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Annual Meeting

Schedule

This two and a half day program will be held in-person only. We are excited for attendees to connect and network in person.

Join us at the AHLA Annual Meeting, our premier health law education and networking event. This multi-day program provides expert, up-to-the-minute analysis of legal, regulatory, and operational challenges facing a wide range of health care stakeholders. Comprehensive in coverage, the AHLA Annual Meeting offers substantive, intermediate-to-advanced sessions presented by qualified speakers on an impressive variety of topics. 

 

Monday
Schedule

 

Tuesday
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Wednesday
Schedule

         

Saturday, June 22, 2024

2:00-6:00pm

Registration and Check-In
Register Early! Come to the AHLA Registration area to print out your badge.

 

Sunday, June 23, 2024

7:00 am-5:30 pm

Registration and Check-In
Come to the AHLA Registration area to print out your badge.

 
5:30-6:30 pm

Networking Reception—Welcome to a Monumental Annual Meeting, sponsored by CobbleStone Software
This event is included in the program registration; attendees, speakers, and registered adult, teen, and youth guests are welcome. +
Learn More

 

Monday, June 24, 2024

7:00 am-5:30 pm

Registration and Check-In
Come to the AHLA Registration area to print out your badge.

 
7:00-8:30 am

Continental Breakfast, sponsored by Nelson Mullins
This event is included in the program registration; attendees, speakers, and registered adult, teen, and youth guests are welcome.

 
8:00 am-12:00 pm General Session

8:00-8:30 am
State of the Association and Member Awards and Recognition Celebration
Patricia A. Markus, AHLA President, Nelson Mullins Riley & Scarborough LLP, Raleigh, NC
David S. Cade, AHLA Executive Vice President/Chief Executive Officer, Washington, DC


8:30-9:45 am
1. Fireside Chat: Transformation of the Health Care Industry,
sponsored by FTI Consulting
Michelle Johnson Tidjani (Moderator), Senior Executive Vice President, Chief Administrative Officer, CommonSpirit Health
Marc Harrison, MD, Co-Founder and CEO, Health Assurance Transformation Corporation
Richard Mattera, Chief Development Officer, UnitedHealth Group

More Information

  • How has the industry changed?
  • How will different segments of the industry navigate the changing landscape?
  • What are the key drivers of a successful transformation?
  • How can we drive quality, health care outcomes, and health equity?
  • How do you manage teams to balance business goals and legal/regulatory considerations?

9:45-10:00 am
Break, sponsored by LawVu


10:00 am-12:00 pm
2. Year in Review,
sponsored by American University Washington College of Law Health Law and Policy Program
S. Craig Holden, Baker Donelson Bearman Caldwell & Berkowitz PC, Baltimore, MD
Robert Homchick, Davis Wright Tremaine LLP, Seattle, WA
Cynthia F. Wisner, Associate Counsel, Trinity Health, Livonia, MI

More Information

  • 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!
 
12:00-1:30 pm 

Networking and Presentation Lunch
Tips and Best Practices for Effective Interactions when Working with the Government, sponsored by Initial Vll Consulting LLC
Carol Blackford, Executive Vice President of Payment and Health Care Delivery Policy, Advamed , Washington, DC
Gregory E. Demske, Goodwin Procter LLP, Washington, DC
Mark Polston, King & Spalding LLP, Washington, DC

More Information

  • Understanding the relevant government agency’s perspective and expectations
  • Avoiding pitfalls and counter-productive communications
  • The who, what, when, where, why (and whether) of talking with the government
This is not included in the program registration; there is an additional fee of $65; limited attendance; and pre-registration is required. Continuing Education Credits are not available.
 
1:45-2:45 pm Concurrent Sessions

3. I’ll Take LEGAL ETHICS for $200, Alex! (not repeated)     
Ritu Kaur Cooper, Hall Render Killian Heath & Lyman, Washington, DC
Dwayne Leslie, Senior Vice President and General Counsel, Adventist Health Care, Gaithersburg, MD

Teresa Williams, Adjunct Professor, University of Oklahoma College of Law, Oklahoma City, OK

More Information

  • 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!


4. A View from the EEOC: Legal and Strategic Perspectives from U.S. EEOC Commissioner Jocelyn Samuelson (not repeated)     
Rob Niccolini, Ogletree Deakins, Washington, D.C.
Jocelyn Samuels, Vice Chair and Commissioner, EEOC, Washington, DC

More Information

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

5. Artificial Intelligence: Recent Developments and Hot Topics    
Vanessa Burrows, Simpson Thacher & Bartlett LLP, Washington, DC
Ty Kayam, Attorney, Microsoft Corporation, Seattle, WA
René Quashie, Vice President, Digital Health Consumer Technology Association, producer of CES®

More Information

This panel will discuss recent Administration actions, regulatory developments, and hot topics on the use and oversight of AI in health care, including:

  • Implementation of President Biden’s 2023 Executive Order
  • HHS and FDA actions
  • State legislative proposals
  • Enforcement actions and liability
  • Governmental and third-party standards on uses of AI in health care

6. Private Equity Under the Regulatory Microscope
Charlene K. Fullmer, Assistant US Attorney, Deputy Chief Civil Division, US Attorney’s Office for the Eastern District of PA, Philadelphia, PA     
John Kelly, Barnes & Thornburg, Washington, DC  
Kim Looney, K&L Gates, Nashville, TN 

More Information

  • 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

7. Patient Engagement: Strategic Considerations for Providing Tools and Supports to Patients to Promote Care Coordination and Advance Value-Based Care    
Samantha C. Flanzer, Lead Counsel with Walmart Health & Wellness, Washington, DC
Stewart W. Kameen, Bass Berry & Sims, Washington, DC
Amy H. Kearbey, Winston & Strawn, Washington, DC

More Information

  • 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

8. Cracks in Provider/Payer Relations: How to Prepare for Disputes and Resolve Them        
Yemi O. Adeyanju, Vice President, Division Senior Corporate Counsel - South, Providence Health, Irvine, CA
Jolee H. Bollinger, Deputy General Counsel, Sharp HealthCare, San Diego, CA    
Andrew D. Ruskin, K&L Gates, Washington, DC

More Information

  • 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
 
2:45-3:15 pm

Networking Coffee Break, sponsored by SCH Services, Inc.

 
3:15-4:15 pm  Concurrent Sessions 

9. Nowhere To Go: Navigating Complex Patient Discharges (not repeated)    
Jessica P. Barth, Senior Health System Counsel, MultiCare Health System, Indianapolis, IN
Emma P. Pelkey, Epstein Becker & Green PC, Portland, OR

More Information

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

10. The World of Alternative Substances in Health Care: The Rise in Interest for Use of Cannabis, Ketamine, and Psychedelics (psilocybin/MDMA) as Emerging Therapies by Practitioners (not repeated)     
Richard Y. Cheng, Ritter Spencer Cheng, PLLC, Addison, TX
Lisa Gora, Epstein Becker & Green PC, New York, NY

More Information

  • 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

11. Top Ten IRS Audit Risks for Nonprofit Health Care Organizations    
Gerald Griffith, Jones Day, Chicago IL, Detroit MI
Stephanie N. Switzer, Senior Counsel, Cleveland Clinic, Beachwood, OH

More Information

As if the nonprofit hospital sector were not facing enough challenges, the IRS appears ready to ramp up its enforcement activity. In the recently released program letter for FY2024, IRS Tax-Exempt/Government Entities stated it is focusing on expanded enforcement of the tax laws against taxpayers with complex filings and potential high-dollar noncompliance, singling out tax-exempt hospitals in particular as a focus of smarter, data-driven enforcement by the IRS. Translation - this is an effort to better identify and target examinations to returns that have the highest potential for generating tax liability, which could include significant UBIT, employment tax, and excise tax.

This session will review – Top Ten style – common audit risks for nonprofit health care organizations and how to minimize the potential tax exposure

  • Ten significant exposure areas for nonprofit health care organizations under IRS audit
  • Strategies to avoid audit triggers
  • Mock audits as a compliance tool
  • Educating the business team and governance on potential tax exposures
  • Adopting a team approach to audit defense

12. The New Antitrust Agenda for Health Care Mergers (Advanced)   
Cory Capps, Bates White, Washington, DC
Lisl Dunlop, Axinn, New York, NY
Karen Hunt, Deputy Assistant Director, Mergers IV, Federal Trade Commission, Washington, DC
Christine L. White, Vice President Office of Legal Affairs Northwell Health, Inc., Hyde Park, NY

More Information

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?

13. Tips and Takeaways from OIG’s General Compliance Program Guidance: A Moderated Q&A Session    
Amanda W. Copsey, Senior Counsel, Office of the Inspector General, US Department of Health and Human Services, Washington, DC    
Laura E. Ellis, Senior Counsel, Office of the Inspector General, US Department of Health and Human Services, Washington, DC
Catherine A. Martin (Moderator), Chief Compliance Officer Luminis Health, Baltimore, MD

More Information

  • 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

14. The Physician Self-Referral Law: Pitfalls, Potholes, and Possibilities    
Nicholas F. Alarif, McDermott Will & Emery LLP, Washington, DC  
Matthew Edgar, Acting Director, Division of Technical Payment Policy, Centers for Medicare and Medicaid Services, Windsor Mill, MD

More Information

  • 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
 
4:30-5:30 pm Concurrent Sessions 

15. No More Surprises: Complying with Hospital Price Transparency, Transparency in Coverage, and No Surprises Act Requirements Three Years Out (not repeated)     
Stephanie M. Hoffmann, Bradley Arant Boult Cummings LLP, Nashville, TN
Alexandra Shalom, Foley & Lardner LLP, Boston, MA

More Information

  • 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

16. Advanced Care at Home: Understanding Legal Risks for This New Care Delivery Model (not repeated)     
Jacob Harper, Morgan Lewis & Bockius LLP Washington, DC
Lisa Tripp, Professor Emeritus, Atlanta’s John Marshall Law School, Atlanta, GA

More Information

  • The beginning of At Home programs
  • CMS At Home Waiver development and current requirements
  • Technical challenges (telehealth and RPM considerations)
  • Legal risks associated with caring for acute patient in non-traditional setting
  • Reimbursement challenges and considerations
  • Legislative progress for another extension of the waiver

17. Navigating the Increasingly Complicated World of Heath Care Privacy    
Deven McGraw, Chief Regulatory & Privacy Officer, Ciitizen, San Francisco, CA
Kirk Nahra, WilmerHale, Washington DC

More Information

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.


18. Preparing and Advising Not-for-Profit Health Systems in A Change of Control Transaction to Support Regulatory Approval Processes    
Michael Barry, Arnall Golden Gregory, Atlanta, GA  
Annapoorani Bhat, Principal, PYA PC, Charlotte, NC

More Information

  • 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

19. “Fix It, Disclose It, or Pretend It Didn’t Happen”–The New Fraud & Abuse Game Show (Advanced)
Karen S. Glassman, Office of Inspector General, US Department of Health and Human Services, Washington, DC
William T. Mathias, Bass, Berry & Sims, Washington, DC    
Lisa O. Wilson, Senior Technical Advisor, Centers for Medicare and Medicaid Services, Baltimore, MD

More Information

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

20. Health Care on Trial: The Ripple Effect of Class Action Lawsuits in Health Care    
Archana Rajendra, Vice President, Deputy General Counsel, HAP, a subsidiary of Henry Ford Health
Gerard M. Stegmaier, ReedSmith, Washington, DC
Mackenzie S. Wallace, Thompson Coburn, Dallas, TX

More Information

  • 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
 
5:30-6:30 pm

Networking Reception—Taking Pride in Our Diversity, sponsored by VMG Health
In-Kind Support from Hispanic National Bar Association, National Asian Pacific American Bar Association and
South Asian Bar Association

This event is included in the program registration; attendees, speakers, and registered adult, teen, and youth guests welcome.+ Learn More

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Tuesday, June 25, 2024

6:30-7:30 am

Exercise Activities
Fun Run,
hosted by Early Career Professionals Council
Start the day off with a fun run around the nations capitol! Pre-registration is required

OR

Bollywood Class
Start the day off with an invigorating workout to get you through a full day of learning. Pre-registration is required; space for the class is limited.

There is no additional charge for these events. Attendees, speakers, and registered adult, teen and youth guests are welcome.

 
7:00 am-5:30 pm

Registration and Check-In
If you haven't checked in, come to the AHLA Registration area to print your badge.

 
7:00-8:30 am

Continental Breakfast, sponsored by Norton Rose Fulbright US LLP
This event is included in the program registration; attendees, speakers, and registered adult, teen, and youth guests welcome.

 
8:00-9:00 am Concurrent Sessions

21. Health Care Innovation: Representing Digital Health Start-Ups, Investors, and Innovators (not repeated)   
Anjali B. Dooley, Duncan Bergman Mandell, LLC, Saint Louis, MO
Ryan S. Johnson, Fredrikson & Byron, Minneapolis, MN  

More Information

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.

22. Gender Affirming Care and State and Federal Laws: Opportunities and Responsibilities in an Evolving Landscape (not repeated)   
Amy Magnano, Morgan Lewis & Bockius, Seattle, WA  
Trent Stechschulte, Chief Legal Officer & General Counsel, I Am Boundless, Inc. Worthington, O

More Information

  • 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

23. Oh Behave! You’d Better Be Prepared for the New SUD Confidentiality Rules    
Jud DeLoss, Chief Executive Officer/General Counsel, Illinois Association for Behavioral Health, Springfield, IL
Marc Goldstone, Executive Vice President and Chief Legal Officer, Wellpath, Nashville, TN

More Information

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

24. The Long and Winding Road: Current Perspectives in Value Based Care and Payment: Where Are We Now, and Where Are We Going? (Advanced) 
Michael Crum, Associate General Counsel, Wellvana, Nashville, TN
Hal McCard, Spencer Fane LLP, Nashville, TN
Jeffrey G. Micklos, Executive Director Health Care Transformation Task Force, Washington, DC
Purva Rawal, Chief Strategy Officer, Center for Medicare and Medicaid Innovation, Washington, DC

More Information

  • 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?

25. Everything Everywhere All at Once: Hidden Lessons from the Medical Staff Space (Advanced) 
Alexis Angell, Polsinelli PC, Dallas, TX  
William "Bill" George, System Corporate Counsel, CommonSpirit Health, Lexington, KY
Lindsey Ridgway, VP Deputy General Counsel, INTEGRIS Health, Oklahoma City, OK  

More Information

  • 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

6. Private Equity Under the Regulatory Microscope (repeat)
Charlene K. Fullmer, Assistant US Attorney, Deputy Chief Civil Division, US Attorney’s Office for the Eastern District of PA, Philadelphia, PA     
John Kelly, Barnes & Thornburg, Washington, DC  
Kim Looney, K & L Gates, Nashville, TN

More Information

  • 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
 
9:00-9:30 am

Networking Break, sponsored by Ballard Spahr

 
9:30-10:30 am Concurrent Sessions

 26. The Wild West of Antitrust in Health Care: An Overview of Recent Developments (not repeated)
Elizabeth R. Odette, Assistant Attorney General, Manager, Antitrust Division, Office of Minnesota Attorney General Keith Ellison, St. Paul, MN
Bryan J. Perry, Senior Managing Director, FTI Center for Healthcare Economics and Policy, Washington, DC
Chris Shea, Deputy General Counsel, Memorial Hermann Health System, Houston, TX
Amanda Wait, DLA Piper, Washington, DC

More Information

Federal and state antitrust agencies have made significant changes in the past year that impact almost all health care companies. These include:

  • Changes to how mergers and acquisitions are reported and the theories under which they are reviewed
  • Increased attention to ownership in health care, including heightened scrutiny of private equity “roll-ups” and potential director interlocks
  • An increased focus on impacts on workers, including banning almost all noncompete agreements
  • Continued focus on exclusionary and potentially collusive conduct impacting health care

27. Retail Health and Health Equity (not repeated) 
Kirk L. Dobbins (Moderator), Vice President and Regional Counsel, Kaiser Permanente, Portland, OR
Rujul Desai, Covington & Burling, Washington, DC
Elysia Solomon, Group Vice President – Privacy, Digital and Health Law, Albertsons, Washington, DC


28. Clinical Deficiencies and Behavioral Misconduct; Physician Discipline in a Hospital and Health System Setting
Charlie J. Chulack, Horty Springer & Mattern PC, Pittsburgh, PA
Jacob Theis, Associate General Counsel, Penn State Health, Hershey, PA

More Information

  • 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

29. Emerging Governance Trends: Has your Board Kept up with the Jones?    
Sandra M. DiVarco, McDermott Will & Emery LLP, Chicago, IL
Robert A. Gerberry, Chief Legal Officer, Summa Health, Akron, OH

More Information

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

30. Enforcement Under the False Claims Act 15 Years after FERA
Michael D. Granston, Deputy Assistant Attorney General (Commercial Litigation Branch), US Department of Justice, Washington, DC
Laura F. Laemmle-Weidenfeld, Jones Day, Washington, DC

More Information

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

31. Information Blocking and TEFCA
Mark A. Knee, Deputy Director, Interoperability Division, ONC, HHS, Washington, DC
Michael L. Lipinski, Director, Regulatory and Policy Affairs Division, Office of Policy, ONC, DHHS, Washington, DC
Elise Sweeney Anthony, Executive Director, Office of Policy, ONC, DHHS, Washington, DC

More Information

  • 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
 
10:30-11:00 am 

Networking Break

 
11:00 am-12:00 pm Concurrent Sessions

32. Arbitrating Payer/ Provider Disputes: A View from the Bench (Advanced) (not repeated)     
A. Joel Richlin, US Magistrate Judge, Central District of California, Los Angeles, CA  
Lisa D. Taylor, Inglesino Taylor, Boca Raton, FL  
Stuart M. Widman, Founder, Widman Law Offices, Chicago, IL

More Information

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

33. Know Your Audit! Operational Considerations Under Every Kind of Audit (Advanced) (not repeated)    
R. Ross Burris, Polsinelli PC, Atlanta, GA
Lindsey Lonergan, Vice President and Deputy General Counsel, Atrium Health Navicent, Macon, GA    

More Information

  • 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

34. Professionalism in Modern Times: The Ethical Considerations of Lawyering with Social Media, AI, Text Messaging, and Other Modern Technologies + How to Use Such Technologies to Advance Your Career    
Faith Driscoll, Chief Legal Officer, United Health Centers of the San Joaquin Valley, Fresno, CA
Caitlin Forsyth, Davis Wright Tremaine LLP, Portland, OR
Elle Karimkhani, Chief Legal Officer, Marshall Medical, Placerville, CA

More Information

  • 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

35. Beyond HIPAA: Health Care Sector Cybersecurity Requirements  
Paul Curylo, Chief Information Security Officer, Inova Health System, Sterling, VA
Harley Geiger, Venable LLP, Washington, DC   
Bezawit Sumner, CISO and Sr. Director of Security & Compliance, CRISP Shared Services, Columbia, MD    

More Information

  • 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

36. Virtual Reality: Hot Topics and Trends in Telehealth and Remote Service Arrangements  
Catherine L. Allison, Assistant General Counsel, Office of Legal Counsel/Health Affairs, University of Kentucky, Lexington, KY
Allison M. Cohen, Baker Donelson Bearman Caldwell & Berkowitz PC, Washington, DC  
Gayle R. Lee, Senior Director, Policy and Regulatory at the Association of American Medical Colleges, Vienna, VA  

More Information

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


8. Cracks in Provider/Payer Relations: How to Prepare for Disputes and Resolve Them (repeat) 
Yemi O. Adeyanju, Vice President, Division Senior Corporate Counsel - South, Providence Health, Irvine, CA    
Jolee H. Bollinger, Deputy General Counsel, Sharp HealthCare, San Diego, CA
Andrew D. Ruskin, K&L Gates, Washington, DC                            

More Information

  • 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
 
12:00-1:30 pm 

Networking and Presentation Lunch
Health Legislation/Policy Priorities in an Election Year, sponsored by Seyfarth Shaw LLP
Sonja Nesbit, Arnold & Porter, Washington, DC  
Jennifer Friedman, Senior Vice President, Federal Health Policy Strategies, Washington, DC

Carlos Jackson, Principal, Cornerstone, Washington, DC    

More Information

  • How do we expect the Biden Administration to wrap up their regulatory agenda by the end of the year?
  • What is likely to happen in Congress by the end of the year and/or during a lame duck session?
  • What might President’s Biden health care policy agenda look like in a second term?
  • How might a second Trump Administration look in terms of health care policy? What kind of groundwork is being laid right now in constructing an agenda?
  • What are some of the initiatives taking place in the developing a regulatory framework around the use of AI in the health industry? How might President Trump approach the use of AI in health care?
This is not included in the program registration; there is an additional fee of $65; limited attendance; and pre-registration is required. Continuing Education Credits are not available.
 
1:45-2:45 pm Concurrent Sessions 

37. The Americans with Disabilities Act in Health Care Settings (not repeated)     
Steven E. Gordon, United States Department of Justice, United States Attorney's Office for the Eastern District of Virginia, Alexandria, VA

More Information

  • 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

38. What Hospitals Need to Know to Partner with Physicians in the Dobbs Era: Managing Risk in the Face of Legal Uncertainty (not repeated)   
Annalia Michelman, Senior Legislative Attorney, American Medical Association, Chicago, IL
Michelle Oberman, JD,  MPH, Katharine and George Alexander Professor of Law, Santa Clara University School of Law, Santa Clara, CA

Delphine O'Rourke, Lead Partner, FemTech Fund III, Portfolia, New York, NY

More Information

  • 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

39. Through the Looking Glass: Bringing Alternative Physician Arrangements and Other Trending Life Sciences Topics Into Focus (Advanced)
Mara Smith Kouba, Counsel, Commercialization and Development at Bristol Myers Squibb, Philadelphia, PA
Tynan O. Kugler, PYA, PC, Atlanta, GA
Jonathan A. Porter, Husch Blackwell LLP, Savannah, GA    

More Information

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

7. Patient Engagement: Strategic Considerations for Providing Tools and Supports to Patients to Promote Care Coordination and Advance Value-Based Care (repeat)
Stewart W. Kameen, Bass Berry & Sims PC, Washington, DC
Amy H. Kearbey, Winston & Strawn, Washington, DC    
Samantha C. Flanzer, Lead Counsel with Walmart Health & Wellness, Washington, DC                               

More Information

  • 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

20. Health Care on Trial: The Ripple Effect of Class Action Lawsuits in Health Care (repeat)
Archana Rajendra, Vice President, Deputy General Counsel, HAP, a subsidiary of Henry Ford Health
Gerard M. Stegmaier, ReedSmith, Washington, DC
Mackenzie S. Wallace, Thompson Coburn, Dallas, TX

More Information

  • 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

25. Everything Everywhere All at Once: Hidden Lessons from the Medical Staff Space (Advanced) (repeat)  
Alexis Angell, Polsinelli, Dallas, TX  
William "Bill" George, System Corporate Counsel, CommonSpirit Health, Lexington, KY
Lindsey Ridgway, VP Deputy General Counsel, INTEGRIS Health, Oklahoma City, OK                              

More Information

  • 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
 
2:45-3:15 pm 

Networking Snack Break, sponsored by Ankura

 
3:15-4:15 pm Concurrent Sessions 

40. De-Mystifying De-Identification: Understanding Divergent US and Global Standards (not repeated)
David J. Peloquin, Ropes & Gray LLP, Boston, MA
Kristen B. Rosati, Coppersmith Brockelman PLC, Phoenix, AZ
Ann B. Waldo, Waldo Law Offices, PLLC, Washington, DC

More Information

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

41. Apportioning Risk: Representations and Warranties in Health Care Transactions, Practical Skills (Interactive) (not repeated)     
Purvi Badiani Maniar, Norton Rose Fulbright, Saint Louis, MO
Ari J. Markenson, Venable, New York, NY  

More Information

  • 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

11. Top Ten IRS Audit Risks for Nonprofit Health Care Organizations (repeat) 
Gerald Griffith, Jones Day, Chicago IL, Detroit, MI
Stephanie N. Switzer, Senior Counsel, Cleveland Clinic, Beachwood, OH      

More Information

As if the nonprofit hospital sector were not facing enough challenges, the IRS appears ready to ramp up its enforcement activity. In the recently released program letter for FY2024, IRS Tax-Exempt/Government Entities stated it is focusing on expanded enforcement of the tax laws against taxpayers with complex filings and potential high-dollar noncompliance, singling out tax-exempt hospitals in particular as a focus of smarter, data-driven enforcement by the IRS. Translation - this is an effort to better identify and target examinations to returns that have the highest potential for generating tax liability, which could include significant UBIT, employment tax, and excise tax.

This session will review – Top Ten style – common audit risks for nonprofit health care organizations and how to minimize the potential tax exposure

  • Ten significant exposure areas for nonprofit health care organizations under IRS audit
  • Strategies to avoid audit triggers
  • Mock audits as a compliance tool
  • Educating the business team and governance on potential tax exposures
  • Adopting a team approach to audit defense

14. The Physician Self-Referral Law: Pitfalls, Potholes, and Possibilities (repeat)
Nicholas F. Alarif, McDermott Will & Emery LLP, Washington, DC
Matthew Edgar, Acting Director, Division of Technical Payment Policy, Centers for Medicare and Medicaid Services, Windsor Mill, MD                        

More Information

  • 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

17. Navigating the Increasingly Complicated World of Heath Care Privacy (repeat) 
Kirk Nahra, WilmerHale, Washington DC  
Deven McGraw, Chief Regulatory & Privacy Officer, Ciitizen, San Francisco, CA                               

More Information

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.


30. Enforcement Under the False Claims Act 15 Years after FERA (repeat)  
Michael D. Granston, Deputy Assistant Attorney General (Commercial Litigation Branch), US Department of Justice, Washington, DC
Laura F. Laemmle-Weidenfeld, Jones Day, Washington, DC

More Information

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
 
4:30-5:30 pm Concurrent Sessions 

42. Drug Pricing Policy and Practices in the Courts (not repeated)     
Kristyn DeFilipp, Foley Hoag, Boston, MA
Amanda Smith, Legal Counsel, 340B Health, Washington, DC

More Information

Spending on prescription drugs has steadily increased over the past several decades. The causes are myriad and virtually every player in the health care economy is a stakeholder: Developers and manufacturers, distributors, public and private payors, prescribers, pharmacies and, of course, patients. In recent years, many of these stakeholders have tried to tackle the problem of prescription spending. The solutions have often led to litigation, ranging from impact litigation against federal and state governments to civil litigation among private parties.
Our session will update attendees on drug pricing litigation in the courts. Although the topic is sure to evolve before June, we would expect to cover:

  • Recent challenges to the Inflation Reduction Act
  • Challenges to state attempts to regulate drug pricing and pharmacy benefit managers
  • Key private litigations including litigations challenging alternative funding vendors
  • Significant litigation involving the 340B program

43. AI in Health Care: An Employment Law and HR Perspective (Advanced) (not repeated)     
Jenn Betts, Ogletree Deakins, Pittsburgh, PA
Gary McLaughlin, Mitchell Silberberg & Knupp LLP, Los Angeles, CA

More Information

In the ever-evolving health care industry, the integration of artificial intelligence (AI) is presenting both unprecedented opportunities and unique challenges. As health care attorneys and human resources professionals, your roles are pivotal in ensuring that AI solutions are seamlessly incorporated into the workplace while safeguarding compliance and ethical practices. Join us for an enlightening presentation that will delve into the intersection of AI, health care, and the legal and HR domains. By attending this presentation, you will gain valuable insights into AI’s key implications as they relate to recruitment, hiring, wage & hour, labor relations, data privacy, confidentiality, and more.


13. Tips and Takeaways from OIG’s General Compliance Program Guidance: A Moderated Q&A Session (repeat)      
Catherine A. Martin (Moderator), Chief Compliance Officer Luminis Health, Baltimore, MD
Amanda W. Copsey, Senior Counsel, Office of the Inspector General, US Department of Health and Human Services, Washington, DC
Laura E. Ellis, Senior Counsel, Office of the Inspector General, US Department of Health and Human Services, Washington, DC                 

More Information

  • 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

28. Clinical Deficiencies and Behavioral Misconduct: Physician Discipline in a Hospital and Health System Setting (repeat)      
Charlie J. Chulack, Horty Springer & Mattern PC Pittsburgh, PA
Jacob Theis, Associate General Counsel, Penn State Health, Hershey, PA             

More Information

  • 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

31. Information Blocking and TEFCA (repeat)
Mark A. Knee, Deputy Director, Interoperability Division, ONC, HHS, Washington, DC
Michael L. Lipinski, Director, Regulatory and Policy Affairs Division, Office of Policy, ONC, DHHS, Washington, DC
Elise Sweeney Anthony, Executive Director, Office of Policy, ONC, DHHS, Washington, DC               

More Information

  • 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

36. Virtual Reality: Hot Topics and Trends in Telehealth and Remote Service Arrangements  (repeat)  
Catherine L. Allison, Assistant General Counsel, Office of Legal Counsel/Health Affairs, University of Kentucky, Lexington, KY
Allison M. Cohen, Baker Donelson Bearman Caldwell & Berkowitz PC, Washington, DC  
Gayle R. Lee, Senior Director, Policy and Regulatory at the Association of American Medical Colleges, Vienna, VA                 

More Information

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

 
6:30-9:30 pm 

National Museum of African American History and Culture Reception, sponsored by AHLA’s Members’ Law Firms
This event is included in the program registration; attendees, speakers, and registered adult, teen, and youth guests welcome.
Transportation will be provided.
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Wednesday, June 26, 2024

7:00 am-12:30 pm

Registration and Check-In
If you haven’t checked in, come to the AHLA Registration area to print your badge.

 
7:00-8:30 am

Continental Breakfast
This event is included in the program registration; attendees, speakers, and registered adult, teen and youth guests welcome.

 
7:00-7:50 am

Women's Networking Breakfast, sponsored by Pinnacle Healthcare Consulting and hosted by Women’s Leadership Council
This event is included in the program registration; attendees and speakers are welcome. Pre-registration is required; space is limited. 
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8:00-9:45 am General Session

8:00-8:45 am
44. Keynote Address: Artificial Intelligence and Health Care

Brian Anderson, MD, Chief Executive Officer, Coalition for Health AI (CHAI), Boston, MA

More Information

  • How is AI transforming health care
  • How different stakeholders are approaching AI and including AI in their business strategies
  • What use cases are being invested in
  • What's driving a responsible approach to the use of AI

8:45-9:45 am
45. Meet the Government: Enforcement Priorities, Trends, Challenges, and Opportunities
David S. Cade (Moderator), Executive Vice President/Chief Executive Officer, American Health Law Association, Washington, DC
Nitin Natarajan, Deputy Director, Cybersecurity and Infrastructure Security Agency, Department of Homeland Security, Washington, DC
Eli Tomar, JD, MPH, Deputy Chief of Staff, Office of the Commissioner, US Food and Drug Administration, Washington, DC
Vaishali Udupa, Commissioner for Patents, US Patent and Trademark Office, Alexandria, VA

More Information

This panel discussion will highlight the work of the CISA, FDA, and USPTO and the impact on the health care industry. Panelists will discuss:

  • The role of each agency and its priorities and initiatives
  • Interplay with other agencies
  • The impact of artificial intelligence on the agencies’ work and on innovation
  • How to improve health outcomes
 
9:45-10:15

Networking Break

 
10:15-11:15 am Concurrent Sessions

5. Artificial Intelligence: Recent Developments and Hot Topics (repeat)
Vanessa Burrows, Simpson Thacher & Bartlett LLP, Washington, DC
Ty Kayam, Attorney, Microsoft Corporation, Seattle, WA
René Quashie, Vice President, Digital Health Consumer Technology Association, producer of CES®

More Information

This panel will discuss recent Administration actions, regulatory developments, and hot topics on the use and oversight of AI in health care, including:

  • Implementation of President Biden’s 2023 Executive Order
  • HHS and FDA actions
  • State legislative proposals
  • Enforcement actions and liability
  • Governmental and third-party standards on uses of AI in health care

12. The New Antitrust Agenda for Health Care Mergers (Advanced) (repeat)
Cory Capps, Bates White, Washington, DC
Lisl Dunlop, Axinn, New York, NY
Karen Hunt, Deputy Assistant Director, Mergers IV, Federal Trade Commission, Washington, DC
Christine L. White, Vice President Office of Legal Affairs Northwell Health, Inc., Hyde Park, NY

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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?

29. Emerging Governance Trends:  Has your Board Kept up with the Jones? (repeat)
Sandra M. DiVarco, McDermott Will & Emery LLP, Chicago, IL
Robert A. Gerberry, Chief Legal Officer, Summa Health, Akron, OH  

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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

34. Professionalism in Modern Times: The Ethical Considerations of Lawyering with Social Media, AI, Text Messaging, and Other Modern Technologies + How to Use Such Technologies to Advance Your Career (repeat)
Faith Driscoll, Chief Legal Officer, United Health Centers of the San Joaquin Valley, Fresno, CA
Caitlin Forsyth, Davis Wright Tremaine LLP, Portland, OR
Elle Karimkhani, Chief Legal Officer, Marshall Medical, Placerville, CA

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  • 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

39. Through the Looking Glass: Bringing Alternative Physician Arrangements and Other Trending Life Sciences Topics Into Focus (Advanced) (repeat)
Mara Smith Kouba, Counsel, Commercialization and Development at Bristol Myers Squibb, Philadelphia, PA
Tynan O. Kugler,  Principal, PYA, PC, Atlanta, GA
Jonathan A. Porter, Husch Blackwell LLP, Savannah, GA  

 
11:30 am-12:30 pm Concurrent Sessions

18. Preparing and Advising Not-for-Profit Health Systems in A Change of Control Transaction to Support Regulatory Approval Processes (repeat)
Michael Barry, Arnall Golden Gregory, Atlanta, GA
Annapoorani Bhat, Principal, PYA PC, Charlotte, NC

More Information

  • 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

19. “Fix It, Disclose It, or Pretend It Didn’t Happen” – The New Fraud & Abuse Game Show (Advanced) (repeat)
Karen S. Glassman, Office of Inspector General, US Department of Health and Human Services, Washington, DC
William T. Mathias, Bass, Berry & Sims, Washington, DC    
Lisa O. Wilson, Senior Technical Advisor, Centers for Medicare and Medicaid Services, Baltimore, MD

More Information

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

23. Oh Behave! You’d Better Be Prepared for the New SUD Confidentiality Rules (repeat)
Jud DeLoss, Chief Executive Officer/General Counsel, Illinois Association for Behavioral Health, Springfield, IL
Marc Goldstone, Executive Vice President and Chief Legal Officer, Wellpath, Nashville, TN

More Information

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

24. The Long and Winding Road: Current Perspectives in Value Based Care and Payment: Where Are We Now, and Where Are We Going? (Advanced) (repeat)
Michael Crum, Associate General Counsel, Wellvana, Nashville, TN
Hal McCard, Spencer Fane LLP, Nashville, TN
Jeffrey G. Micklos, Executive Director Health Care Transformation Task Force, Washington, DC
Purva Rawal, Chief Strategy Officer, Center for Medicare and Medicaid Innovation, Washington, DC

More Information

  • 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?

35. Beyond HIPAA: Health Care Sector Cybersecurity Requirements (Advanced) (repeat)
Paul Curylo, Chief Information Security Officer, Inova Health System, Sterling, VA
Harley Geiger, Venable LLP, Washington, DC   
Bezawit Sumner, CISO and Sr. Director of Security & Compliance, CRISP Shared Services, Columbia, MD 

More Information

  • 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

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In-Person Program Format

How It Works

  • We will offer in-depth breakout sessions where speakers and attendees can interact and collaborate with each other in-person.
  • We have adopted a new onsite registration system by providing seamless check-in and onsite badge printing.
  • Built-in extended time between sessions for moving from room to room, networking with colleagues, and personal break time.  
  • All program sessions will be recorded. Video of the presentations, along with the materials will be available to all attendees who register and can be watched to earn. On Demand Continuing Education Credits. Those that cannot attend in-person can purchase the eProgram and apply for Continuing Education Credits. More information on our ePrograms.
  • For questions or more information, please email [email protected].