Charlie Artz, Ian Donaldson, & Christopher Raphaely

The session will summarize important case law and regulatory developments affecting physicians and institutions. Topics will include Stark and Anti-Kickback decisions enforced through the False Claims Act; important limitations established by U.S. Court of Appeals decisions relating to remuneration and causation under the AKS; incident to rule cases and regulatory changes; physician restrictive covenant case law; No Surprises Act decisions; narcotics enforcement cases; improper access to medical records by social media companies; the U.S. Supreme Court’s decision affecting the ambiguity of billing rules; Evaluation/Management and -25 Modifier enforcement cases; updated medical marijuana guidelines; and other notable developments. 

Does Chat GPT Dream of Electric Sheep?: Legal Implications of Generative AI in Healthcare
Daniel Shay
This session will explore the ways in which generative AI (e.g., ChatGPT) is currently being used in the health care industry.  It will include a brief overview of how generative AI programs function (as distinct from other software), how various aspects of the health care industry, how it may be used in the future, and the legal issues posed by its use.  The session will examine real-world examples of generative AI use, including "horror stories" to illustrate when and how that use may run into legal trouble, and will offer practical advice to attorneys regarding both their clients' and their own potential uses of generative AI.

A Look Back at 2023 – Research Year in Review
Rebecca Schaefer and Doreen Kornrumpf
This session will review research-related regulatory developments and legal updates over the past year, including legislative and rulemaking changes impacting academic health systems, universities, research institutes and others that conduct clinical research. Among the changes we will review are numerous FDA proposed rules and guidance documents affecting clinical trials, NSPM-33 and related developments in research security regulation, proposed revisions to the research misconduct regulations, and OIG and DOJ enforcement action trends. We will also discuss hot topics that implicate these regulatory considerations, and reflect trending transactions and questions frequently asked of research counsel.

Tax Issues for Tax-Exempt Healthcare – A 2023-24 Update
Daniel Hennessey
The session would cover a range of tax issues and developments over 2023 and early 2024 that specifically impact the tax-exempt healthcare industry.  Topics covered would include IRS exempt organization initiatives, regulatory changes and rulings, trends in Section 501(c)(3) compliance and enforcement, tax exemption and community benefit standards for hospitals, tax-exempt M&A and corporate structure topics and developments in state/local tax exemption matters, among other salient issues.

Through the Looking Glass:  A Journey Through Post-Acute Regulation and Enforcement
Paula Sanders
Barely a month goes by without a major news story about quality of care, survey enforcement, and transparency and profits in the post-acute industry, including a December 4, 2023 headline in The New York Times, “Big Profits in Caring for the Elderly,” and a June 22, 2023 article in The Philadelphia Inquirer, “Sen. Bob Casey worries that nursing homes and ‘uninspected and neglected.’”  The session will explore the following: Comprehensive new PA regulations for long term care facilities and the Centers for Medicare and Medicaid Services (CMS) aimed at improving quality of care and increasing transparency; New staffing requirements and increased ownership disclosures which are hallmarks of both agencies’ initiatives; Inconsistencies and challenges created by the regulatory changes affecting staffing, changes of ownership, licensure renewals and revalidation; Heightened enforcement and crippling civil penalties resulting from the new state and federal initiatives.

Practical Tips for the Design of a Patient Safety Evaluation System to Promote Patient Safety and Maximize Privilege Protection for PSWP
Beth Anne Jackson and Angela Boateng
Federal and State law both offer privilege protection to promote the collection, analysis and reporting of patient safety work product to improve quality of care.  This session will offer practical insights to providers and their legal counsel on how to develop and use their patient safety evaluation systems to encourage internal and external sharing of patient safety learnings for the improvement of patient safety and quality without jeopardizing privilege protection.

Health Care Antitrust Update – The Year in Review
Charles Honart
This past year has again been an active one in the health care antitrust world. This year’s course will review recent federal court cases and significant regulatory developments both at the Federal Trade Commission and Department of Justice level including the FTC's proposed major changes in the Hart-Scott-Rodino pre-merger notification requirements and the FTC’s and DOJ's proposed merger guidelines for hospitals along with a review of recent  FTC and DOJ enforcement initiatives.

The No Suprises Act Two Years In: How the Act and Ensuing Litigation are Affecting Patients, Plans and Providers
Kaitlin Rosenthal and Christopher Raphaely
The landmark No Surprises Act established broad federal protections for patients against surprise medical bills and expenses.  We will provide a general overview of the law and then review additional government guidance and litigation updates since its implementation.

Joint Ventures with Operators – Strategy, Development, and Execution
Danielle Bangs and Jonathan Moyer
Increasingly, health systems are partnering with niche operators with focused expertise and success in operating verticals like dialysis, behavioral health, urgent care, ambulatory surgery, imaging and managed care. Health systems enter into these partnerships with the hopes of driving the success of these areas, which may not be core competencies of a traditional health system but are essential for succeeding in the evolving healthcare environment. Partnership with one of these platform operators can improve access and care offerings, drive a stronger bottom line and reduce operational headache for the health system. But partnerships are not easy, and as the partnership is formed and deal terms are defined, it is essential for the health system and the partner to navigate staying aligned with their mission and business objectives, adhering to the specific  regulations and standards driven by their for-profit/not-for profit status and regulatory environment, working through matters of governance and day-to-day control of operations and ensure fair economic terms – all to ultimately ideally arrive at a sustainable partnership that benefits each party. In this presentation, we will leverage the use of specific case studies to cover rationale and trends in these partnerships, key points of negotiation, including governance, operational control, restrictive covenants, term, etc., strategies for navigating concern around “break up” – including in the event of a change of control, financial considerations, and navigating strategic and competitive considerations and alignment.

Brian Alexander
Underlying forces within the American economy and society have led to a crisis for America’s rural and small community hospitals. Hundreds are in danger of closing their doors. This was true before the pandemic and it’s true now. But the pandemic vividly displayed how the social and economic inequity endemic in the United States has led to declining health and longevity for both hospitals and their patients. Americans are faced with two parallel economies, one the “normal” economy, and one the “healthcare economy.” Both are dysfunctional in different ways. The healthcare economy, the largest segment of the American economy, is rapidly consolidating. Wall Street financiers, like private equity funds, are buying up its pieces, from emergency room staffing, to private medical practices. Big hospitals and “health systems” are becoming diversified businesses determined to increase profit margins (even if the hospitals are officially “non-profit”). But all this movement has left deep fractures exposed by the pandemic and increased interest in moving to a national health system. This will be a big part of the political battles to come.