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Advising Providers: Legal Strategies for AMCs, Physicians, and Hospitals

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. 

Shaded sessions are specifically designed for the academic medical centers and teaching hospitals audience.

Monday
Schedule

 

Tuesday
Schedule

 

Wednesday
Schedule

         

Monday, February 5, 2024

7:00 am-5:00 pm

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

 
7:00-8:00 am

Continental Breakfast, sponsored by PYA
This event is included in the program registration. Attendees, speakers, and registered guests are welcome.

 
8:00-11:15 am General Session

8:00-8:15 am
Welcome and Introduction
Patricia Markus, AHLA President


8:15-9:30 am
1. The Digital Revolution in Health Care: Accelerating Demands to Rebalance Risk vs. Opportunity
Christine Moundas, Ropes & Gray LLP, New York, NY (Moderator)
Lee H. Schwamm, SVP + Chief Digital Health Officer, Yale New Haven Health System, Associate Dean, Digital Strategy and Transformation, Professor, Biomedical Informatics and Data Sciences Clinical Faculty, Vascular Neurology Division, Dept of Neurology Yale School of Medicine, New Haven, CT
Tina R. Tyson, Deputy General Counsel for Health Affairs, Office of the Sr. Vice President and General Counsel, Yale University, New Haven, CT

More Information

Innovative technologies including Artificial Intelligence (AI) present significant opportunities for efficiencies and time savings in clinical care but also pose risks for quality assurance and data integrity.  This session will discuss:

  • Some significant potential technology advances and how risks, while not eliminated, can be mitigated

  • Institutional approaches to address data privacy concerns as balanced against benefits from increased use of data assets

  • Themes in contracting related to innovative technologies and use of data and issues that should be considered to minimize risks

  • A governance construct for joint university and affiliated health system decision making with regard to innovative uses of data outside of research that surface emergent or novel risks. This model is specific to the context of a university and affiliated health system, which are two separate legal entities without ownership interests in the affiliated entity


9:30-9:45 am
Break


9:45-11:15 am
2. Year in Review
S. Craig Holden, Baker Donelson Bearman Caldwell & Berkowitz PC, Baltimore, MD  
Robert G. Homchick, Davis Wright Tremaine LLP, Seattle, WA    
Cynthia F. Wisner, Trinity Health,  Livonia, MI

More Information

  • Health Equity and Access 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

  • Telemedicine updates and impact of expiration of state license waivers

  • Health Care Transactions (from hot trends, to record number of bankruptcies, to private equity, to tax issues, to new antitrust theories)

  • Hot HIT developments (artificial intelligence, cyber-attacks, information blocking and interoperability, OCR enforcement, and state laws)

  • Price transparency enforcement and drug prices litigation

  • Reimbursement trends and 340B

  • And much more!

 
11:15-11:45 am

Coffee and Networking Break
Exhibits Open–Meet the Exhibitors

 
11:45 am-12:45 pm

3. Recent Updates in GME Policy (not repeated)
Allison Cohen, Baker Donelson Bearman Caldwell & Berkowitz PC, Washington, DC
Bradley Cunningham, Senior Policy and Regulatory Analyst, Association of American Medical Colleges, Washington, DC

More Information

Over the last several years, legislative and regulatory changes have significantly updated certain Medicare graduate medical education (GME) payment policies. This session will provide a basic overview of Medicare GME and discuss the following key policy changes that impact academic health systems.

The Consolidated Appropriations Act (CAA) 2021 provided 1,000 new Medicare-funded GME slots, fundamentally changed the Rural Track Program (RTP), and provided a window for certain hospitals to reset very low or zero Per Resident Amounts (PRAs) or GME caps. The Consolidated Appropriations Act 2023 approved an additional 200 Medicare-funded GME slots that will be distributed based on some overlapping and some differing criteria as the CAA 2021. In 2022, the Centers for Medicare & Medicaid Services (CMS) implemented a regulatory fix to the “fellows’ penalty” in response to the court’s holding in Milton S. Hershey Med. Ctr. v. Becerra, 19-cv-3763 (D.D.C. May. 17, 2021). CMS’s regulatory change spurred by the Hershey decision created a new DGME payment methodology to eliminate a penalty that affected hospitals training over their caps that also train fellows. As of FY 2023, the CMS will for the first time allow hospitals participating in certain RTPs to enter GME affiliation agreements. In the FY 2024 Inpatient Prospective Payment System final rule, CMS finalized a policy allowing Rural Emergency Hospitals (REHs) (a new hospital designation) to participate in Medicare GME by receiving reimbursement directly or as a non-provider site.


4. Real Life Lessons in Value-Based Care: Advanced Perspectives (not repeated)
Samuel Bernstein, McGuireWoods LLP, Chicago, IL
Alexandra DuPuis, Deputy General Counsel, Evergreen Nephrology, Atlanta, GA
Jennifer Guckert Griffin, Interim Chief Legal Officer, Corporate Secretary, Amedisys, Inc., Nashville, TN
Elizabeth R. Hammack, Deputy General Counsel, University Hospitals, Shaker Heights, OH


5. Research Misconduct Regulations
Kate G. Heffernan, Epstein Becker & Green PC, Boston, MA
Elizabeth J. McEvoy, Hinckley Allen, Boston, MA

More Information

This session will address emerging trends in research integrity and misconduct proceedings. Specifically the session will cover the following:

  • Introduction/overview: Research Integrity and Misconduct Today

    • Basic introduction to level-set (e.g., review the regulatory definition of research misconduct; identify the institutional/federal players involved)

    • How the initiation of a research misconduct complaint has changed from traditional whistleblower complaints (i.e., the increasing involvement of PubPeer, Artificial Intelligence technology and on-line integrity vigilantes in identifying potential concerns, and ORI’s direct involvement/delegation to institutions to inquire into these matters)

    • How the trajectory of a research misconduct proceeding has changed (i.e., ORI’s “scope” guidance)

  • Recent Trends and Enforcement Activity (e.g., the intersection of research misconduct and the False Claims Act/Civil Monetary Penalties)

    • Duke to Purdue (https://www.justice.gov/usao-ndin/pr/settlement-purdue-university-false-claims-research-grant-applications-federal-agencies), and settlements in between (e.g., Van Andel Research Institute) 

  • Where Are We Going: The Proposed PHS Rule (key proposed changes will be discussed from the perspective of a respondent vs. an institution conducting the proceedings)

    • 6-year time limitation and requirements around subsequent use exception

    • New definitions (e.g., recklessly, honest error)

    • Confidentiality

    • Procedural changes (e.g., formalized assessment, requirements for elective procedural rights, etc.)


6. Private Equity - Be Careful, It Ain't Private Anymore
John E. Kelly, Barnes & Thornburg, Washington, DC
Kim H. Looney, K & L Gates LLP, Nashville, TN

More Information

  • Is the expansion of the role of Private Equity in the health care industry a positive or a negative?

    • Pros

    • Cons

  • Why is the government focusing on PE investments in health care?

  • What factors increase the risk of government scrutiny of PE role in health care enterprise?

  • What types of actions/investments by PE are likely to garner media attention?

  • Antitrust scrutiny of PE investments in health care

 
12:45-2:15 pm

Networking and Presentation Lunch, sponsored by VMG Health

Title: Union Organizing in Academic Medical Centers
Trecia Moore, Husch Blackwell LLP, Kansas City, MO

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.

More Information

Academic medical centers are facing a growing interest in unionization among residents and trainees. What’s driving this and what can institutions do to address this trend? Join Trecia Moore to analyze the trend and provide tips to address and protect against potential unionization.

 

2:30-3:30 pm

7. Redefining the Physician Enterprise for Value-Based Care (Advanced) (not repeated)
James M. Daniel, Hancock Daniel, Glen Allen, VA
Daniel W. Peters, Senior Vice President & General Counsel, The University of Kansas Health System, Kansas City, KS

More Information

This session will explore how financial pressures and changing market dynamics are forcing players in healthcare to rethink the physician enterprise in order to be competitive in new economic and strategic climates. The growing momentum for value-based care and the impact of complex payor negotiations is driving hospitals and physicians towards varying degrees of collaboration and integration. This presentation will highlight provider alignment models, and examine how academic medical centers, community hospitals and physicians can work together to remain competitive, meet financial objectives, and position themselves in light of new market disruptors.  The program will also focus on how value-based payment models and new technologies are redefining the traditional physician enterprise.


8. Expansion without Acquisition: Health System Affiliation Strategies for Expanding Impact, Reach, and Revenues
Michael B. Lampert, Ropes & Gray LLP, Boston, MA
Eleni Robertson, Assistant General Counsel, Memorial Sloan Kettering Cancer Center, New York, NY

More Information

  • What factors are driving academic health systems to expand?

  • What challenges to academic health systems encounter in expanding through traditional acquisition?

  • What strategies can academic health systems consider to expand without actually acquiring their new constituent members?

  • How might academic health systems evaluate the options for themselves?


9. Drug Pricing and Reimbursement Current Opportunities and Challenges
Micah C. Burns, Division Counsel, Vanderbilt University Medical Center, Nashville, TN
Andrew D. Ruskin, K&L Gates Washington, DC

More Information

  • An illustrated discussion of the drug distribution chain and the hospital’s role therein

  • The Medicare program’s implementation of drug reimbursement reductions resulting from the Inflation Reduction Act

  • Update on the resolution of the Supreme Court decision reversing CMS 340B underpayments, both with respect to Medicare fee for service, as well as strategies for dealing with MA plans

  • State and Federal legislation and litigation affecting 340B utilization

  • Considerations for health systems as employers seeking to control their own drug spends


10. Medical Staff Policies and Their Risks
Alexis L. Angell, Polsinelli PC, Dallas, TX
Lindsey P. Ridgway, VP, Deputy General Counsel, Integris Health, Oklahoma City, OK
Scott Nichols, Nichols Brar Weitzner & Thomas, Houston, TX

More Information

This session will bring differing perspectives from in-house counsel for the health care entity, outside counsel for the medical staff, and counsel for the physician under peer review to provide the audience with insights through interactive discussion of hypotheticals touching on the following topics:

  • How to approach and work with physicians and medical staffs when wellness or health issues arise due to new or increased complaints, expressed concerns from colleagues, or trending data showing the need for a potential slow down of practice

  • Best practices for the hospital, medical staff, and physician when participating in collegial interventions and investigations and discussion of the NPDB’s updated guidance regarding when an investigation begins and reporting requirements for resignation while under or to avoid investigation

  • Options for avoiding the fair hearing process, including strong medical staff bylaws language and using experienced counsel to come to a reasonable resolution

  • Key items to know when the fair hearing is unavoidable to promote a fair and efficient process for the physician and the medical staff

 
3:30-4:00 pm

Coffee and Networking Break
Exhibits Open–Meet the Exhibitors

 
4:00-5:00 pm

11. Systemness: Getting Beyond the Culture Clash of Faculty and Community Physicians (Advanced) (not repeated)
Rudd Kierstead, Director, Veralon Partners Inc., Bala Cynwyd, PA
Megan S. Mueller, Associate General Counsel, Thomas Jefferson University and Jefferson Health Office of Legal Affairs, Philadelphia, PA

More Information

Questions about physician enterprise performance are surfacing with greater urgency. In the academic medical center (“AMC”) and academic health system (“AHS”) settings, these issues are complicated by the need for academic physician organizations and the community physician entities to work together, and for employed faculty and community-based physicians to achieve a common mission and goals. This need comes from a desire to realize “systemness” and improve tripartite programming, align governance and operations, standardize clinical care and quality, rationalize compensation, and facilitate funds flows. This session will result in approaches to address structural, governance, regulatory and business considerations toward achieving “systemness” by:

  • Identifying and addressing common needs for faculty & community physicians while protecting, if not facilitating, their differing focus in the AMC/AHS setting, whether research, teaching, or clinical care delivery

  • Maintaining structures and processes that promote the effective delivery of services for patients, trainees, and system hospitals and college

  • Developing value-based care by building on the distinct, yet complementary, roles of faculty and community physicians (both employed and independent)

  • Managing the impact of AMC/AHS consolidations on faculty and community physician dynamics


12. Break-ups, Terminations, and Containing Healthcare Litigation Costs (not repeated) (Advanced)
Daniela Almeida, Deputy General Counsel, Sutter Health, Sacramento, CA
Heather Candy, Vice President & Associate General Counsel, Adventist Health, Roseville, CA
Leslie C. Murphy, Davis Wright Tremaine LLP, San Francisco, CA

More Information

  • Recent trends in health care contracting, including payer-provider, employees, vendors, and more 

  • Effective contracting and litigation strategies to help reduce litigation costs, including terms to streamline the dispute resolution process

  • High-risk areas of litigation for hospitals and medical groups

  • The litigation management tools and strategies used by in-house attorneys to control costs


13. Digital Health and Artificial Intelligence
Vanessa K. Burrows, Simpson Thacher & Bartlett LLP, Simpson Thacher & Bartlett LLP
Carolyn V. Metnick, Sheppard Mullin Richter & Hampton LLP, Chicago, IL

More Information

  • Digital health and AI industry regulators and applicable laws

  • AI in health care–what’s going on and where is regulation of AI headed? 

    • President Biden’s Executive Order and the role of HHS

    • ONC’s finalization of rule to increase algorithm transparency

  • Legal risk areas for digital health and AI, including privacy, corporate practice of medicine, fraud and abuse, and FDA regulation of medical devices

  • Recent developments in digital health and AI, including enforcement actions and regulatory guidance 

    • HHS OIG Special Fraud Alert on Telehealth

    • FTC actions regarding AI

    • FDA actions regarding AI


14. Structuring Physician/Hospital Arrangements–Stark Law/AKS Considerations in Today’s Enforcement Climate
Donna S. Clark, Norton Rose Fulbright, Houston, TX
Robert McStay, Chief Compliance Officer, Senior Vice-President, Memorial Hermann Health System, Houston, TX

More Information

This session will discuss Stark/AKS issues that arise in hospital/physician arrangements. In particular, we will address:

  • Employment and Professional Service Agreements (including common compensation models and warnings provided by recent settlements)

  • Transfer of funds between components of an AMC and the indirect compensation analysis under the Stark Law

  • Joint ventures involving hospitals and physicians

  • Physician recruitment agreements

 
5:00-6:00 pm

Networking Reception, sponsored by PYA
This event is included in the program registration. Attendees, speakers, and registered spouses and guests welcome.

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Tuesday, February 6, 2024

7:00 am-4:30 pm

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

 
7:00-8:00 am

Continental Breakfast, sponsored by PYA
This event is included in the program registration. Attendees, speakers, and registered spouses and guests welcome.

 
7:30-9:30 am

15. In-House Counsel Think Tank, sponsored by HealthCare Appraisers, Inc
Allison Petersen, General Counsel, Integris Health, Oklahoma City, OK (Moderator)

This event is for attendees who serve as the general counsel or an in-house counsel at a health care provider ONLY; pre-registration is required; limited attendance (100); there is no additional fee.

 
8:00-9:15 am 

16. An Ounce of Prevention: Strategies to Address Inappropriate Provider Conduct at your AMC before it Becomes a Black Swan Event (not repeated)
Stacy Bratcher, Senior Vice President and Chief Legal Officer, Cottage Health, Santa Barbara, CA
Andreas Meyer, AJM Firm, Wichita, KS
Tom Ryan, McDermott, Will & Emery, Los Angeles, CA
Jeannine Taylor, Deputy General Counsel, Keck Medicine of USC, Los Angeles, CA

More Information

  • AMCs and universities have paid more than $3 billion to resolve sexual assault and harassment claims arising from "sensitive exams" performed by employed physicians; making care environments safe is a "mission critical" risk for AMCs and their board to manage

  • Key steps for responding to a risk event at your AMC, including interactions with regulatory agencies, managing litigation, criminal proceedings, insurance recovery and public relations aspects

  • How Title IX, the Clery Act and ACA Section 1557 apply to Academic Medical Centers and how you can comply

  • How an effective risk management program and peer review structure can help identify risk issues and help you avoid black swan events


17. Current Trends in Payer/Provider Disputes​
Elise D. Brennan, Conner & Winters LLP Tulsa, OK
Mackenzie S. Wallace, Thompson Coburn, Dallas, TX
Jeff J. Wurzburg, Norton Rose Fulbright, San Antonio, TX

More Information

  • Trends, practices, and tips across roles in disputes between physicians/health systems and payers, particularly in navigating the provider/hospital services agreements

  • Highlighted opportunities for improved positioning from multiple perspectives—provider, payer, arbitrator, and expert—when resolving such disputes

  • How to (1) anticipate such disputes, (2) establish robust processes for evidence preparation for such disputes, and (3) efficiently navigate such disputes

  • Typical contractual clauses in dispute and explore the stages of the disputes

  • The presentation is aimed to equip the audience with a comprehensive understanding of how to navigate and strategically approach provider/payer disputes in the current landscape


18. Antitrust Enforcement in the Biden Administration: What Health Care Counsel Needs to Know
Holden Brooks, McGuire Woods, Chicago, IL
Karen Hunt, Deputy Assistant Director for Mergers IV, Federal Trade Commission, Washington, DC
Joseph Miller, Mintz Levin Cohn Ferris Glovsky & Popeo PC, Washington, DC

More Information

  • Merger policy – what’s new and what’s not for health care providers

  • Withdrawal of the Health Care Guidelines

  • Proposed rule on non-compete agreements in employment contracts

  • Private equity – why the hostility?

  • Increasing state AG interest in provider mergers

  • And much more

 
9:15-9:45 am

Networking Break
Exhibits Open–Meet the Exhibitors

 
9:45-10:45 am 

19. Navigating Hospital-Based Coverage: Practice Consolidation, Compensation, and Negotiation (not repeated)
Ryan Kirshenbaum, J.D., Lead Staff Attorney - Nebraska Methodist Health System, Adjunct Professor of Law, Creighton University School of Law, Omaha, NE
Andrew Worthington, HealthCare Appraisers, Inc, Dallas, TX

More Information

  • Hospitals and corporations continue to acquire medical practices. These acquisitions were further accelerated due to COVID-19

  • As a result, securing affordable and efficient hospital-based clinical coverage is even more challenging

  • Financial support for and the costs to employ hospital-based coverage is a material expense for any health system

  • We will share our experience and solutions when it comes to contracting with medical groups for this coverage and in employing physicians and APPs for these service lines

  • Specifically, navigating pitfalls and challenges with regards to high staffing costs for physicians and APPs, rising profit margins and management fees, survey lag, volume and utilization

  • Securing a cost-effective, compliant coverage does not have to be a daunting task


20. Advancing Diversity in Academic Medicine After the Harvard/UNC Cases
Margia K. Corner, Senior Principal Counsel, University of California Office of General Counsel, Oakland, CA
Tahvia Jenkins, Athene Law, San Francisco, CA
Frank Trinity, Chief Legal Officer, AAMC, Washington, DC

More Information

Advancing diversity in the health care workforce remains critical to promoting health equity, improving patient experience, and improving patient safety.  These efforts are integral to the mission of academic medical centers.  The Supreme Court's decision in the Harvard and UNC cases poses new obstacles to racial diversity strategies in medical and other health professions schools.  But there are many public institutions, such as the University of California, that have several decades' worth of experience pursuing race-neutral diversity strategies.  This session is intended to facilitate a conversation about strategies that remain permissible after the Harvard/UNC decision and under state Constitutions/laws that prohibit preferential treatment based on race.  We will also address strategies that appear to vulnerable to future challenges and/or that may not survive scrutiny under these laws.


8. Expansion without Acquisition: Health System Affiliation Strategies for Expanding Impact, Reach, and Revenues (repeat)
Michael B. Lampert, Ropes & Gray LLP, Boston, MA
Eleni Robertson, Assistant General Counsel, Memorial Sloan Kettering Cancer Center, New York, NY

More Information

  • What factors are driving academic health systems to expand?

  • What challenges to academic health systems encounter in expanding through traditional acquisition?

  • What strategies can academic health systems consider to expand without actually acquiring their new constituent members?

  • How might academic health systems evaluate the options for themselves?


10. Medical Staff Policies and Their Risks (repeat)
Alexis L. Angell, Polsinelli PC, Dallas, TX
Lindsey P. Ridgway, VP, Deputy General Counsel, Integris Health, Oklahoma City, OK
Scott Nichols, Nichols Brar Weitzner & Thomas, Houston, TX

More Information

This session will bring differing perspectives from in-house counsel for the health care entity, outside counsel for the medical staff, and counsel for the physician under peer review to provide the audience with insights through interactive discussion of hypotheticals touching on the following topics:

  • How to approach and work with physicians and medical staffs when wellness or health issues arise due to new or increased complaints, expressed concerns from colleagues, or trending data showing the need for a potential slow down of practice

  • Best practices for the hospital, medical staff, and physician when participating in collegial interventions and investigations and discussion of the NPDB’s updated guidance regarding when an investigation begins and reporting requirements for resignation while under or to avoid investigation

  • Options for avoiding the fair hearing process, including strong medical staff bylaws language and using experienced counsel to come to a reasonable resolution

  • Key items to know when the fair hearing is unavoidable to promote a fair and efficient process for the physician and the medical staff

 
10:45-11:00 am

Break

 
11:00 am-12:00 pm

21. Unreasonable and Overreaching or Justified? UPIC and Contractor Audits, Payment Suspensions, and Finding Resolution (not repeated)
Aletheia Lawry, Fountain Hills, AZ
B. Scott McBride, Morgan Lewis & Bockius Houston, TX

More Information

  • Review of UPIC activity

  • What is the scope of the UPIC?

  • Can the UPIC really ask for all that information?

  • How do you deal with a payment suspension?

  • What happens after the UPIC audit?


22. Legal Ethics Smooth Jazz - The Harmony Trio: Board Chair, President (CEO), and Legal Counsel
Sandra M. DiVarco, McDermott Will & Emery LLP, Chicago, IL
Lisa Vandecaveye, Chief Legal Officer, The Joint Commission, Oakbrook Terrace, IL

More Information

  • Legal counsel support of governance and management – Who is the client? What rules apply?

  • Providing governance and management legal support in between meetings

  • Board and individual Board member duties – Accreditation and legal standards

  • Maintaining privilege and sharing information with management and governance

  • D&O coverage and immunity – Limitations and practical considerations


23. A Slice of the AMC Pie–Legal and Value Considerations around Service Line Carveouts
Annapoorani Bhat, PYA, Charlotte, NC
Jeanna Palmer Gunville, Polsinelli PC, Chicago, IL

More Information

AMCs tend to be front runners when it comes to investing in important services for the community. Such investments may result in the development of new, innovative care protocols or new and profitable service lines, or they may end up creating substantial drain on scarce resources due to unforeseen circumstances or changing economy/industry trends. In some instances, it may be determined that these ventures will benefit financially and operationally from partnerships with, or a sale to, other health systems or private companies. Housed within the AMC’s legal structure, and dependent on overhead support from the system at large, it can be tricky to evaluate the profitability of these services, and bifurcate them from the overall AMC operations in preparation of a carve-out transaction. This session, which includes case studies, covers how AMCs and their advisors can prepare the organization for successful service line carveout transactions.


13. Digital Health and Artificial Intelligence (repeat)
Vanessa K. Burrows, Simpson Thacher & Bartlett LLP, Simpson Thacher & Bartlett LLP
Carolyn V. Metnick, Sheppard Mullin Richter & Hampton LLP, Chicago, IL

More Information

  • Digital health and AI industry regulators and applicable laws

  • AI in health care–what’s going on and where is regulation of AI headed? 

    • President Biden’s Executive Order and the role of HHS

    • ONC’s finalization of rule to increase algorithm transparency

  • Legal risk areas for digital health and AI, including privacy, corporate practice of medicine, fraud and abuse, and FDA regulation of medical devices

  • Recent developments in digital health and AI, including enforcement actions and regulatory guidance 

    • HHS OIG Special Fraud Alert on Telehealth

    • FTC actions regarding AI

    • FDA actions regarding AI

 
12:00-1:30 pm 

Networking and Presentation Lunch, hosted by Women's Leadership Council, sponsored by Dorsey & Whitney LLP
Title: Advising Providers on Maternal Health Disparities: Challenges and Opportunities

Catherine Lynn Allison, Assistant General Counsel, Office of Legal Counsel, University of Kentucky, Lexington, KY
Priya J. Bathija, Founder & CEO, Nyoo Health, Falls Church, VA
Jennifer M. Nelson Carney, Epstein Becker & Green PC, Columbus, OH
Michael J. Regier, General Counsel and Secretary, Vanderbilt University Medical Center, Nashville, TN

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.

 
1:45-3:00 pm

24. There’s No Place Like Home: Remote Patient Monitoring to Help Dorothy Stay in Kansas while Avoiding the Twister of Regulatory Risks and Bringing Technicolor to the Possibilities of RPM and RTM (Advanced) (not repeated)
Betsy Hodge, Akerman LLP, West Palm Beach, FL
Gerard M. Nussbaum, Zarach Associates LLC Chicago, IL
Sean Sullivan, Alston & Bird LLP Atlanta, GA

More Information

This session will discuss the promises of Remote Physiological Monitoring (RPM) and Remote Therapeutic Monitoring (RTM) while explaining the regulatory and reimbursement rules approaches to overcome operational challenges, and contractual relationships with remote care delivery partners, including:

  • RPM and RTM CPT codes and reimbursement rules, including a summary of current rules and the most recent changes in the 2024 Physician Fee Schedule final rule

  • Use and reimbursement of telehealth when providing RPM and RTM

  • Partnering with third parties, including fraud and abuse implications, supervision issues,  referral partners relationships, and contractual issues

  • Use of technology in RPM and RTM, including vetting technology providers, types of devices, availability and access to broadband, and privacy & security considerations

  • Use of RPM and RTM to address health equity goals and health care disparity, especially in rural areas,  and addressing low technology literacy

  • Operational considerations in implementing and operating RPM/RTM, including data flows and integration challenges

  • The intersection of RPM and RTM with broader patient care management services and in-person care

  • Mitigating risks related to use of RPM and RTM, including documentation and overutilization concerns


25. Integrated Care Models that Address Complex Discharges Found in Academic Medical Centers (not repeated) (Advanced)
Mark A. Johnson, Hooper Lundy & Bookman PC, San Diego, CA
Mary T. Link, System VP/ Deputy General Counsel / Legal Operations, Risk & Regulatory, Middleton, WI
Rebecca Rodman, Husch Blackwell, Boston, MA

More Information

This panel will focus on addressing the challenges to discharging patients from academic medical centers and best practices from the field. Hear from representatives of an Academic Medical Center (AMC) and a post-acute care facility about their experiences with barriers to discharge, how those barriers impact care within the AMC, and how to relieve the subsequent strain on hospitals. The discussion will highlight the following topics:

  • Barriers to discharge

    • Components of a playbook for complex discharges

    • Regulatory and payment barriers

    • Prior authorization, guardianships, payment models issues, and others

  • Opportunities for success

    • The Massachusetts Dialysis Den demo

    • Training models to improve care

    • Creative methods to leveraging staff and financial support

    • Enhancing use of telehealth in the nursing home setting

    • Identifying and building your best partners


26. Managing 2024's Top Compliance Risks and Opportunities (Advanced)
Anthony J. Burba, Barnes & Thornburg, Chicago, IL
Henry C. Leventis, United States Attorney, Nashville, TN
Ted Lotchin, Chief Compliance Officer, UNC Health, Chapel Hill, NC

More Information

This panel will present different perspectives on new and developing compliance risks and opportunities from the US Attorney for the Middle District of Tennessee, a former federal prosecutor specializing in defending organizations from allegations of fraud and abuse, and the chief compliance officer from an academic medical center and teaching hospital. The panel will cover topics including:

  • Government enforcement and audit priorities for the provider community in 2024

  • A review of recent enforcement actions involving academic medical centers, teaching hospitals, and physicians

  • New and evolving risks and benefits of AI and other clinical decision support tools

  • Recent developments in compliance challenges with physician relationships

  • Evaluating your organization's COVID enforcement risk

  • Addressing and mitigating information privacy and security threats


17. Current Trends in Payer/Provider Disputes​ (repeat)
Elise D. Brennan, Conner & Winters LLP Tulsa, OK
Mackenzie S. Wallace, Thompson Coburn, Dallas, TX
​Jeff J. Wurzburg, Norton Rose Fulbright, San Antonio, TX

More Information

  • Trends, practices, and tips across roles in disputes between physicians/health systems and payers, particularly in navigating the provider/hospital services agreements

  • Highlighted opportunities for improved positioning from multiple perspectives—provider, payer, arbitrator, and expert—when resolving such disputes

  • How to (1) anticipate such disputes, (2) establish robust processes for evidence preparation for such disputes, and (3) efficiently navigate such disputes

  • Typical contractual clauses in dispute and explore the stages of the disputes

  • The presentation is aimed to equip the audience with a comprehensive understanding of how to navigate and strategically approach provider/payer disputes in the current landscape

 
3:00-3:30 pm

Networking Break
Exhibits Open–Meet the Exhibitors

 
3:30-4:30 pm

27. Providers and Technology How Much Risk Do You Have: The Good, the Bad, the Ugly, and the Uglier (not repeated)
Marti Arvin, SVP, Chief Compliance and Privacy Officer, Erlanger Health, Ooltewah, TN
Joseph A. Dickinson, Wilmington, NC

More Information

  • The use of technology beyond the EHR

  • The value add of applications-including creating more efficiency and streamlining

  • Providers agreeing to terms with a third parties that allow for sharing of information

  • Whose legal obligation is it when the organization’s data gets shared inappropriately?

  • The organization’s practical responsibilities even if a legal obligation does not exist?

  • Practical ways to raise the awareness of providers


28. Building Compliant Virtual Care Networks: Beyond Bricks and Mortar Into Innovation
Mark S. Kopson, Plunkett Cooney, Bloomfield Hills, MI
Sarah E. Swank, General Counsel, On Belay Health Solutions, Washington, DC

More Information

Health care now is furnished not only in the provider’s office, but also in homes, offices, and other settings. Providers often are in different locations than their patients providing both in-person care and virtual care. In this intermediate-level session, the presenters will cover:

  • An overview of the key features of virtual provider networks (VPNs) and real-life examples of nursing, telehealth and ACO VPNs

  • How VPNs are impacting care delivery, payer-provider relations, network adequacy, and contracting

  • Development and implementation of a legally compliant structure and operations

  • Some of the most common and complex issues VPNs present, including corporate practice of medicine, licensing, supervision rules, and cyber issues

  • Practice pointers and practical solutions for professionals working with VPNs


5. Research Misconduct Regulations (repeat)
Kate G. Heffernan, Epstein Becker & Green PC, Boston, MA
Elizabeth J. McEvoy, Hinckley Allen, Boston, MA

More Information

This session will address emerging trends in research integrity and misconduct proceedings. Specifically the session will cover the following:

  • Introduction/overview: Research Integrity and Misconduct Today

    • Basic introduction to level-set (e.g., review the regulatory definition of research misconduct; identify the institutional/federal players involved)

    • How the initiation of a research misconduct complaint has changed from traditional whistleblower complaints (i.e., the increasing involvement of PubPeer, Artificial Intelligence technology and on-line integrity vigilantes in identifying potential concerns, and ORI’s direct involvement/delegation to institutions to inquire into these matters)

    • How the trajectory of a research misconduct proceeding has changed (i.e., ORI’s “scope” guidance)

  • Recent Trends and Enforcement Activity (e.g., the intersection of research misconduct and the False Claims Act/Civil Monetary Penalties)

    • Duke to Purdue (https://www.justice.gov/usao-ndin/pr/settlement-purdue-university-false-claims-research-grant-applications-federal-agencies), and settlements in between (e.g., Van Andel Research Institute) 

  • Where Are We Going: The Proposed PHS Rule (key proposed changes will be discussed from the perspective of a respondent vs. an institution conducting the proceedings)

    • 6-year time limitation and requirements around subsequent use exception

    • New definitions (e.g., recklessly, honest error)

    • Confidentiality

    • Procedural changes (e.g., formalized assessment, requirements for elective procedural rights, etc.)


23. A Slice of the AMC Pie–Legal and Value Considerations around Service Line Carveouts (repeat)
Annapoorani Bhat, PYA, Charlotte, NC
Jeanna Palmer Gunville, Polsinelli PC, Chicago, IL

More Information

AMCs tend to be front runners when it comes to investing in important services for the community. Such investments may result in the development of new, innovative care protocols or new and profitable service lines, or they may end up creating substantial drain on scarce resources due to unforeseen circumstances or changing economy/industry trends. In some instances, it may be determined that these ventures will benefit financially and operationally from partnerships with, or a sale to, other health systems or private companies. Housed within the AMC’s legal structure, and dependent on overhead support from the system at large, it can be tricky to evaluate the profitability of these services, and bifurcate them from the overall AMC operations in preparation of a carve-out transaction. This session, which includes case studies, covers how AMCs and their advisors can prepare the organization for successful service line carveout transactions

 
4:30-5:30 pm

Networking Reception, sponsored by PYA
This event is included in the program registration. Attendees and faculty are welcome.

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Wednesday, February 7, 2024

7:00 am-12:00 pm

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

 
7:00-8:00 am

Continental Breakfast, sponsored by PYA
This event is included in the program registration. Attendees, speakers, and registered spouses and guests welcome.

 
7:00-8:00 am

Dispute Resolution Breakfast

Title: Making Arbitration Work for Providers
Geoff Drucker, Senior Director of Dispute Resolution Service, American Health Law Association, Washington, DC

This event is included in the program registration fee. Attendees and faculty are welcome.

More Information

This session covers best practices for drafting arbitration agreements, filing claims, and resolving cases efficiently and effectively.  We all learn from mistakes, but it's best to learn from the ones others have made!  Come join this special breakfast.

 
8:00-9:15 am

29. Be Curious, Not Judgmental: Things the DOJ “Believes” You Should Consider​ (not repeated)
Marc D. Goldstone, Executive Vice President and Chief Legal Officer, Wellpath, Nashville, TN
Caleb Knight, Flaherty Sensabaugh Bonasso PLLC, Charleston, WV
Kathryn Taylor, Senior Manager, ECG Management Consultants, Knoxville, TN

More Information

  • The Lasso Way: Describe current and future regulations that govern provider arrangements and resulting implications to organization operations

  • Details specific to recent enforcement actions related to the volume of cases by year and associated outcomes/settlement dollars

  • Trends in recent enforcement actions relate to specialty, compensation components and methodology, and documentation compliance

  • Teamwork Makes the Dream Work: Introduce the DOJ’s Health Care Fraud Unit

  • The Playbook of Trust: Summarize the DOJ Corporate Compliance Priorities


30. IND Manufacturing in the AMC Setting: cGMP, Contracting, Liability, Commercial Partnerships, COI, and Other Challenges (Advanced)
Delia Deschaine, Epstein Becker & Green, Washington, DC
Colleen Hittle, Founder, ProVeritas Partners, LLC, Indianapolis, IN
Jennifer Kulynych, Senior Counsel, Registered In-House Counsel, Stanford University Office of the General Counsel, Stanford, CA

More Information

  • Research-intensive AMCs are now manufacturing some of the investigational medical products for use in their own clinical trials. The manufacturing involved may be relatively simple or very sophisticated, with products ranging from mobile device health applications and food flours for allergy testing to cell and gene therapies that require aseptic processing facilities

  • Beyond FDA’s IND and IDE regulations, these projects are subject to FDA regulations specific to manufacturing, but the application of these manufacturing regulations to early stage (Phase I and II) clinical trials can be unclear

  • The panel consists of two attorneys who have navigated these issues in the AMC and industry environments and an expert regulatory consultant and engineer who is Lead Auditor trained and regularly audits clients for compliance with FDA’s Good Manufacturing Practice (GMP) requirements, including quality systems planning and architecture and risk-based remediation

  • Discuss various types of AMC manufacturing projects; the legal, insurance, business, and practical considerations involved in investigational product manufacturing; and the regulatory landscape, including FDA’s interpretation of its own manufacturing regulations in the context of academic manufacturing.  We will also touch on issues that may arise when collaborating with industry to manufacture investigational products in the AMC setting.

  • Reserved time for discussion and invite questions and commentary from the audience


18. Antitrust Enforcement in the Biden Administration: What Health Care Counsel Needs to Know (repeat)
Holden Brooks, McGuire Woods, Chicago, IL
​Karen Hunt, Deputy Assistant Director for Mergers IV, Federal Trade Commission, Washington, DC
Joseph Miller, Mintz Levin Cohn Ferris Glovsky & Popeo PC, Washington, DC

More Information

  • Merger policy – what’s new and what’s not for health care providers

  • Withdrawal of the Health Care Guidelines

  • Proposed rule on non-compete agreements in employment contracts

  • Private equity – why the hostility?

  • Increasing state AG interest in provider mergers

  • And much more


26. Managing 2024's Top Compliance Risks and Opportunities (Advanced) (repeat)
Anthony J. Burba, Barnes & Thornburg, Chicago, IL
Henry C. Leventis, United States Attorney, Nashville, TN
Ted Lotchin, Chief Compliance Officer, UNC Health, Chapel Hill, NC

More Information

This panel will present different perspectives on new and developing compliance risks and opportunities from the US Attorney for the Middle District of Tennessee, a former federal prosecutor specializing in defending organizations from allegations of fraud and abuse, and the chief compliance officer from an academic medical center and teaching hospital. The panel will cover topics including:

  • Government enforcement and audit priorities for the provider community in 2024

  • A review of recent enforcement actions involving academic medical centers, teaching hospitals, and physicians

  • New and evolving risks and benefits of AI and other clinical decision support tools

  • Recent developments in compliance challenges with physician relationships

  • Evaluating your organization's COVID enforcement risk

  • Addressing and mitigating information privacy and security threats

 
9:15-9:45 am 

Networking Break
Exhibits Open–Meet the Exhibitors

 
9:45-10:45 am

6. Private Equity - Be Careful, It Ain't Private Anymore (repeat)
John E. Kelly, Barnes & Thornburg, Washington, DC
Kim H. Looney, K & L Gates LLP, Nashville, TN

More Information

  • Is the expansion of the role of Private Equity in the health care industry a positive or a negative?

    • Pros

    • Cons

  • Why is the government focusing on PE investments in health care?

  • What factors increase the risk of government scrutiny of PE role in health care enterprise?

  • What types of actions/investments by PE are likely to garner media attention?

  • Antitrust scrutiny of PE investments in health care


9. Drug Pricing and Reimbursement Current Opportunities and Challenges (repeat)
Micah C. Burns, Division Counsel, Vanderbilt University Medical Center, Nashville, TN
Andrew D. Ruskin, K&L Gates Washington, DC

More Information

  • An illustrated discussion of the drug distribution chain and the hospital’s role therein

  • The Medicare program’s implementation of drug reimbursement reductions resulting from the Inflation Reduction Act

  • Update on the resolution of the Supreme Court decision reversing CMS 340B underpayments, both with respect to Medicare fee for service, as well as strategies for dealing with MA plans

  • State and Federal legislation and litigation affecting 340B utilization

  • Considerations for health systems as employers seeking to control their own drug spends


20. Advancing Diversity in Academic Medicine After the Harvard/UNC Cases (repeat)
Margia K. Corner, Senior Principal Counsel, University of California Office of General Counsel, Oakland, CA
Tahvia Jenkins, Athene Law, San Francisco, CA
Frank Trinity, Chief Legal Officer, AAMC, Washington, DC

More Information

Advancing diversity in the health care workforce remains critical to promoting health equity, improving patient experience, and improving patient safety.  These efforts are integral to the mission of academic medical centers.  The Supreme Court's decision in the Harvard and UNC cases poses new obstacles to racial diversity strategies in medical and other health professions schools.  But there are many public institutions, such as the University of California, that have several decades' worth of experience pursuing race-neutral diversity strategies.  This session is intended to facilitate a conversation about strategies that remain permissible after the Harvard/UNC decision and under state Constitutions/laws that prohibit preferential treatment based on race.  We will also address strategies that appear to vulnerable to future challenges and/or that may not survive scrutiny under these laws.


22. Legal Ethics Smooth Jazz - The Harmony Trio: Board Chair, President (CEO), and Legal Counsel (repeat)
Sandra M. DiVarco, McDermott Will & Emery LLP, Chicago, IL
Lisa Vandecaveye, Chief Legal Officer, The Joint Commission, Oakbrook Terrace, IL

More Information

  • Legal counsel support of governance and management – Who is the client? What rules apply?

  • Providing governance and management legal support in between meetings

  • Board and individual Board member duties – Accreditation and legal standards

  • Maintaining privilege and sharing information with management and governance

  • D&O coverage and immunity – Limitations and practical considerations

 
11:00 am-12:00 pm

14. Structuring Physician/Hospital Arrangements–Stark Law/AKS Considerations in Today’s Enforcement Climate (repeat)
Donna S. Clark, Norton Rose Fulbright, Houston, TX
Robert McStay, Chief Compliance Officer, Senior Vice-President, Memorial Hermann Health System, Houston, TX

More Information

This session will discuss Stark/AKS issues that arise in hospital/physician arrangements. In particular, we will address:

  • Employment and Professional Service Agreements (including common compensation models and warnings provided by recent settlements)

  • Transfer of funds between components of an AMC and the indirect compensation analysis under the Stark Law

  • Joint ventures involving hospitals and physicians

  • Physician recruitment agreements


28. Building Compliant Virtual Care Networks: Beyond Bricks and Mortar Into Innovation (repeat)
Mark S. Kopson, Plunkett Cooney, Bloomfield Hills, MI
Sarah E. Swank, General Counsel, On Belay Health Solutions, Washington, DC

More Information

Health care now is furnished not only in the provider’s office, but also in homes, offices, and other settings. Providers often are in different locations than their patients providing both in-person care and virtual care. In this intermediate-level session, the presenters will cover:

  • An overview of the key features of virtual provider networks (VPNs) and real-life examples of nursing, telehealth and ACO VPNs

  • How VPNs are impacting care delivery, payer-provider relations, network adequacy, and contracting

  • Development and implementation of a legally compliant structure and operations

  • Some of the most common and complex issues VPNs present, including corporate practice of medicine, licensing, supervision rules, and cyber issues

  • Practice pointers and practical solutions for professionals working with VPNs

11:00 am-12:15 pm Extended Session

30. IND Manufacturing in the AMC Setting: cGMP, Contracting, Liability, Commercial Partnerships, COI, and Other Challenges (Advanced) (repeat)
Delia Deschaine, Epstein Becker & Green, Washington, DC
Colleen Hittle, Founder, ProVeritas Partners, LLC, Indianapolis, IN
Jennifer Kulynych, Senior Counsel, Registered In-House Counsel, Stanford University Office of the General Counsel, Stanford, CA

More Information

  • Research-intensive AMCs are now manufacturing some of the investigational medical products for use in their own clinical trials. The manufacturing involved may be relatively simple or very sophisticated, with products ranging from mobile device health applications and food flours for allergy testing to cell and gene therapies that require aseptic processing facilities

  • Beyond FDA’s IND and IDE regulations, these projects are subject to FDA regulations specific to manufacturing, but the application of these manufacturing regulations to early stage (Phase I and II) clinical trials can be unclear

  • The panel consists of two attorneys who have navigated these issues in the AMC and industry environments and an expert regulatory consultant and engineer who is Lead Auditor trained and regularly audits clients for compliance with FDA’s Good Manufacturing Practice (GMP) requirements, including quality systems planning and architecture and risk-based remediation

  • Discuss various types of AMC manufacturing projects; the legal, insurance, business, and practical considerations involved in investigational product manufacturing; and the regulatory landscape, including FDA’s interpretation of its own manufacturing regulations in the context of academic manufacturing.  We will also touch on issues that may arise when collaborating with industry to manufacture investigational products in the AMC setting.

  • Reserved time for discussion and invite questions and commentary from the audience

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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]