't have staff trained to link those patients with existing services or local providers who can address those issues. This session will discuss simple and effective strategies to prepare providers for managing or effectively referring behavioral health patients
• The old fashioned division of health care into "physical" and "mental" health has become outdated. Today's practitioners need to learn to address the entire patient in a wholistic and coordinated manner. Building a  health care system that can cover all the care a patient needs is both simple and cost effective. Learn what providers need to know in order to facilitate care of the whole person
• Reimbursement for behavioral health care, particularly in the addiction space, can be challenging for novice providers. The session will include discussion of relevant billing concerns and best practices for effective coding of care

Andrew Reitz, Vice President, Compliance, Buckeye Health Plan (subsidiary of Centene Corporation)
Debra Rossi, VMG Health

• AI in Compliance Audits
• Consultant vs. Payer Perspectives
• Proactive Compliance Strategies
• Defensive Audit Strategies
• AI’s Impact on Provider Scrutiny
• Best Practices for AI in Compliance