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Health Plan Law and Compliance Institute

Schedule

The legal and compliance teams advising health plans and payers face a unique set of challenges. Network with others who understand the demands on your role and take home solutions that will enable you to more effectively collaborate with your team.

Thursday Schedule

 

Friday Schedule

 

Thursday, May 16, 2024

12:00-5:00 pm

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

 
1:00-3:30 pm General Session

1:00-1:15 pm
Welcome and Introductions
Patricia Markus, AHLA President
Jane Susott, Program Chair


1:15-2:15 pm
1. Politics and Policy: Fireside Chat with Former Senator Richard Burr on Health Policy Issues to Watch During This Election Cycle
Senator Richard Burr, DLA Piper, Washington, DC
David S. Cade, Executive Vice President/Chief Executive Officer, American Health Law Association, Washington, DC

More Information

  • Discussion about recent and pending legislation impacting the health insurance and health care industries

  • A look forward to the 2024 elections and their implications for health plans and health care providers

  • How will new and innovative products coming to market change today’s coverage paradigm in the U.S.

  • Setting the table for 2025–how health plans and the health industry should prepare themselves for the new Congress (and potential new Administration)


2:30-3:30 pm
2. Federal Preemption of State Health Care Laws
Peter Fjelstad, Assistant Vice President, State Regulatory and Legal Affairs, PCMA, Washington, DC
Andrew London, Foley Hoag LLP, Boston, MA

More Information

This advanced-level discussion will explore the evolution of ERISA and Medicare Preemption in the past ten years, and the corresponding increase in state efforts to regulate the structure of health care benefits. We will cover state laws concerning provider network structures, PBMs, reproductive health care and gender-affirming care, and discuss how those laws intersect with federal preemption. We will also discuss trends among state departments of insurance, state attorneys general, and other state regulators in issuing regulations and pursuing enforcement activity in areas that potentially implicate federal preemption. This case will be framed in the context of recent appellate decisions in the space, including Supreme Court decisions from 2016 (Gobeille) and 2020 (Rutledge) and circuit court decisions following Rutledge.

 
3:30-4:00 pm

Networking Coffee Break
Exhibits Open–Meet the Exhibitors

 
4:00-5:00 pm General Session

3. Cutting Edge Developments in Health Insurance
David E. Kopans, DLA Piper LLP (US), Washington, DC
Larry Pliskin, SVP, Compliance & Associate General Counsel, Enhance Health, LLC, Sunrise, FL

More Information

This panel will examine the evolving cutting edge laws and technologies supporting innovation in the delivery of health insurance coverage in the United States, including:

  • Status of insurtechs

  • Online health insurance sales, marketing, and educational arrangements

  • Use of artificial intelligence tools in health insurance

  • Prescription discount cards and their impact on insurance coverage

  • Direct primary care arrangements as an alternative to insurance

  • Innovations in Medicare Advantage supplemental benefits

 
5:00-6:00 pm

Networking Reception, LegalSifter, Inc.
This event is included in the conference registration. Attendees, speakers, and registered guests are welcome.

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Friday, May 17, 2024

7:30 am-5:15 pm

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

 
7:30-8:30 am

Continental Breakfast
This event is included in the conference registration fee. Attendees, speakers, and registered guests are welcome.

 
8:30-9:30 am 

4. Regulators’ Perspectives (not repeated)
Frank Meyers, Deputy Legal Counsel, Federation of State Medical Boards, Washington, DC
Ayesha Rasheed, Attorney, Division of Privacy and Identity Protection, Federal Trade Commission, New York, NY
Jeffrey Smith, Deputy Director, Certification & Testing Division, Office of the National Coordinator, Washington, DC

More Information

This panel assembles key representatives from federal and state regulatory stakeholders to offer their perspectives on the evolving regulatory landscape for development and use of AI applications in health care. The FDA and ONC play a vital role in advancing safe, effective, interoperable and transparent health technology across the health ecosystem, leveraging their authorities, investments, and programs to guide industry. The FTC uses its authorities to support AI innovation that is pro-competitive and protects consumers. State medical boards play an important role in regulating the use of AI in care delivery, particularly when it comes to the practice of medicine by licensed physicians and other health care professionals. Hear firsthand how regulators evaluate and approach managing risk related to emerging AI use cases in health care using their existing authorities, and where they see gaps in existing regulatory frameworks.


5. Putting the Privacy Puzzle Pieces Together: HIPAA, Part 2, and State Consumer Privacy Laws (not repeated)
Christopher Carlson, Managing Counsel, Data & Privacy, Aledade, Inc., Chicago, IL
Thora Johnson, Orrick,Herrington & Sutclisse LLP, Baltimore, MD

More Information

The health privacy space has gotten more complicated. This session will address the interplay between HIPAA, Part 2, FTC Act, and the state consumer privacy laws. Specifically, we’ll discuss:

  • Whose is subject to what laws and how do those laws interact

  • Recent updates to these laws and enforcement trends

  • What these laws mean for health plans

  • What these laws mean for health plan participants, particularly when participants exercise their HIPAA right to access

  • Practical tips on helping navigate the patchwork of federal and state laws applicable to health data


6. Compliance Best Practices for Risk Delegation
Devin A. Cohen, Ropes & Gray LLP, Boston MA
Christina Steiner, Alvarez & Marsal, New York, NY

More Information

  • Medicare Advantage Organization (MAO) risk delegation to first tier, downstream, and related entities (FDRs), and applicable guidance from the Centers for Medicare and Medicaid Services (CMS)

  • Diligence considerations, including best practices prior to contracting and legal considerations for contracting

  • Routine monitoring and auditing protocols, including analysis of key metrics and service level agreements (SLAs) through routine reports/ dashboards from FDRs, annual delegation audits, and the annual risk assessment process

  • Best practices for responding to and managing FDR noncompliance, including tips for managing corrective actions, training, proper documentation, and reporting of the incidents/risks identified 

  • Implications for delegation based on regulatory and enforcement trends

 
9:45-10:45 am 

7. Data Governance and Privacy for Health AI: Consent, Transparency, and Ethics (not repeated)
Kristen Rosati (Moderator), Coppersmith Brockelman PLC, Phoenix, AZ
Devyani Biswal, Methodology Architect, Privacy Analytics
Grace Cordovano, PhD, Board Certified Patient Advocate, Enlightening Results, New York, NY
Mark Sendak, Duke Health, Durham, NC
Leah A. Voigt, Chief Compliance Officer, Corewell Health, Grand Rapids, MI

More Information

AI models are only as good as the data they're trained on and process. As such, data governance has a direct impact on efforts to plays a critical role in developing and using AI in ways that create fair, accurate, legally compliant, and socially beneficial outcomes that patients and the health care industry can trust.

This panel will delve into the critical issues surrounding data governance and privacy in the development, deployment, and use of AI in health care. A cross-functional panel of experts will share their insights on the following key areas:

  • Regulatory Landscape: Examining the existing and emerging regulations, guidelines, and best practices for ensuring responsible and ethical use of health data in AI systems.

  • Data Quality: Discussing the importance curating high-quality, representative data sets.

  • Privacy Considerations: Addressing the challenges of preserving patient privacy the role of consent in AI applications and use cases.

  • Operationalizing Ethical Frameworks: Exploring ethical principles, frameworks, and decision-making processes to guide privacy-protective AI use cases.

  • Stakeholder Engagement: Fostering collaboration and dialogue among healthcare providers, technologists, and patients to ensure transparency, accountability, and trust in AI systems.


8. Compliance and Litigation Implications of the New Proposed Mental Health Parity Act Regulations (not repeated)
Matthew Donze, Associate Chief Counsel, Cigna, Nashville, TN
Jason Mayer, Partner, Reed Smith LLP, Chicago, IL

More Information

The Department of Labor recently proposed a significant overhaul to the federal regulations governing non-quantitative treatment limitations (NQTLs) under the Mental Health Parity and Addiction Equity Act (MHPAEA). Matt Donze, Chief Counsel at Cigna, and Jason Mayer, a partner at Reed Smith who specializes in managed care, will provide an overview of the proposed new regulations and share their in-house and outside counsel perspectives on compliance challenges and the profound impact the regulations will have on ERISA litigation for health plans if adopted. The presentation will discuss:

  • The proposed changes to NQTL rules

  • Potential objections health plans can raise during the comment period

  • Compliance challenges presented by the new NQTL rules

  • The regulatory and litigation implications for health plans if the proposed regulations are adopted


9. Managed Care Litigation: Highlights and Trends
Andrea Verney Kerstein, Locke Lord LLP, Chicago, IL
Jeff J. Wurzburg, Norton Rose Fulbright US LLP, San Antonio, TX

More Information

This session will examine:

  • The recent wave of AI, data privacy, and other class actions against payors

  • The state, and possible future, of Chevron deference

  • Recent FCA cases in managed care

  • Other key decisions and emerging trends in litigation affecting MCOs and providers

 
10:45-11:15 am

Networking Coffee Break
Exhibits Open–Meet the Exhibitors

 
11:15 am-12:15 pm 

10. Managing Algorithmic Bias and Fairness (not repeated)
Brad M. Thompson (Moderator), Epstein Becker & Green PC, Washington, DC
Michael Shumpert, Mosaic Data Science, Reston, VA

More Information

Bias, a natural part of human nature, has traditionally impacted health care to create and maintain profound inequities. How we recognize, confront, and adjust to this reality has powerful implications with the dawn of artificial intelligence. Algorithms themselves, step-by-step procedures designed to solve specific problems and/or perform specific tasks are neither good nor bad, biased nor unbiased, but when infused with biased information or without recognition of existing bias, may further entrench healthcare inequities. This panel will address how to navigate bias in AI applications as well as various approaches to identify, mitigate, and monitor the impact of bias using various solutions throughout the AI lifecycle.


11. Legal Ethics: Counseling a Client on “Illegal” Conduct under Rule 1.2 [Scope of Representation of an Attorney]: Considerations to Assess When Looking To Provide Advice on Cannabis and/or Psychedelic Related Laws (not repeated)
Lisa Gora, Epstein Becker & Green PC, Edison, NJ
Don Parisi, President, Bennabis Health, Cranford, NJ

More Information

  • The ABA Model Rules of Professional Conduct 1.2(d) use of “criminal conduct” versus other state’s use of “illegal”

  • This rules applicability to emerging business models related to cannabis licensed businesses or psilocybin licensed businesses

  • Interpretation of “illegal” conduct as referenced by case law and advisory opinions addressing this issue

  • The increasing interest in use of cannabis and psychedelics for their therapeutic potential in treating mental health disorders and the movement towards legalization

  • How the increasing interest in these alternative substances as emerging therapies and how that suggests that these substances might become more mainstream and be considered for health coverage

  • Coverage and reimbursement for emerging therapies and pathways that lay the groundwork for potential insurance coverage in the future; discussion on the American Medical Association’s approval of insurance billing codes for psychedelic therapy and other considerations for coverage or non-coverage


12. The Provider's Role in Medicare Marketing - An Evolving Concept
Jennifer Hatchett, Hall Render Killian Heath & Lyman PC, Louisville, KY
Jennifer McGowen, Senior Counsel, Health Plans and Networks, CHRISTUS Health, Irving, TX

More Information

Providers have an inherent interest in ensuring that their patients enroll in a Medicare Advantage/Prescription Drug Plan that they participate in and/or which the patient's prescriptions are in formulary.

  • CMS provides limited guidance on providers' role in marketing outside the health care setting. How do providers navigate those waters without running afoul of CMS?

  • CMS has been actively modifying Medicare Advantage/PDP marketing rules over the past 2-3 years, how do those changes impact providers?

  • Recent enforcement actions and CMS commentary in the 2023 Final Rule indicates CMS is aware of provider marketing efforts - what can providers do to prepare for likely regulatory changes?

  • What is the role of the MA/PDP plan in overseeing provider marketing efforts?

 
12:15-1:30 pm 

Lunch on Your Own

 
1:30-2:30 pm 

13. Negotiating Key Contract Provisions for Health Care AI Tools (not repeated)
Kathleen Healy, Robinson + Cole LLP, Boston, MA
Ira Kalina, Faegre Drinker Biddle & Reath LLP, Chicago, IL

More Information

Companies are in the early stages of developing, contracting for and using AI tools. The industry is evolving so quickly that lawyers are trying to catch up to determine how to apply existing contractual protections to this new technology and evaluate new protections. This session will discuss key contracting considerations for health AI tools, including:

  • IP property rights

  • AI algorithms

  • Training data

  • Generated content

  • Assignment, licensing, etc.

  • Data ownership

  • AI Governance, transparency, and audit rights

  • Performance warranties

    • Including representations as to training data)/protections

  • Including the ability to evolve with changing laws

  • Ongoing monitoring/evaluation

    • Including proactively assessing potential bias

  • Insurance

  • Liability

  • Termination and exit strategies

  • Other contractual considerations within a continuously shifting regulatory environment


14. Navigating Privacy Challenges When Using Health Data to Develop AI (not repeated)
Adam Greene, Davis Wright Tremaine LLP, Washington, DC
Khadra Abdulkareem, Amazon Web Services, Arlington, VA

More Information

This session will explore how to navigate HIPAA, the Confidentiality of Substance Use Disorder Patient Records Rule at 42 C.F.R. Part 2, state general privacy laws, new state consumer health data laws (like Washington's My Health My Data Act), and state laws governing specific conditions and treatments when seeking to use and disclose health data to develop AI. Topics will include:

  • Whether the development of AI potentially constitutes "research" for purposes of HIPAA

  • The extent that business associates can use protected health information (PHI) to develop AI under typical business associate agreements

  • HIPAA's prohibition on the sale of PHI and its potential application to transactions between health care entities and technology companies to develop AI

  • Regulatory requirements on de-identified data that is sold or licensed for purposes of AI development

  • Categories of health data that raise additional privacy concerns if included in data sets for AI development (such as behavioral health data)


15. PBM Legal Trends Update and Compliance Considerations (not repeated)
Samantha Brown, The Phoenix Law Group, PLC, Scottsdale, AZ

More Information

  • Overview of State Law Landscape

    • Licensing/Reporting

    • Pharmacy Network

    • Plan Design/Formulary

    • Utilization Management

    • Privacy and Security

    • Reporting and Data Sharing

    • Business Practices

  • Discussion of Emerging Legal Trends

    • Transparency

    • Reporting

    • Pharmacy Protections (PBM Affiliates, AWP, Steerage, Minimum Pricing)

    • ERISA Scope Expansion

    • Government Audits, Investigations, Studies, and Enforcement Actions

  • Compliance Considerations

    • Tracking Requirements

    • Determining Applicability

      • Business Model

      • Line of Business

      • Scope of Requirements (Members in State, Plans Licensed/Sited in State, Pharmacies in State)

    • Compliance Impact Considerations

      • Service Offerings

      • Profitablity

      • Operational Burdens

      • Licensure/Reporting

 
3:00-4:00 pm 

16. Navigating Risk Dynamics between AI Developers, Health Care Organizations, Clinicians and Patients (not repeated)
Ammon Fillmore, AdventHealth Associate Chief Legal Officer: Information & Technology, Altamonte Springs, FL
Dale Kadlec, Lead Counsel, US Health and Life Sciences Division, Microsoft
Roma Sharma, Crowell & Moring LLP, Washington, DC


17. Writing on the Wall: What We Can Learn from Case Law and Enforcement Trends When AI Regulation Remains in Flux? (not repeated)
Kristopher Hult, Principal, Charles River Associates, Chicago, IL
Jonathan Porter, Husch Blackwell, Savannah, GA
Nathaniel Mendell, Morrison Foerster, Boston, MA

More Information

AI is increasingly used in health care and life sciences in a variety of clinical and non-clinical ways. With regulations often lagging behind technological advancements, it is imperative for legal practitioners to stay abreast of case law and enforcement trends in this domain. This presentation aims to evaluate relevant case law and enforcement actions pertaining to AI in health care as a means to identify key areas of risk and possible regulation moving forward. We will examine the antitrust implications of market consolidation implicating vast amounts of patient data as well as the use of patient data related to AI-based algorithmic pricing.  We will also examine recent government enforcement actions related to the use of AI in ways that could interfere with clinical decision-making to maximize profit.  We will also examine government enforcement in the false claims arena related to non-clinical applications of AI in the context of automation of medical claims submission.


9. Managed Care Litigation: Highlights and Trends (repeat)
Andrea Verney Kerstein, Locke Lord LLP, Chicago, IL
Jeff J. Wurzburg, Norton Rose Fulbright US LLP, San Antonio, TX

More Information

This session will examine:

  • The recent wave of AI, data privacy, and other class actions against payors

  • The state, and possible future, of Chevron deference

  • Recent FCA cases in managed care

  • Other key decisions and emerging trends in litigation affecting MCOs and providers


12. The Provider's Role in Medicare Marketing - An Evolving Concept (repeat)
Jennifer Hatchett, Hall Render Killian Heath & Lyman PC, Louisville, KY
Jennifer McGowen, Senior Counsel, Health Plans and Networks, CHRISTUS Health, Irving, TX

More Information

Providers have an inherent interest in ensuring that their patients enroll in a Medicare Advantage/Prescription Drug Plan that they participate in and/or which the patient's prescriptions are in formulary.

  • CMS provides limited guidance on providers' role in marketing outside the health care setting. How do providers navigate those waters without running afoul of CMS?

  • CMS has been actively modifying Medicare Advantage/PDP marketing rules over the past 2-3 years, how do those changes impact providers?

  • Recent enforcement actions and CMS commentary in the 2023 Final Rule indicates CMS is aware of provider marketing efforts - what can providers do to prepare for likely regulatory changes?

  • What is the role of the MA/PDP plan in overseeing provider marketing efforts?

 
4:15-5:15 pm 

18. Human Values for AI in Health Care (not repeated)
Dr. Monica Lopez, Co-Founder & CEO, Cognitive Insights for Artificial Intelligence, Baltimore, MD
Jessica Ross, Senior Government Affairs Lead, Unlearn.AI, San Francisco, CA
Drew Stevens, Parker Hudson Rainer & Dobs, Atlanta, GA

More Information

  • AI in health care can perpetuate discrimination if not implemented carefully. Providers should be aware of potential biases in data and algorithms. Current anti-discrimination laws and recent actions by the Biden administration aim to provide safeguards

  • The Human-Centered AI (HCAI) framework emphasizes incorporating human values and considerations into AI development and use. While beneficial, it also has limitations. Commercial AI health technologies show varying alignment with HCAI principles

  • AI "black box" models can be difficult to interpret and current metrics may not accurately reflect trustworthiness. Centering human considerations is proposed as a better approach for establishing appropriate reliance on AI models

  • Key considerations include: 1) Proactively identifying and mitigating sources of bias 2) Evaluating AI health tools through an HCAI lens 3) Prioritizing human values over opaque technical metrics in determining AI trustworthiness 4) Ongoing monitoring and adjustment as real-world impacts become apparent


19. Trustworthy AI (not repeated)
Jiayan Chen, McDermott Will & Emery LLP
Lauren Willens, Henry Ford Health

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In-Person Conference 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 conference 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].
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Program Accessibility and Special Needs

AHLA is committed to ensuring equitable access to our educational content. We are continually improving the user experience for everyone and offering accessibility accommodations for our in-person programs.

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Thank You to Our Health Plan Law and Compliance Institute Sponsors

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If your organization is interested in sponsoring AHLA's Health Plan Law and Compliance Institute, please contact Valerie Eshleman.