Schedule

Tuesday, February 1, 2022

Wednesday, February 2, 2022

Registration and Check-In

Continental Breakfast
(This event is included in the program registration fee. Attendees and faculty are welcome.)

8:00-8:15 am
Welcome and Introductions
Cindy Reisz, AHLA President
Jeffrey Kahn, Program Committee Co-Chair
Kristen Kim, Program Committee Co-Chair

8:15-9:00 am
1. Intellectual Property and Global Health Equity: Implications for the Future
Sapna Palla
Sharon Reiche

• IP and its role in the innovation ecosystem
• IP and equitable access to new biomedical and genomics technologies and other health care innovations
• IP-related proposals to facilitate access to medicines and vaccines
  • WTO TRIPS IP waiver
  • Compulsory Licenses / March-in Rights
• Voluntary Efforts

9:00-10:00 am
2. Advancing Accountability and Equity through Payment and Care Delivery
Sara Cooperrider
Margia Corner
Erin Estey Hertzog

• The transformation of the US health care system is at an inflection point–Medicare, Medicaid and other payers are starting to hold providers truly accountable for the cost and quality of their care. These same payers and others acknowledge equity is a critical element of high-quality care
• Key developments in holding providers more accountable for the care they provide, including the CMS Innovation Center’s Direct Contracting Model and similar Medicaid and private-payer initiatives
• Other legal and regulatory frameworks that shape academic medical centers’ activities to promote health equity, such as the Community Health Needs Assessment and Implementation Strategy required for tax-exempt non-profit hospitals and state law population health and equity reporting requirements
• Nascent efforts by payors to promote health equity through payment and service delivery initiatives, together with an analysis of anticipated legal issues
• Bringing to bear the speakers’ diverse experience advising a wide array of private-and public-sector clients, we will then discuss common legal issues that arise in structuring participation in initiatives that involve taking on greater accountability for cost and quality, including:
  • Governance requirements
  • Financial arrangements (e.g., distribution of shared savings)
  • Patient engagement incentives
  • Data sharing and performance measurement
  • Quality reporting and stratifying by race, ethnicity and other social risk factors
  • Safeguards against stinting on medically necessary care, cherry picking, or otherwise steering patients
  • State law considerations (e.g., insurance licensure requirements, patient notice requirements, prohibition against corporate practice of medicine)

3. Privacy in the Research Lifecycle: Exploring Obligations, Obstacles and a Complex Web of Laws
(not repeated)
Hillary N. Kalay

• The different standards of “identifiable” information under research regulations and privacy laws
• Genetic data and how it is characterized under research regulations and privacy laws
• How institutional definitions and processes relating to identifiable data impact research review
• Considerations for sharing protected health information within a hybrid covered entity and to external sponsors for research
• Considerations for sharing information collected in performance of the research with sponsors, patients, and other health care providers

4. The Graduate Medical Education Landscape: What AMCs and Teaching Hospitals Should Know about Financial and Accreditation Issues​
(not repeated)​
Leah Gassett
Andrew B. Roth

On December 27, 2020, the Consolidated Appropriations Act of 2021 (CAA) was signed into law. As one of the largest spending measures ever enacted by the federal  government, the CAA combined COVID-19 stimulus relief with regular annual budget appropriations. The CAA included the following three graduate medical education (GME) provisions, making it the first significant GME expansion opportunity in more than two decades:

• New reimbursement for 1,000 additional residency slots over five years (Section 126)
• Expansion of funding for rural training programs and urban-rural partnership opportunities (Section 127)
• Opportunities to reset hospital FTE caps and per resident amounts (PRAs) (Section 131)
• Implications of the rulemaking process and how the CAA provisions were implemented, their impact on teaching hospitals, new questions that arose following the passage of the CAA, and what may be next.
• As well, there are important accreditation trends from the ACGME that AMCs and teaching hospitals need to be aware of:
• New ACGME Institutional Requirements affecting all AMCs and teaching hospitals, that became effective as of July 1, 2021
• The ACGME’s increased focus on “the learning and working environment,” and on resident protection as well as resident education

6. Grading the Curve: Understanding Value-Based Arrangements with AMCs
Ritu K. Cooper
Vanessa McKenzie

• Mechanics of the Value Based Rules
• Practical pointers on the Value Based Framework within the AMC setting through the evaluation of hypotheticals
  • When to rely on the VBE Stark Exceptions/AKS Safe Harbors
  • Considerations of outcomes-based payments to providers and beneficiaries
  • Application of FMV and Commercial Reasonableness
• What role does Compliance play under Value Based Arrangements
• The Pandemic’s impact on AMCs and Value Based Arrangements

7. Research Security and Foreign Collaborations: Navigating Increasingly Challenging Compliance Obligations and Enforcement Activity
(not repeated)
Amanda C. Ferguson
Christine G. Savage

• Navigating foreign influence investigations by funding agencies/DOJ while maintaining important research programs and good faculty relationships
• How agencies are identifying institutions/relationships of concern and examining recent shifts in enforcement activity
• Strategies counsel and compliance can use to implement research security into their existing research compliance programs without breaking the bank
• Tools for improving faculty education about traps for the unwary related to conflicts of interest and foreign components

8. Precision Medicine Studies: A Perfect Storm of Legal and Ethical Issues on the Line between Treatment and Research
Andrew P. Rusczek

Precision medicine may bring promise of better care to patients, but it also brings promise of complex legal and ethical issues to institutions and other providers that care for these patients. This session will identify some of these legal and ethical issues and describe how they can be addressed in the context of precision medicine studies. We will address the following topics, among others, in the context of precision medicine studies:

• Regulations and requirements of the FDA in relation to investigational devices (including LDTs and “Software as a Medical Device”) and investigational drugs
• Clinical Laboratory Improvement Amendments (CLIA) in relation to laboratories performing genetic analyses
• Applying FDA’s requirements for IRB review and informed consent
• Tort law risks in the context of individualized care

9. Intellectual Property (IP) from the Trenches in an Academic Medical Center
C. Patrick Turley

Key IP concerns and issues in an AMC. Or, “What this Nerd lawyer would like my Health Law colleagues to know.”

• Copyright ownership, classroom, and fair use with discussion of recent cases and practical tips
• Technology transfer under the Bayh-Dole Act, highlighting arcane provisions that can sideline deals
• Patent Wars: AMC vs. AMC:  Recent case where one AMC sued another AMC for patent infringement, with proposals to mitigate this happening again
• Educating faculty and trainees about IP issues and traps

6. Grading the Curve: Understanding Value-Based Arrangements with AMCs
(repeat)
Ritu K. Cooper
Vanessa McKenzie

• Mechanics of the Value Based Rules
• Practical pointers on the Value Based Framework within the AMC setting through the evaluation of hypotheticals
  • When to rely on the VBE Stark Exceptions/AKS Safe Harbors
  • Considerations of outcomes-based payments to providers and beneficiaries
  • Application of FMV and Commercial Reasonableness
• What role does Compliance play under Value Based Arrangements
• The Pandemic’s impact on AMCs and Value Based Arrangements

10. Data Governance in AMCs: A Winning Strategy for Privacy Boards, Institutional Review Boards, and Patients
Jill McCormack
Dawn Morgenstern

As Academic Medical Centers (AMCs) and Universities move in a direction to reduce costs and redundancies, unique challenges surface relating to the use and disclosure of protected health information for research. The lines become blurred when each is under common control and ownership and a shared services business model exists for certain functions. The key is the separation of responsibilities of the Institutional Review Board (IRB) and the Privacy Board, in relation to the data sets derived from the AMC’s electronic health records. The presentation will discuss the steps that VCU Health System has undertaken to address the challenges, leverage shared services, streamline processes for Principal Investigators, and develop practices to comply with the requirements of the HIPAA Privacy and Security Rules. We will discuss:

• The differences between an IRB and a Privacy Board
• The challenges when the University and Health System share resources
• Strategies for building cohesive programs that integrate IRB and Privacy Board processes

8. Precision Medicine Studies: A Perfect Storm of Legal and Ethical Issues on the Line between Treatment and Research
(repeat)
Andrew P. Rusczek

Precision medicine may bring promise of better care to patients, but it also brings promise of complex legal and ethical issues to institutions and other providers that care for these patients. This session will identify some of these legal and ethical issues and describe how they can be addressed in the context of precision medicine studies. We will address the following topics, among others, in the context of precision medicine studies:

• Regulations and requirements of the FDA in relation to investigational devices (including LDTs and “Software as a Medical Device”) and investigational drugs
• Clinical Laboratory Improvement Amendments (CLIA) in relation to laboratories performing genetic analyses
• Applying FDA’s requirements for IRB review and informed consent
• Tort law risks in the context of individualized care

9. Intellectual Property (IP) from the Trenches in an Academic Medical Center
(repeat)
C. Patrick Turley

Key IP concerns and issues in an AMC. Or, “What this Nerd lawyer would like my Health Law colleagues to know.”

• Copyright ownership, classroom, and fair use with discussion of recent cases and practical tips
• Technology transfer under the Bayh-Dole Act, highlighting arcane provisions that can sideline deals
• Patent Wars: AMC vs. AMC:  Recent case where one AMC sued another AMC for patent infringement, with proposals to mitigate this happening again
• Educating faculty and trainees about IP issues and traps

3:30-3:45 pm
Welcome and Introductions
Julie Kass, Program Committee Co-Chair
Kristen Woodrum, Program Committee Co-Chair

3:45-5:30 pm
11. Year in Review
S. Craig Holden
Robert G. Homchick
Kristen B. Rosati

While health care lawyers are used to constant change, this last year was a real head-spinner. Our speakers will thus take you on a “spin” through these developments to highlight significant changes we should all know about, including:

• Health care reform: Biden Administration efforts to enforce and expand the Affordable Care Act, and significant decisions by the Supremes
• COVID-related legislation, claims and other developments (because no, it’s not over yet)
• Sprinting to value-based care and continuing challenges with (fraud &) abuse
• Telemedicine’s new spot at the adult table
• “HIT”-ing the deck: information blocking and interoperability, OCR enforcement, data breaches and new state laws
• But wait… there’s more!

Thursday, February 3, 2022

Registration and Check-In

Continental Breakfast
(This event is included in the program registration fee. Attendees and faculty are welcome.)

12. Language Access Rights in Health Care: Improve Equity and Avoid Complaints and Litigation​
(not repeated)
Dylan N. De Kervor
Toby K.L. Morgan
Andrew C. Stevens

• Section 1557 of the Affordable Care Act requires health systems to take proactive steps to provide meaningful access for individuals with Limited English Proficiency and to provide equal access to individuals with disabilities, including individuals who speak American Sign Language
• Federal law thus requires health systems to provide language assistance services to these patient populations free of charge, which may include oral interpretation services by phone, written translation services, Video Remote Interpreting, in-person interpreters, and other auxiliary aids and services for individuals with disabilities
• The statutory and regulatory landscape underlying these obligations and review recent litigation in which plaintiffs have alleged a failure to provide appropriate language assistance services or auxiliary aids
• The legal standards applicable to such claims, the potential remedies, and the potential enforcement mechanisms (such as class actions, federal investigations, and private enforcement)
• Concrete steps that health systems, including academic medical centers, should take to operationalize compliance, minimize risk, and effectuate communication-equity for all patients and/or research participants

13. Look on the Bright Side: The Expansion of Telehealth During (and after) COVID-19
(available on demand only)
Adam M. Walters

• Telehealth
• Medicare reimbursement policy for telehealth
• Pre-pandemic
• Changes during pandemic (both PHE temporary and permanent)
• Federal regulatory barriers to telehealth
• State expansion of telehealth during pandemic
• Private payor initiatives and policy

14. Difficult Transactions in Health Care and How to Overcome Them​
(not repeated)
James Bowden
Ethan E. Rii

• Reasons for increasingly difficult health care transactions and key touch-points to consider
• How implementing a workable process and framework can preemptively address a host of structuring, regulatory, and drafting hurdles
• Key approaches in spotting and resolving emerging underlying legal, regulatory, and business issues before they overwhelm a transaction
• Examples of relevant negotiating areas and best practices (case studies)

15. Stark, Kickback and Value-Based Care: Lessons Learned After a Year of Reform
(not repeated)
Christopher Sellers
Joseph N. Wolfe

In this session, panelists will discuss the Stark, Kickback and value-based regulatory changes. Topics covered will include:

• The current state of the regulatory changes
• Highlights and lessons learned from trenches, including the "Big 3”
• Compliance and implementation considerations and value-based care
• The "special rules" on directed referrals
• The new bright- line volume/value rule and examples of arrangements that will pass (or fail) these new rules based on guidance in the final regulations

16. The Growing Threat: Kickback Enforcement in the Private Payor World
(not repeated)
Allan Medina
Alexander F. Porter

• Increased efforts by the US Department of Justice to bring kickback prosecutions in cases that do not involve Federal health care programs. The panelists will review the types of cases that have been brought against physicians and hospitals involving private health insurance plans
• The charging theories the DOJ has used when pursuing kickback cases involving private health insurance plans, including honest services mail/wire fraud charges, Travel Act charges, and charges brought pursuant to the Eliminating Kickbacks in Recovery Act (“EKRA”)
• The similarities and differences between these cases and  more traditional kickback cases charged involving Federal programs under the Anti-Kickback Statute
• Practical tips to physicians and compliance/legal professionals about how to guard against the risk of prosecution under these evolving DOJ charging theories

17. Emerging Trends in Physician Employment/Independent Contractor Contracting and Compensation Arrangements with Hospitals
(not repeated)
Martin D. Brown
Robert A. Wade

• Physician compensation approval, implementation, and monitoring best practices
• Emerging compensation arrangements including Value-Based Arrangements, quality, patient access, and bundled payments
• How are emerging contracting compensation arrangements complying with legal/regulatory requirements?
• How do emerging contracting compensation arrangements further integration for AMCs/hospitals/physicians?

18. Legal Ethics: When Boards are not Boring - What to Do When a Client Puts the Attorney in the Middle
(not repeated)
David A. DeSimone
Sarah E. Swank

• The ethical rules and responsibilities for attorneys related to their response to management and the board of hospitals and physician organization, including potential pitfalls when the lawyer becomes part of the conflict
• What can go wrong with real life examples, including lessons learned from recent cases 
• How does it work in practice, hypotheticals of board and other conflict of interest scenarios, including when attorneys are asked to serve on Boards, conflict arises at a meeting and when management is not acting in the best interest of the client
• The ethics of moving forward or withdrawing from the representation and what that means for the in house and outside counsel
• Prevention and resources including practical recommendations including policy consideration, governance best practices, and board training

19. Ensuring Physician-Hospital Transactions Will Survive Future Compliance Scrutiny​
(not repeated)
Kristin M. Bohl
Albert D. "Chip" Hutzler

• Top 10 physician contracting compliance risk areas, including False Claims Act, Stark Law, Anti-Kickback Statute, and other compliance concerns
• What happens when there are compliance and documentation problems–review of the consequences of noncompliance or poor documentation
• How to avoid compliance concerns in transaction terms
• How to ensure documentation is compliant and litigation ready, should any need arise to defend the transaction later
• How have the risk areas been affected by new regulations, the COVID pandemic, and the associated waivers

20. Health Care Antitrust Enforcement in the Biden Administration: A New Frontier?
(not repeated)
John D. Carroll
Jared P. Nagley
Subramaniam (Subbu) Ramanarayanan
Jane E. Willis

• The health care industry has been a target of federal and state enforcement for years but may now be at a high water mark in the Biden administration
• Our panel, which includes two former FTC enforcers, will discuss the key antitrust issues facing hospitals and physicians as they navigate a challenging enforcement landscape
• Analyze how recent developments at the FTC and DOJ are impacting the health care industry
• Antitrust issues associated with transactions and clinically and financially integrated multi-provider networks, as well managed care contracting and exclusive contracts between hospitals and physician groups

21. Virtual Care, a Pandemic, and the Future
(not repeated)
Priya J. Bathija
Melissa Myers
Kimberly E. Peery

During the COVID-19 pandemic, virtual care–including mobile health apps, patient portals, remote monitoring, and telemedicine–became a critical way for health care providers to reach patients. This session will provide an overview of this shift in care delivery at a national level. Speakers will share real examples of virtual solutions implemented by hospitals and health systems and how those hospitals navigated the legal and regulatory flexibilities offered throughout the public health emergency. Speakers will also offer insights from their different vantage points–strategy, policy, and legal–into how services will be redesigned in the future and how virtual care can serve as the basis for other care delivery models, such as hospital at home. This will include perspectives on the benefits and challenges of this transition to virtual care, key decisions that must be made and the legal, payment, and policymaking considerations that are at play.

• From real-life examples, understand how care delivery shifted throughout the pandemic
• What decisions were made to accommodate this shift, including an overview of the legal and regulatory flexibilities that became available
• Key decision points that must be evaluated as hospitals and health systems move into the future, including the legal, payment and policymaking considerations at play
• The ongoing benefits and challenges associated with virtual care

22. Fair Market Value in Health Care–Year in Review: A New Stark-ly Different Post- COVID World, One Year Later
(not repeated)
Kelly R. Anderson
Andrea M. Ferrari

This session provides a review of the previous year’s major developments related to or implicating fair market value and commercial reasonableness as regulatory requirements, and uses the recap as the basis for a “Top Ten” list of issues for counsel, compliance officers and valuation analysts to be aware of for the coming year. This year’s session will address the ongoing and residual impacts of COVID-19 and related and potentially transformative temporary and permanent regulatory and payment changes, how things have changed under the Stark Law and Antikickback final rules, the impact of the significant changes in the 2021 and 2022 Physician Fee Schedule rules and the “hot topics” of the year, including data, coordinated care incentives, and provider recruitment and retention. The basic outline for the program is as follows:

• Our opinion of the “Top Ten” FMV issues of the year
• A recap of the previous year’s regulatory actions, court cases, settlements and other developments  that focus on and/or otherwise relate to fair market value and commercial reasonableness in hospital-physician transactions, including major court decisions and settlements, trends and developments under the new Stark Law and Antikickback Final Rules (including the new Stark Law definitions of the “Big Three” and new provisions for value based arrangements), telemedicine, new and changing developments and trends in criminal prosecutions rooted in compensation relationships, and the continuing  effects of the COVID-19 public health emergency on compensation trends, survey data and fair market value
• How these developments might reflect, challenge and/or affect prevailing legal perspectives and operational processes regarding hospital-physician arrangements, including of what to look for and how to analyze relationships, and, in particular, how parties do or should approach questions of fair market value and commercial reasonableness
• Practical takeaways for counsel, compliance officers, healthcare executives and valuation analysts in the current/eventual post-COVID era

• Regulatory underpinnings of acceptable hospital charge structures
• Fundamentals of the Price Transparency Rule and open items
• Fundamentals of the No Surprises Act including new patient disclosures, notices, and consent requirements to waive patient balance billing protections and the independent dispute resolution process
• Impact of the rules on payer practices
• Impact on provider relations with payers, patients, and other hospitals in the same market