Schedule

• The ever-changing technology landscape: Generative AI in the practice of health law, machine learning, advance/changes in electronically enabled healthcare services
• Economic pressures/financial distress in the US health care sector
• Health Care Employment Law Issues
• Reproductive health care and gender affirming care challenges
• Regulatory guidance in a new, post-Chevron Deference Era
• Health care in underserved communities/health equity disparities and initiatives to address
• Billing Transparency Requirements/Surprises under the No-Surprises Act

Privacy is becoming one of the core areas for understanding in virtually all areas of health law. Privacy affects most health care policy issues, corporate transactions, business contracts, litigation, business strategy and a wide range of overall compliance issues. This session will provide a baseline for all health lawyers on key areas where health privacy law impacts the business of health care and the use of health information across our health care system.

• The difference between Medicare Parts A – D, including how the programs work for beneficiaries and providers/suppliers, and what coverage and reimbursement is available for items/services.
• A discussion of essential terminology (e.g., NPI, provider vs. supplier, enrollment vs. credentialing, conditions of participation vs. conditions of coverage, opt-out vs. non-participating vs. out-of-network, etc.), as well as a brief overview of the CMS-1500 claim form and ADA Claim Form   
• Medicare initial enrollment requirements and continuing reporting obligations for various provider/supplier types
• Medicare Advantage, Prescription Drug Plans, and the role of eligibility, benefit design, provider and pharmacy networks, and financing in Parts C and D
• Hot Topics in Medicare Parts A through D, including the impact of the Inflation Reduction Act of 2022

• An overview of the Medicaid program and its program objectives
• Medicaid financing and governance
• Medicaid fee-for-service and Medicaid managed care
• The common “bones” of Medicaid programs and how they differ
• Fundamental issues in Medicaid (enrollment, credentialing, reimbursement, compliance)
• How to research Medicaid issues

• An introduction to the Physician Self-Referral Law (PSL), including its legislative and regulatory history
• Key terminology of the PSL
• Exceptions to the PSL’s prohibitions and how to use them effectively
• PSL precautions and practitioner tips

• Elements of AKS and EKRA and major cases interpreting them
• AKS Safe Harbors – what they are and how to use them
• Examples of how AKS and EKRA apply to common business arrangements
• How to reduce AKS and EKRA risks
• Significant enforcement and case law trends

• This session aims to contrast the Physician Self-Referral Law and Anti-Kickback Statute from a policy and operational perspective
• Discussion of enforcement and implications of violating either law
• Evaluation of hypothetical arrangements and the analytical framework for determining whether either, both, or neither of the laws are implicated

• Activity that might prompt a government investigation
• Responding to government subpoenas
• Litigating a False Claims Act case
• Best practices for helping clients navigate FCA investigations and litigation

Panelists will discuss their career paths, professional development, and career growth, particularly how mentorship, sponsorship and/or executive coaching has played or continues to play a role in their career as a mentee or mentor, or both. Additionally, each speaker will touch on how each of their organizations approach mentorship, sponsorship and/or executive coaching, whether formally or informally. The session will also highlight AHLA’s Bridges to Law collaboration with CVS Health and AHLA’s mentoring program. Attendees will have an opportunity to breakout and discuss the topic with their table and report out observations, ideas, questions to all in attendance. There will be a Q&A time towards the end of the program for attendees to engage and learn more form session speakers. Topics discussed will touch on and add to, conversations that occurred in a series of educational calls the ECPC and WLC joint hosted in 2023.

Speakers will provide an overview of key drivers of health policy in the United States, including increasing health care costs. They will then dive into the policy development process and how attorneys may impact policy throughout their careers. Speakers will provide case studies of current health policy issues, challenges and considerations facing stakeholders in the health care ecosystem, including hospitals, health systems and physicians.

• The key drivers of health policy in the United States
• Learn the basics of the policy process and key ways in which attorneys can influence policy on behalf of their clients
• Timely health policy issues and considerations currently in play, how they might be addressed through policy development and the impact they have on hospitals, health systems, and physicians

• What is AI?
• Why do we care?
• How will AI affect the practice of law?
• How will AI affect our clients?
  • Discovery and document review
  • Contract analysis and due diligence
• How are health care stakeholders using AI?
• Ethical issues
  • Rules and formal ethics opinions

• Applicable statutes, regulations, and accreditation requirements for hospital medical staffs
• Underlying legal, business, and operational issues for hospital medical staffs
• Emerging issues and areas of emphasis, including:
  • Medical Staff/employed physician considerations
  • Integrating non-physician Advanced Practice Professionals
  • Peer review and Information sharing
  • Evolving role of Medical Staffs on quality
  • Trends in Medical Staff governance and oversight
  • Drafting tips and sample language for hospitals

• Overview of Industry: Understand industry segments (mental health, substance use disorder, intellectual and developmental disability, etc.) and care settings
• Defining Legislation of Last Decade: Review the laws that have shaped the behavioral health landscape in recent years, including the Mental Health Parity and Addiction Equity Act; Comprehensive Addiction and Recovery Act; SUPPORT for Patients and Community Act; and others
• Unique Legal Issues: Gain awareness of laws that specifically impact behavioral health providers, including stringent and overlapping privacy laws; all-payer fraud and abuse laws; and nuanced state involuntary commitment laws
• Hot Legal Topics: Explore current hot-button issues in behavioral health, including Medication-Assisted Treatment for opioid use disorder; tech– and telemedicine-enabled behavioral health; and private equity investment

This presentation will focus upon the core requirements for health care organizations to qualify for tax exemption under Code Section 501(c)(3), including the mandate to be operated for charitable purposes and the prohibitions against private inurement, substantial lobbying, and political campaigning. The discussion also will cover such related issues as:

• Distinguishing between public charities and private foundations
• Preventing improper benefits to third parties
• Applying the rules governing unrelated business income tax
• Helping hospitals comply with their obligations under Code Section 501(r)
• Understanding the increasing scrutiny of hospitals and health care organizations from Congress, the IRS, the media, and others

• Applicable statutes, regulations, and accreditation requirements for hospital medical staffs
• Underlying legal, business, and operational issues for hospital medical staffs
• Emerging issues and areas of emphasis, including:
  • Medical Staff/employed physician considerations
  • Integrating non-physician Advanced Practice Professionals
  • Peer review and Information sharing
  • Evolving role of Medical Staffs on quality
  • Trends in Medical Staff governance and oversight
  • Drafting tips and sample language for hospitals

This session will explore the regulatory framework governing the U.S. commercial health insurance market and managed care contracting arrangements

• Defining key concepts to understand commercial health insurance
• Breaking down major regulators, stakeholders, and components of the U.S. commercial health insurance market
• Surveying the primary state and federal laws regulating health insurance and other health care risk arrangements
• Explaining managed care and the elements of managed care contracting

• Physician Employment
  • Current environment
  • Employee Contracting–Top 10 issues (Physician and Employer Perspective)
• Physician Employment–Fraud and abuse legal considerations
  • The Anti-Kickback Statute
  • The Stark Law
    • Employment exception
    • Group practice definition
• The Corporate Practice of Medicine

• Overview of telehealth, digital health, and AI in health care
• Telehealth, digital health, and AI industry regulators, applicable laws and guidance
• Structures and models
• Legal risk areas for telehealth and digital health, including privacy, corporate practice of medicine, fraud and abuse, and FDA regulation of medical devices
• Legal risk areas and considerations for AI
• Enforcement actions and trends (e.g., special fraud alerts, litigation involving AI algorithms and medical necessity determinations or healthcare staffing determinations)

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

• Different types of transaction structures for a health care deal (e.g., asset purchase versus stock purchase or merger)
• A working framework for in-house and outside counsel teamwork, including on approaching due diligence in a health care transaction
• Regulatory and legal issues common to health care transactions (e.g., federal Anti-Kickback and Stark Laws; antitrust issues; and tax-exempt issues)
• The importance of the concepts of “fair market value” and “commercial reasonableness” to a health care transaction
• Apply these strategies to a case study (physician-hospital integration), sample letter of intent, and sample due diligence checklist to understand how various factual scenarios could affect the transaction and to highlight diligence and transactional considerations

• Introduction to post-acute provider types (both facility-based and home-based)
• Reimbursement for post-acute care, including an overview of Parts A-D of the Medicare program as they related to post-acute providers, and Medicaid reimbursement
• State licensing and survey process for post-acute providers
• Medicaid Waiver programs for home-based care and PACE programs

Panelists including both former and current Federal Trade Commission staff and managers from Mergers I and Mergers IV division, in-house counsel, and private practitioner active in health care M&A antitrust, will discuss antitrust considerations in the context of health care merger review and collaborations, including:

• Background on the applicable antitrust laws and substantive framework
• Federal and state enforcement agency trends such as revised merger guidelines, recent enforcement actions, and emerging state notification requirements
• Key practical considerations when counseling on health care transactions or collaborations

• Compliance Program design and implementation considerations
• The Government's focus on Compliance Program effectiveness
• The Board's role in compliance
• Distinguishing the role of Legal and Compliance in compliance matters

Though professional licensure is inherently a state law issue, there are a number of concepts that apply broadly across the states. Attendees will hear from in-house and outside counsel on the following topics (among others):

• Background on state regulation of medical professionals
• Instructions on performing scope of practice analyses, and compliance considerations related to same
• Tips for handling disciplinary matters involving state licensure boards
• Advice on analyzing scenarios that involve prescribing across state lines

The presenters will share common and interesting real-life scenarios to demonstrate how these topics present in everyday practice, and enhance attendee comprehension.

• Physician Employment
  • Current environment
  • Employee Contracting–Top 10 issues (Physician and Employer Perspective)
• Physician Employment–Fraud and abuse legal considerations
  • The Anti-Kickback Statute
  • The Stark Law
    • Employment exception
    • Group practice definition
• The Corporate Practice of Medicine

• Overview of telehealth, digital health, and AI in health care
• Telehealth, digital health, and AI industry regulators, applicable laws and guidance
• Structures and models
• Legal risk areas for telehealth and digital health, including privacy, corporate practice of medicine, fraud and abuse, and FDA regulation of medical devices
• Legal risk areas and considerations for AI
• Enforcement actions and trends (e.g., special fraud alerts, litigation involving AI algorithms and medical necessity determinations or healthcare staffing determinations)

• What is AI?
• Why do we care?
• How will AI affect the practice of law?
• How will AI affect our clients?
  • Discovery and document review
  • Contract analysis and due diligence
• How are health care stakeholders using AI?
• Ethical issues
  • Rules and formal ethics opinions

Panelists including both former and current Federal Trade Commission staff and managers from Mergers I and Mergers IV division, in-house counsel, and private practitioner active in health care M&A antitrust, will discuss antitrust considerations in the context of health care merger review and collaborations, including:

• Background on the applicable antitrust laws and substantive framework
• Federal and state enforcement agency trends such as revised merger guidelines, recent enforcement actions, and emerging state notification requirements
• Key practical considerations when counseling on health care transactions or collaborations

• Compliance Program design and implementation considerations
• The Government's focus on Compliance Program effectiveness
• The Board's role in compliance
• Distinguishing the role of Legal and Compliance in compliance matters