Schedule

• 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)

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.

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

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.

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

• 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

Good governance 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 governance in the development and use of AI in health care. A cross-functional panel of experts will share their insights on the following key areas:

• Ethical Frameworks: Developing ethical principles and decision-making processes to guide AI use cases
• Stakeholder Engagement: Fostering collaboration and dialogue among health care providers, technologists, and patients
• Transparency and consent: Supporting transparency and determining whether consent is required or feasible
• Regulatory requirements: Keeping up with evolving federal and state requirements related to privacy and other regulatory requirements
• Data Quality: Assessing quality of data after it is generated

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

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

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.

• 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

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?

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

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)

• 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

• What are real-world practical use cases of AI in health care? We begin our presentation with a demonstration of Microsoft Generative AI products useful to attorneys and to health care industry players

• AI use cases raise a host of legal considerations. Our presentation will provide an overview of some key legal considerations, including privacy and security, copyright, data use and ownership, liability, and monitoring bias

• Hearing from the front lines, we’ll discuss practical challenges and considerations implementing AI use cases, including what issues providers face when contracting with AI vendors

• To manage certain legal and practical challenges, companies create internal AI policies. We’ll discuss best practices for preparing company AI policies and real-world examples

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.

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

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?

• 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

Trustworthy AI must be safe, secure, and resilient. As healthcare organizations and other stakeholders grapple with implementing an appropriate AI governance framework, they must consider how best to identify and address safety risks and other harms to patients, clinicians, and the organization. This session will explore:

• How health care delivery organizations are evaluating AI use cases and solutions

• The risks to safety and other harms that can arise from health AI, including to patients, clinicians and other health care workers, and the operations of the health care organization

• The role that patient safety organizations (PSOs) can play in supporting safety in health AI, where we will discuss:

  • The basics of PSOs, including what they are, what they protect, and how providers and other stakeholders can work with PSOs;

  • Emerging legal and regulatory requirements for addressing AI safety, including in the White House Executive Order on AI (October 2023) and other frameworks; and

  • Ways PSOs can support AI safety and how existing PSO and patient safety frameworks can be modernized to address AI’s unique challenges

• How health care delivery organizations can balance safety with innovation when implementing AI, including implementation considerations for today’s evolving AI landscape