Tuesday, January 31, 2023
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7:00 am-5:15 pm |
Registration and Check-In
If you have not checked in, come to AHLA Registration area to print out your badge. We'll need your proof of vaccine or negative COVID-19 test on the Clear Health App.
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7:00-8:00 am |
Continental Breakfast
This event is included in the program registration fee. Attendees and faculty are welcome.
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8:00-9:45 am General Session |
8:00-8:15 am
Welcome and Introduction
Thomas Shorter, AHLA President
Kristen Woodrum, Program Committee Chair
8:15-9:45 am
1. Year in Review
S. Craig Holden, Baker Donelson, Baltimore, MD
Robert G. Homchick, David Wright Tremaine LLP, Seattle, WA
Cynthia F. Wisner, Associate Counsel, Trinity Health, Livonia, MI
Promising to be more entertaining than watching paint dry, our newly reorganized panel (welcome, Cindy Wisner), will cover key developments over the past year and identify industry and enforcement trends. Highlights include:
- Post-Dobbs fallout 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
- The rise of telemedicine and its survival past the end of the Public Health Emergency
- Health Care Transactions (from hot trends, to record number of bankruptcies, to private equity, to tax issues, to new antitrust theories)
- Hot HIT developments (cyber-attacks, information blocking and interoperability, OCR enforcement, and new state laws)
- The Surprising first year of No Surprises
- Updates on price transparency and drug prices
- Reimbursement trends and 340B
- And much more!
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9:45-10:15 am |
Networking Break
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10:15-11:30 am Extended Concurrent Sessions |
2. The Provider's Role in Advancing Health Equity (not repeated)
Dawn Hunter, Network for Public Health Law, St. Petersburg, FL
Ashley Keith-Phillips, Assistant General Counsel, University Hospitals Health System Inc, Cleveland, OH
- Health equity in the health care provider setting
- Laws and policies that shape health outcomes
- Health equity frameworks and implementation strategies for hospitals and physicians
- Best practices and health system examples
3. Value-Based Care: Options, Barriers, Opportunities and the New Normal (not repeated)
Jason D. Stevens, Senior Vice President and Deputy General Counsel, Wellstar Health System, Marietta, GA
Elizabeth R. Hammack, Deputy General Counsel, University Hospitals, Shaker Heights, OH
4. Health Care Transaction Reviews-A Decade in Review: What’s Old is New Again (Advanced)
Kelly R. Anderson, Associate General Counsel, Baptist Healthcare System, Louisville, KY
Andrea M. Ferrari, Sr. Principal and General Counsel, Pinnacle Healthcare Consulting, Boca Raton, FL
John Fink, ECG Management Consultants, San Diego, CA
- The prior year’s court cases, regulatory actions, and other developments of note for physician and other healthcare transaction reviews
- Our opinion of the top ten issues of concern and what counsel, compliance officers, and consultants need to know about them
- A recap of the major issues of the past decade and how they compare to the past year, including recurring themes and what has changed or remained the same
- Our outlook, tips, and takeaways for navigating trouble spots efficiently and effectively in 2023
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11:30 am-12:00 pm |
Coffee and Networking Break
Exhibits Open–Meet the Exhibitors
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12:00-1:00 pm Concurrent Sessions |
5. What’s the Big Deal? Tips on Transactions Involving “Big Data” and Genomics (Advanced) (not repeated)
Scott Elengold, Associate General Counsel, Duke University, Durham, NC
Kristen B. Rosati, Coppersmith Brockelman PLC, Phoenix, AZ
AMCs and hospital systems are increasingly being approached to share huge volumes of clinical data, biospecimens, and genomics sequencing data derived from those biospecimens with a variety of partners, including pharmaceutical companies, biotech companies, AI and machine-learning companies, and other collaborative research partners. This will be a masters-level program that will cover the following topics:
- What are best practices for handling identifiable and de-identified data in these transactions in a manner that complies with HIPAA and state privacy laws?
- What special protections are warranted for genomics data given the evolving state genetic privacy laws and the sensitivity of this information?
- What research compliance issues are presented through structuring these deals as collaborative research efforts?
- What are particularly challenging business issues presented by these deals, such as structuring equity investments, warrants and other compensation for engagement in these collaborations?
- What IP issues are presented in these deals?
6. Legal Ethical Challenges for the Health Lawyer Regarding Unique Financial Arrangements with Clients
David A. De Simone, Freehold, NJ
Sarah E. Swank, Nixon Peabody, Washington, DC
- Examples of financial relationships between attorney and health care client
- Ethical rules impacting financial relationships with clients
- Judicial and regulatory oversight
- Hypotheticals
- Lessons learned and recommendations
7. Structuring Care Management and Remote Patient Monitoring Arrangements: Reimbursement Standards, Regulatory Compliance and Collaboration Structures
Rick L. Hindmand, McDonald Hopkins LLC, Chicago, IL
Richelle D. Marting, Marting Law LLC, Olathe, KS
- Common uses of chronic care management (CCM), transitional care management (TCM), remote physiologic monitoring (RPM), and remote therapeutic monitoring (RTM)
- Medicare reimbursement standards and issues for care CCM, TCM, RPM, and RTM
- Structures for collaborations among health care providers, practitioners, IT/digital health vendors, consultants, clinical staffing companies, and management companies
- Contracting considerations in structuring collaborative care management, RPM, and RTM arrangements
- Compliance concerns relating to care management, RPM, and RTM
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1:00-2:15 pm |
Networking and Presentation Lunch
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.
Before it Becomes a Law, Your Role as an Advocate in Policy Development
Kristen McDermott Woodrum (Moderator), McGuireWoods LLP, Atlanta, GA
Priya J. Bathija, Founder & CEO, Nyoo Health, Adjunct Professor, Loyola University of Chicago, School of Law, Chicago, IL
Melissa Myers, Vice President, Policy, Premier Inc, Alexandria, VA
To kick off the session, speakers will provide a brief overview of the key drivers for health policy in the United States and the policy process. They will then dive into current health policy issues, challenges and considerations facing stakeholders in the health care ecosystem, including hospitals, health systems and physicians. Throughout this session, speakers will provide case studies for how you may advocate for policies that benefit your clients. Attendees will leave understanding:
- Key drivers for health policy in the United States
- Health policy issues and considerations currently in play and the impact they have on hospitals, health systems, and physicians
- Ways in which attorneys can influence policy on behalf of their clients
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2:30-3:45 pm Extended Concurrent Sessions |
8. Is Your Health Data Sloshing Out of the Privacy Bowl? Preventing PHI Spills and Other Data Misuse (not repeated)
Elizabeth F. Hodge, Akerman LLP, West Palm Beach, FL
Gerard M. Nussbaum, Zarach Associates, LLC, Chicago, IL
Sean T. Sullivan, Alston & Bird, Atlanta, GA
- Data universe
- Data movement, processing, and retention
- Legal and regulatory authority; liability for providers and other actors
- Patient and provider initiated sharing of PHI
- Case examples
9. Antitrust Update
Kevin Hahm, Hunton Andrews Kurth LLP, Washington, DC
Joe Miller, Mintz Levin Cohn Ferris Glovsky & Popeo PC, Washington, DC
Christine L. White, Vice President—Legal Affairs, Northwell Health, New Hyde Park, NY
- Antitrust refresher
- Top 10 antitrust issues for a health care GC or Generalist
- Update from DC: Navigating today’s changing landscape
- Ask me anything–Lightning Round
10. New Technology: Considerations for Evaluation, Development, and Implementation
Lara D. Compton, Mintz Levin Cohn Ferris Glovsky & Popeo PC, Los Angeles CA
Sylvia Coyle, Director, Corporate Compliance & Privacy Officer, Valley Children's Healthcare, Madera CA
Veronica Marsich, Chief Health Counsel, UC San Diego, San Diego CA
Health systems are in the process of digital transformation and are using a combination of internally developed, jointly developed (e.g. with third parties through joint ventures and pilot programs) and commercially available technologies. Each of these approaches can present regulatory issues and operational challenges, particularly if the technologies have a patient-facing component, including:
- Vendor evaluation and engagement processes
- Privacy and security of health information
- Compliance with Medicare Conditions of Participation and The Joint Commission standards
- Patient and consumer rights
- Human research requirements–drawing the line between research and product evaluation
- Interoperability of technologies
- FDA regulation of developed software
- Relationships that implicate fraud and abuse laws
- Risk management and appropriate clinical review of digital tools offered to patients
- Diversity, inclusion, and health equity considerations
11. Reporting from the Trenches - A False Claims Act Enforcement 2022 Recap and Predictions for 2023
George B. Breen, Epstein Becker & Green, PC, Washington, DC
Thomas F. Corcoran, Chief, Civil Division, United States Attorney’s Office, District of Maryland, Baltimore, MD
Jeffrey W. Dickstein, Phillips & Cohen LLP, Miami, FL
The program–featuring experienced government, defense, and relator’s counsel–will spotlight select False Claims Act investigations, litigations, and settlements pertinent to hospitals and physicians in 2022. The panel will focus on sharing practical tips for handling these matters and will also address expectations for enforcement priorities and risk areas in 2023. Topics include:
- Recap of focus areas of enforcement specific to physicians and hospitals in 2022
- Recent settlements, judicial decisions and regulatory changes that may impact False Claims Act enforcement in 2023
- Insights and practical tips, using “real world” examples, for handling both investigations and FCA litigation
- Risk and compliance areas for 2023
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4:15-5:15 pm Concurrent Sessions |
12. Private Equity’s Increased Interest in Health Care: How to Advise Medical Practices (Advanced) (not repeated)
Kim Harvey Looney, K&L Gates LLP, Nashville, TN
Michael F. Schaff, Wilentz Goldman & Spitzer PA, Woodbridge, NJ
- The Private Equity Business Model
- Why are private equity firms interested in medicine?
- The typical terms of a Private Equity Deal
- Regulatory issues presented by private equity deals
- Legal traps and how to avoid them
- What does the influx of private equity mean for physicians and other health care providers?
- Practical advice and tips in advising clients
13. The Anatomy and Pathology of the Deal - A Post Mortem Analysis (not repeated)
Regina Gurvich, Chief Compliance & Risk Officer, OMNI Ophthalmic Management Consultants, New York, NY
Daniel Meier, Benesch Friedlander Coplan & Aronoff LLP, Hackensack, NJ
- Case study of a deal gone awry including next steps for growth, potential self-disclosures, repayments and claims
- The Morning After: Escrows, R&W Insurance, root cause analysis, audits, and policies and procedures
- Collateral Damage: How to handle employees, contractors, and vendors that may have been caught up in the issue
- Post Mortem: Avoiding missteps through contract review, security assessments, billing trend assessments, and coding and documentation review
- Lessons learned from successes and fiascos, actionable pointers, and a few tools to make it all work
14. Growth of Advance Practice Providers (NPs, PAs, CRNAs, Midwifes) in Hospital Settings and Practical Tips to Mitigate Regulatory Risk for Physician-APP Shared Patients
Holley Thames Lutz, Dentons US LLP, Washington, DC
Bruce J. Toppin, Chief Legal Officer, North Mississippi Health Services Inc, Tupelo, MS
- Role of Advance Practice Providers (APPs) on the medical staff, including physician oversight, credentialing, and privileges
- Can APPs be members of a medical staff equal to physicians • Limitations on APPs by State law
- Federal Regulations and their intersection with State Boards of Nursing and Physicians
- Identify Fraud and Abuse/Stark risks when utilizing hospital-employed (or independent) APPs to support inpatient service lines (including surgical service lines)
- Pro Fee Billing by APPs and physicians who share a patient (within the same group or not)
- Practical tips, "do's and don'ts" for optimizing operational and patient care goals and limiting compliance risk
15. Information Blocking: Chaos, Confusion, and Non-Compliance
Marti Arvin, Chief Compliance and Privacy Officer, Erlanger Health System, Chattanooga, TN
Joseph Dickinson, Nexsen Pruet, Raliegh, NC
- The Information Blocking Rule: Requirements and exceptions
- Compliance with the IB Rule was not intended to eliminate information protection
- Why most organizations are still not compliant with the IB Rule
- The impact of the October 6, 2022 compliance date
- Where it is at and what it means
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5:15-6:15 pm |
Networking Reception
This event is included in the program registration. Attendees and faculty are welcome.
Sponsored by PYA
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