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Annual Meeting 2021

Sessions By Topic

Click below to jump to that topic and corresponding sessions:

 

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1. Year in Review
Robert G. Homchick
Kristen B. Rosati
Michael F. Schaff

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 Supreme Court
  • 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!

12. Keynote Address
Anthony S. Fauci, MD
Christi A. Grimm

28. Keynote Address: Tech Innovation and Disruption in the Health Care Ecosystem: Impact on Patient Experience and Outcomes
Indu Subaiya
This general session is sponsored by FTI Consulting.

In this keynote, Dr. Subaiya will be outlining key developments in the digital health industry, especially as we emerge from the pandemic. She will explore the barriers to realizing the full potential of innovation including data stewardship, incentives, access and equity as well as the opportunities to overcome those barriers as we build the health system of the future.

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Antitrust

24. Being on Your Best Behavior: Examining Problematic Antitrust Conduct
Vic Domen
Dionne Lomax
Peter Mucchetti
Tracy Wertz

Antitrust investigations and litigation continue to be in the spotlight, including high-profile matters concerning Geisinger Health in Pennsylvania and Blue Cross licensees in Alabama. Using current cases as examples, this program will identify and explain competition concerns raised by:

  • Contractual restrictions an insurer's ability to steer patients to competing healthcare providers
  • Partial acquisitions
  • Exclusive contracts
  • Agreements not to solicit employees or to fix wages
  • Other limits on competition that can attract the attention of government enforcers and private plaintiffs

37. Getting Your Deal Through: How to Advance Systemness, Promote Integrated Care Delivery, and Successfully Defend Vertical and Horizontal Transactions
Meg Guerin-Calvert
Bevin M.B. Newman
Jeffrey A. Kraut

  • Antitrust enforcement tends to rely on “one-off” transactional reviews that utilize standardized frameworks focused on price effects, and enforcement authorities have expressed skepticism about the need for industry transformation to emerge from the current pandemic, as well as the benefits that accrue from achieving integration and systemness among health care industry participants
  • Broader study exploring the longer-term benefits of systemness to support business investment in and enforcers’ understanding of the role of scope and scale to attaining an integrated approach to delivering care
  • Evaluating and integrating specific investments and acquisitions into a company’s strategic approach to operations and transformational change; thereby enhancing the ability to demonstrate their benefits to regulators, boards, and communities
  • Market factors and conditions, as well as antitrust issues facing health care businesses seeking to engage in transformational transactions and develop best practices/attributes of successful integrated systems:
  • Increasingly broad and integrated health care delivery systems with multiple hospitals, physicians, outpatient services, ASCs, UCCs, and other providers that span and manage a broad scope of economic and health care activity within expanding regions
    • Smaller standalone providers (hospitals, physicians, outpatient, ASCs) seeking partnerships because they face increasing pressures and lack critical infrastructure or sufficient scale, and scope; and as exacerbated by the COVID-19 pandemic, leading to closures of rural, safety net, and smaller urban hospitals, or inability to fund needed investments, and increased pressure to downsize or limit operations
    • Insurers (and providers) seeking to develop more integrated networks, new contracting practices, and provider arrangements that include focus on partnering with health care delivery partners to manage care and meaningfully reduce shorter term and especially mid to longer term costs of care for their insured populations
    • Provider and payers facing pressures from business, customers, and public health authorities to deliver on successful integrated care delivery, improved outcomes across the spectrum, and reduced costs

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Behavioral Health

9. Now Trending in Behavioral Health: Integration Strategy, Regulatory Compliance, and Transactions
Clint Flume
Jeanna P. Gunville

  • Evolving delivery models addressing behavioral health needs: clinical integration, affiliation, collaborative care leveraging telepsychiatry and other telehealth services
  • Key compliance issues facing the industry, recent regulatory changes in response to the opioid crisis and coronavirus public health emergencies, and impact to future progress
  • Key players, alignment strategies, and transaction trends that will shape the industry in 2021 and beyond

14. Ensuring Mental Health Parity During and after a Pandemic
Brad Lerner
David Lloyd

The Mental Health Parity and Addiction Equity Act (MHPAEA) was enacted over a decade ago. While The Kennedy Forum and health plans have often worked together to expand coverage of mental health and addiction treatment, they have not always seen eye-to-eye on state and federal regulatory requirements, particularly relating to MHPAEA. We will discuss:

  • Perspectives on MHPAEA successes and challenges
  • Broader inequities in access to mental health and addiction treatment, including the impact of court cases relating to medical necessity criteria
  • Impact of new amendments to MHPAEA and related guidance as well as prognosticate as to what to expect with regard to parity in the coming year, both from a federal and state legislative and regulatory perspective
  • How payers, providers and advocates are responding to increased mental health and substance use needs associated with the COVID-19 pandemic

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Business Law and Governance

8. Health Care Governance in the Real World: What National Surveys Are Telling Us
Anne M. Murphy
Kathryn G. Peisert
Michael W. Peregrine

The presenters jointly developed a governance survey for The Governance Institute (TGI) and the American Health Law Association (AHLA) that was distributed nationally in 2020 to governing board members, executives, and in-house counsel for health care provider organizations. The TGI/AHLA survey results provide a unique opportunity to assess the state of governance in health care today. These TGI/AHLA results will be compared to the 2021 Association of Corporate Counsel (ACC) Chief Legal Officers Survey, and the 2021 EY Law Survey, each of which provides broad insight into in-house counsel roles and challenges across industries. The presenters will share their insights into key survey takeaways:

  • Board size, composition, and competency trends, examining factors such as board "refreshing" methods and relative emphasis on criteria such as specific subject matter expertise, racial and ethnic diversity, independence, and fundraising capacity 
  • Interface between the board and certain key executives, with a focused look at the relationship between the board and legal counsel
  • Trends in General Counsel reporting relationships, seniority, and involvement in strategy, as well as projections regarding legal budget and top legal challenges
  • Pressing resource and subject matter expertise needs of governing boards, and how those are being addressed
  • Current year and 5 year strategic priorities of the organization, comparing pre-pandemic and more current perspectives
  • How health care governing boards are approaching sea changes such as the shift to value-based purchasing, non-traditional ventures with industry, artificial intelligence, continued consolidation, the changing future of the workplace, and the emerging importance of ESG and diversity and inclusion
  • Compare the survey results with governance best practices, and will identify practical means for using the survey results to facilitate governance-related discussions at health care organizations

13. Deep Dive: Stark and Antikickback Statute Compliance in Hospital / Physician Transactions
Kim Harvey Looney
Michael E. Paulhus

Two experienced counsel who have handled different sides of physician/hospital transactions, and subsequent defense of investigations concerning the same, will grapple with the nuances of how Stark and AKS are applied to a physician transaction. These issues will be brought to life by audience participation and hypothetical discussions based on fact patterns in reported cases/settlements, including discussion on the following topics:

  • Exceptions and Safe Harbors that may apply (or not)
  • Implications of the new Stark and AKS rules that became effective January 2021
  • Conceptual framework to evaluate how Stark commercial reasonableness and the facts and circumstances analysis of AKS intent overlap
  • The difference between case law's concept of "hopes and expectations" of referrals and actions that actually cross the line
  • Other practical guard rails to consider in a transaction

37. Getting Your Deal Through: How to Advance Systemness, Promote Integrated Care Delivery, and Successfully Defend Vertical and Horizontal Transactions
(See Antitrust for full description)

II. Burgers, Fries and … Botox?  Franchising a Health Care Provider
Jesse A. Berg

  • Franchising as a business model—how it works, pros and cons of franchising a business, different considerations that apply to franchisors as opposed to franchisees, how franchise principles can apply to health care businesses, along with the nuts and bolts of creating a franchise and how those concepts comport with standard health care transactions
  • Application of critical health care principles to franchises, including corporate practice of medicine, self-referral, anti-kickback and fee splitting concerns; marketing and advertising restrictions; Medicare, Medicaid and commercial payor considerations; HIPAA and state law privacy / security obligations; and a number of other important concepts
  • Key federal and state franchise laws, including franchise investment and disclosure laws, franchise relationship laws and guidelines on franchise marketing and sales and the importance of avoiding the accidental franchise
  • Various franchise business models, including unit franchise arrangements, micro franchises, regional developer businesses and area representative arrangements and how these concepts fit within the health care industry
  • Consequences of violating the franchise laws as compared to consequences of violating health care laws, as well as tips for explaining “health law” to lay investors and “franchise law” to health care providers

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Compliance

5. Not Everything is Illegal! Mitigating Risk by Clearly Distinguishing between Regulatory Requirements and Guidance
Michelle Bergholz Frazier, J.D., CHC-SVP
David M. Glaser

  • Suggestions for improving your hiring process for compliance professionals
  • Tips for explaining complicated rules and the legal hierarchy to both compliance professionals and medical professionals
  • Strategies for analyzing contradictory “expert” opinions and reducing the legal anxiety that can prompt employees to become external whistleblowers
  • Examples of situations where compliance professionals correctly, or incorrectly, concluded something was illegal

25. Managing Conflicts Across the Institution: Reducing Silos to Mitigate Risk
Amanda Ferguson
Hoyt Y. Sze
Max C. Weber

Institutions face a wide range of regulations that require thorough understanding of the financial interests and outside activities of its personnel. At many institutions, disclosures occur in silos, creating risk that disparate disclosures are submitted to oversight bodies or are not accessible to key stakeholders for better mitigation of potential risk. Implementing a holistic, unified conflict management process allows institutions to mitigate enforcement actions associated with major disclosure processes, such as foreign influence in academic research, and self-dealing, but requires thorough understanding of the regulatory and organizational environment.

  • Industry trends that are moving away from the siloed approach to conflict management and why as well as the models used for managing these broader conflicts systemwide
  • Common disclosure requirements to which health care systems, universities and AMCs are subject
  • Varying disclosure populations and disclosure types across the institutions
  • Risks associated with various disclosure types
  • Strategies for consolidating and streamlining disclosures and moving toward a holistic conflict management program

34. Get Your Group in Order: Ensuring Group Practice Compliance with the Physician Self-Referral Law
Nicholas Alarif
Albert Shay
Lisa Ohrin Wilson

  • CMS’ final regulations on the “Big 3” and their application to group practice internal and external compensation arrangements
  • The critical requirements for qualification as a group practice and practical tips for ensuring compliance with them
  • Changes effective January 1, 2022 regarding the distribution of group practice profits from designated health services and what group practices need to do to prepare
  • Practical tips for addressing potential noncompliance and making self-disclosures to CMS’ Voluntary Self-Referral Disclosure Protocol

IV. Why “Best Practice” Separates Legal from Compliance
Ellen M. Hunt
Jack Rovner

  • Why “best practice” separates an organization’s compliance function from its legal function
  • How real world cautionary tales show the dangers of the inherent conflict between the roles, expectations and responsibilities of compliance versus legal
  • Why compliance serves an external function that favors transparency in enforcing an organization’s pledge of ethical business conduct
  • Why legal serves an internal function, operating under the obligation to maintain client confidences in protecting the organization’s interests within the bounds of the law
  • Why compliance and legal must cooperate, coordinate, and complement each other to work in tandem for the best benefit of the organization served

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Dispute Resolution

30. Arbitration of Out-of-Network Billing Disputes: A Survey of Newly Adopted State Regimes
Mitchell Hasenkampf
Evan Neadel

  • No Surprises Act – what Payers and Providers need to know
  • State mandatory arbitration regimes and the interplay of those regimes with the federal legislation - NY, NJ, TX, VA, ME, GA
  • Lessons from the states on the mandatory arbitration process
  • Sources of pricing data to be relied upon by the arbitrators
    • Databases to be created by the federal legislation
    • Data newly available as a result of the Hospital Transparency Rule and, eventually, the Payor Transparency Rule
    • Existing databases like Fair Health

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Diversity

2. A Model for Building Health Equity - Addressing Social Determinants of Health through Value Based Payment
Heidi Arthur
Arthur J. Fried
Giovanna Rogow

  • Effectively addressing population health requires a focus on social determinants of health
  • The Pathways Community Hub model (“PCH”) is a service delivery model recognized by government and accreditation centers
  • PCH is an evidence-based, population-focused, pay-for-performance, care coordination approach focusing on activating community health workers in community-based organizations to close gaps in clinical and non-clinical care
  • The PCH model, share a NYS use case, and discuss an advanced legal framework for integrating the PCH model with traditional health-care providers and value-based payment methodologies for managed care contracting
  • This legal framework must address a multitude of legal issues, depending upon the state, such as corporate practice of medicine, licensure of “intermediary organizations”, fee splitting, governance structures, etc

11. Artificial Intelligence/Machine Learning and the Health Care Industry: A Case Study in Regulatory, Privacy, Health Care Disparities, and Liability Risks and Implications
Sarina D. Rivera
Mildred Segura
Sheea Sybblis

  • AI/ML technologies are currently and increasingly being used in the health care and life sciences, including in diagnostic algorithms, health care apps, pharmaceuticals and medical devices and the emerging trends on the horizon
  • Despite the rapid advancement of technology, regulations lag behind and existing regulatory frameworks are ill-suited for AI/ML, but AI-specific frameworks have been proposed
  • FDA is approaching the development of a regulatory regime that is tailored to AI/ML-specific issues
  • Concerns remain regarding how patient data will be protected as AI/ML use becomes more prevalent and the health care disparities posed by AI
  • Significant legal issues arise when developing and using AI/ML technologies, such as whether technology is practicing medicine, product liability implications, data privacy, bias, and health care disparities
  • Entities developing and using AI/ML technologies can use best practices and risk mitigation strategies to protect against potential legal liability

18. Racial and Gender Disparities in Health Care: The Role of Legal Counsel in Leveling the Playing
Elizabeth Connolly, RN, JD
Ann K. Ford, BSN, JD

  • History of racial and gender-based disparities in health care - how did we get here and why is it important?
  • Specific past and current examples of health care disparities and the impact on quality of patient care, population health and outcomes
  • Legal, compliance, reputation, and other risks that this presents to patients, providers and organizations
  • How does this issue impact reimbursement, EMTALA claims, patient rights, and more? Data on life expectancy disparities in a large urban area in diverse areas less than 5 miles apart.
  • Assessing the landscape of health care disparity in a given organization
  • Tips and tools to identify gaps and prioritize actions
  • How do we change? Sample policies, procedures and processes to address issues of racial and gender-based health care disparities
  • Specific ways that attorneys can assist in decreasing and eliminating the impact of these disparities Sustaining the change:
    • Advice and reporting to the Board: Legal counsel can facilitate the board's execution of its oversight role; how in house and outside counsel can guide the board; examples for best practices for attorneys in reporting to the board on racial and gender health care disparities
    • Auditing and monitoring processes implemented
    • Moving forward - getting to health care equality for all

29. The Terrible, Horrible, No Good, Very Bad Year: How Did We Do and Where Do We Go From Here? Understanding the Strides and Obstacles to Diversity and Inclusion Through the Lens of COVID
Komal Chokshi
Andrea Ferrari
Clevonne ("Vonne") Jacobs

The COVID-19 public health emergency brought labor, economic and social challenges throughout the world, but particularly in health care and the industries service healthcare. Historically, these types of challenges have disproportionately affected members of certain vulnerable populations, sometimes exacerbating the source social and economic issues. This panel will examine:

  • How COVID-19 played out in our industry
  • How initiatives for diversity and inclusiveness may have changed its course (and what role legal departments played in them)
  • How we are better or worse for the outcome
  • How we may do better going forward

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Fraud and Abuse

7. Stark Law Reform: Shift from Volume to a Value-Based World
Troy Barsky
Kimberly Brandt

  • Stark Law Reform: Why the changing healthcare industry compelled CMS to make needed reforms to this important fraud and abuse law
  • Exploration of the key changes to the Stark Law: Value-based payment exceptions, Bright-Line Standards for Regulations including the big three definitions: “Fair Market Value,” “Commercial Reasonableness,” and “Volume and Value”
  • Real world examples: Exploring potential value-based payment arrangements and how these laws will allow or prohibit innovation
  • Compliance guidance: Practical solutions and advice for providers that are seeking to ensure compliance in this changing regulatory landscape

13. Deep Dive: Stark and Antikickback Statute Compliance in Hospital / Physician Transactions
(See Business Law and Governance for full description)

23. Hot Topics in Fraud and Abuse
Robert Salcido
Michael Granston
Susan Edwards

  • When can opinions be “false” for purposes of the False Claims Act?
  • When can sub-regulatory guidance, such as CMS Manuals, serve as the foundation of an FCA action?
  • If defendants have a reasonable interpretation of ambiguous rules and there is no official governmental guidance to warn defendants away from that interpretation, can FCA plaintiff establish the FCA’s knowledge element?  
  • Can alleged false statements be material if the government is aware of the alleged infraction and does not seek to recoup paid claims or seek administrative sanctions other than repayment?
  • During the public health emergency, CMS has expanded payment for telehealth services and HHS has implemented other flexibilities to facilitate telehealth; what, if any, lessons learned are there to date?
  • How did OIG amend the safe harbor regulations in the “Regulatory Sprint to Coordinated Care” final rule?

34. Get Your Group in Order: Ensuring Group Practice Compliance with the Physician Self-Referral Law
(See Compliance for full description)

38. Everything You Wanted to Know About Federal Investigations But Were Afraid to Ask
Miranda Hooker
David S. Schumacher
Amanda P.M. Strachan

This session will cover cutting-edge issues in investigations, including:

  • How the government works with relators during an investigation
  • Joint defense considerations, including the contours and enforceability of joint defense agreements, how/whether to discuss these arrangements with the government, and what information can be shared with the government
  • The importance of providing clear Upjohn warnings to employees at the outset of an interview in an internal investigation, and the ramifications of not doing so
  • The various methods the government uses for obtaining information (search warrant, subpoena, CID, administrative request) and defense considerations based on the vehicle used
  • The pros and cons of agreeing to a voluntary proffer with the government
  • The government's use of parallel investigations (civil and criminal, federal and state), and what these arrangements mean for defendants
  • Who potentially has exposure in an investigation (including vicarious and successor liability)

V. The Patient Engagement and Support Safe Harbor and Independent Charity Approaches to Helping Patients
Timothy Blanchard
Jennifer E. Michael
Heather Westphal

  • New and evolving compliance tools for providing beneficiary support
  • Independent charity patient assistance programs vs. direct patient assistance
  • The Patient Engagement and Support Safe Harbor (“PESSH”): What it is and what it isn’t
  • The Value-Based Framework for the PESSH: Not as necessarily onerous as you think
  • PESSH-Specific requirements and limitations: New terminology and analysis
  • Evaluating potential scenarios

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Health Care Liability and Litigation

4. Immediate Suspension Orders: DEA and Registrant Perspectives
Gerald C. Canaan, II
Paul A. Dean

  • The DEA’s use of Immediate Suspension Orders. What are ISOs and when are they used? What is the difference between an ISO and a Show Cause Order?
  • The procedural strategies for responding to an ISO administratively or in Federal Court, including the possibility of Temporary Restraining Orders. What are the options for the Registrant and how will the DEA respond?
  • The practical consequences for the Registrant: How to coordinate parallel licensing, civil, or criminal investigations? Strategies for communicating with the DEA, DOJ and other government agencies. How will the ISO affect the business of the Registrant?
  • Settlement: What are the options for settling the ISO? Settling all civil and criminal investigations? Is a global settlement possible? If so, how is that accomplished and what are the typical terms and conditions?

10. Where Quality Meets Research: Emerging Strategies, Opportunities, and Risks of Integrated Clinical Records
Christi Braun
Rebecca M. Schaefer

  • Emerging strategies of how data being developed by providers, clinically integrated networks, and others can support quality improvement activities
  • Understanding and avoiding unintended consequences with the use of that data, such as the risks and consequences of engaging in “research” with integrated data records
  • Common “real world” data use challenges created by uses of these new and broader data sets, including when generated from an integrated clinical record
  • Practical strategies and best practices for managing consents, contractual rights and expectations of providers and patients related to these uses of data in an integrated clinical record
  • Opportunities and implications associated with leveraging clinical data and integrated records for the creation and commercialization of artificial intelligence (AI) products

11. Artificial Intelligence/Machine Learning and the Health Care Industry: A Case Study in Regulatory, Privacy, Health Care Disparities, and Liability Risks and Implications
(See Diversity for full description)

23. Hot Topics in Fraud and Abuse
(See Fraud and Abuse for full description)

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Health Information Technology

11. Artificial Intelligence/Machine Learning and the Health Care Industry: A Case Study in Regulatory, Privacy, Health Care Disparities, and Liability Risks and Implications
(See Diversity for full description)

26. Masterclass in Digital Health Technologies and Emerging Legal Issues
Suzanne Y. Bell
Stephen Evans
Ryan S. Johnson

  • Key digital health technologies and recent advancements - IoT, artificial intelligence and machine learning, remote sensors, digital therapeutics, and telemedicine
  • Advanced digital health legal issues -data rights, privacy and security, FDA, interoperability and information blocking rules, intellectual property, liability, reimbursement
  • Best practices for lawyers in advising on the development, acquisition and  use of digital health technologies
  • Aligning legal advice with client's digital health strategy

27. Evolving Enforcement and Regulatory Trends in Telehealth
Karen Corbett
Nicole A. Liffrig Molife

  • Staying ahead of telehealth government enforcement actions
  • Navigating the complex regulatory requirements in a heightened enforcement landscape at both a federal and state level
  • Managing compliance and regulatory risks when the regulatory regime
  • Compliance best practices, operational safeguards and practical take-aways

35. Developing and Sustaining Telemedicine Programs in a Dynamic Environment-- Regulatory and Practical Perspectives on Standing Up a Telehealth System
Alexa B. Kimball, MD, MPH
Adam Haynes Laughton

  • Legal background of Telemedicine
    • Quick review of major federal and state telehealth
    • COVID-19 related legal changes associated with telehealth
  • Practice aspects of establishing a telemedicine program
    • Choosing platforms/technologies
    • Space and equipment
    • Developing organizational structure
    • Training, quality and safety
    • Evaluating success
  • The future of telehealth

39. Managing Your Cybersecurity Incident Response:  Tales from the Trenches
Sherri Davidoff
Peter Enko
Meghan O’Connor

  • Practice makes perfect: The importance of developing and training on your organization’s cybersecurity incident response plan
  • Calling in the troops: When and how to engage forensics investigators and legal counsel
  • Blending the notes: How to harmonize HIPAA and state/federal breach notification obligations

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Hospitals and Health Systems

19. Case Study - How to Align Incentives and Achieve Coordinated Care in the Post-Pandemic World
Albert ("Chip") Hutzler
Stewart Kameen
Trestney Manning

In this session, we will use a series of hypothetical case study examples as a tool to explore the following important topics:

  • Coordinated care as envisioned in the pre-pandemic “regulatory sprint”
  • Aligning incentives of stakeholders in the post-pandemic world
  • How the pandemic has affected the nature of care provided, including the setting, patients, providers and outcomes
  • How the pandemic has affected the economics of care provided, including payment models, compensation models, incentive models and expected savings
  • Challenges faced by different stakeholders – patients, hospitals, physicians, advanced practice providers, third party payors, pharma industry, and others

20. Inappropriate/Unprofessional Physician Conduct: Why It Happens and How to Address It from the Peer Review, Clinical, and Employment Perspective
Alexis L. Angell
Elizabeth Grace, M.D., FAAFP
Amy F. Shulman

  • Inappropriate/unprofessional conduct - What is the issue? What should Hospitals look for?
    • Boundary violations in the practice of health care including, but not limited to, sexual misconduct, drug diversion, dual relationships, and prescription of controlled substances to non-patients
    • Privacy and respect violations
    • Misrepresentation, falsification of credentials, or failure to disclose
    • Financial or billing irregularities
    • Disruptive behavior and communication issues
    • Failure to adequately inform patients in obtaining consent
  • Misuse of social media or electronic medical records
  • Failure in supervisory roles
  • How a Hospital should respond when it has identified inappropriate/unprofessional
  • Conduct (due process and investigation) - What do we do now?
  • Why we see inappropriate/unprofessional conduct - How did we get here? How did the physician get to this point?
  • How can the physician be rehabilitated - How can we help the physician? What are our options? How can we address the issues and support long-term change?
  • How a hospital can support the practitioner going forward - How do we help the physician going forward?

31. Life After the Public Health Emergency (PHE)
Lisa Vandecaveye
Cindy Wisner

  • What is the Public Health Emergency (PHE)?
  • What happened during the PHE from the perspective of The Joint Commission?
  • What happens (or happened) after the PHE and what are the “hot” quality and patient safety topics?
  • What has changed for a health care organization during the PHE in the areas of fraud and telemedicine?

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Labor and Employment

36. Looking Forward: Employment Law Under the Biden Administration
Rachel Freyman
Mark E. Tabakman

The new Biden administration brings with it a new focus and new support for numerous legislative and regulatory proposals and policies that are poised to significantly change the employment and labor law landscape for health care providers for years to come. In this session, we will cover:

  • Initiatives the Biden administration is likely to prioritize and the impact of those on employers, including new paid leave, the broadening of discrimination protections, the expansion of wage and hour protections, and the strengthening of pro-union legislation
  • New administration appointments and how those appointees will influence policy changes
  • Trends in employment litigation nationally, including class actions, that affect the bottom line

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Legal Ethics

6. Legal Ethics in a Pandemic: Lawyer vs. Ethicist
Joanne (Jody) E. Joiner
Teresa Williams

The interplay between legal and ethical concerns has never been more significant as it has during the COVID-19 pandemic. The scarcity of resources such as hospital beds, ventilators, ECMO machines, and clinical staff has created challenging scenarios that are significantly more complicated than the typical end-of-life issues typically addressed at hospitals.  This program will cover:

  • The role of attorneys on biomedical ethics committees of hospitals
  • Rules of Professional Conduct - 1.3, 1.4, 1.7, 1.14, 7.1
  • Creation and operation of a hospital COVID-19 ethics committee
  • Sample method of making decisions regarding scarce resources during a pandemic
  • Comparison of case studies:
    • Typical end-of-life scenarios
    • COVID-19 end-of-life scenarios

22. Legal Ethics Considerations of Conducting Privileged, Crisis-Response Investigations of Health Care-Related Cyberattacks
Dawn Crumel
Todd Presnell

It’s no secret that perpetrators of ransomware, malware, and a myriad of other cyberattacks increasingly target health care providers, payors, and others warehousing confidential and protected patient information. How the corporate victims immediately respond to these crises presents a variety of potential adverse consequences, including creating evidence that may become discoverable in the inevitable third-party actions and government inquiries. In this presentation, the speakers will discuss:

  • Establishing and maintaining privilege and work-product protections
  • Practical tips for avoiding a second liability from the cyberattack
  • Best practices for conducting an investigation with forensic and other experts

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Life Sciences

4. Immediate Suspension Orders: DEA and Registrant Perspectives
(See Health Care Liability and Litigation for full description)

15. Hot Topics in Pharmacy Law and Pharmaceutical Supply Chain
Lindsay Holmes
Roger N. Morris

  • Recent DEA changes and proposals impacting pharmacies and other registered entities
  • COVID 19 impact of drugs supply chain
    • Drug shortages
    • Vaccine administration
  • DSCSA (federal track and trace) implementation
  • Updates related to the opioid crisis
  • Telemedicine updates in the pharmacy space
  • PBM Updates
    • Rutledge v. PCMA and its potential impact of PBMs and the pharmaceutical supply chain (ERISA pre-preemption case related to state laws regulating PBM drug reimbursement rates)
    • State law changes

40. Partnering with Life Sciences Companies in a Value-Based World
Mike Dreyfuss
Eric Greig

  • Enforcement focus on rebates provided by life sciences companies
  • Navigating value-based purchasing and outcomes-based rebates
  • Key compliance and regulatory considerations, including recent developments
  • Compliance best practices, operational safeguards, and practical take-aways

41. Vaccine Successes and Challenges During the Pandemic: Looking Forward With Hope from the Provider, FDA, and Phrma Perspectives
Richardae Araojo
Michelle Johnson Tidjani
Sharon Lamberton

  • “Year in review” of how the industry took important steps when the pandemic was declared, including collaboration with the private sector and other stakeholders around the world
  • Status of the clinical trials underway for both vaccines and treatments, the complexity of research for vaccine development and how the industry is working in partnership with other companies on manufacturing
  • The work of the Office of Minority Health and Health Equity during the pandemic, including multiple resources currently available (e.g., videos, social media and healthcare provider toolkits, and more)
  • The importance of educating communities of color and providing accurate information to advance health equity 
  • Successes of the provider community during this pandemic and the ongoing challenges associated with the vaccination efforts

III. State and Federal Regulation of PBMs: ERISA Preemption and PBM Policy Post-Rutledge
Kristyn B. DeFilipp
Urmila Paranjpe Baumann

This session will provide a comprehensive review of the changing landscape for the regulation of pharmacy benefit managers (PBMs), including:

  • An overview of federal law limitations on state regulations including the ERISA and Part D preemption doctrines
  • History of ERISA preemption jurisprudence, notably, the Supreme Court’s recent decision in Rutledge v. PCMA
  • The possible impact of Rutledge on state laws that impact health plans, drug prices, and PBMs
  • Other recent efforts to regulate the relationships between PBMs and health plans, beneficiaries and pharmacies, including the federal rebate rule

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Long Term Care

21. Hospices and Long-Term Care Facilities: Synergy and Conflict with COVID and Beyond
Melissa Crothers
Emily M. Park

  • Hospice fundamentals as regards provision of hospice services in the long-term care setting (contracting, reimbursement and regulation)
  • The unique impact of COVID-19 on hospice services in long-term care facilities
    • Limitation of entry for outside vendors and use of telemedicine
    • Skilling hospice patients returning from the hospital
  • Risk areas for hospice services in nursing facilities
    • Anti-kickback and the overlap between the two services
    • Scope creep in assisted living facilities
    • Preferred provider arrangements
  • Non-hospice palliative care services for long-term care residents
  • Nursing facilities operating their own hospices

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Medical Staff, Credentialing, and Peer Review

32. The Lure of Distant Shores: The Legal Implications of Using Overseas Contractors
Daniel Shay

This session examines the use of overseas contractors in health care, both for clinical services (e.g., "nighthawk" radiology) and administrative services (e.g., billing, coding, and transcription). The session will address:

  • The types of overseas services used by health care providers, and why they are attractive to them
  • Medicare's prohibition on overseas clinical services
  • State law implications for overseas clinical services, such as licensure/certification restrictions and supervision requirements
  • Medicare and Medicaid restrictions on the use of overseas administrative contractors, such as Medicare Advantage requirements surrounding first-tier, downstream, and related entities
  • HIPAA implications in the use of overseas administrative contractors, including the OCR's statements regarding overseas storage of PHI, and the legal risks posed to covered entities using contractors or subcontractors from overseas
  • Contractual provisions to address the use of overseas contractors

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Payers, Plans, and Managed Care

17. The No Surprises Act: What to Expect and How to Comply
Eric Chan
Wendy Soe-McKeeman

  • Key provisions of the new federal No Surprises Act, effective Jan. 1, 2022, including a look at its legislative history and rationale
  • Keys to complying with the new law, with a focus on streamlining compliance with the new federal law and its state law equivalents
  • How the No Surprises Act interacts with existing state law surprise billing regimes.
  • Lessons learned by health plans and providers who have faced similar surprise medical billing laws in New York and California, among other states

III. State and Federal Regulation of PBMs: ERISA Preemption and PBM Policy Post-Rutledge
(See Life Sciences for full description)

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Physicians

17. The No Surprises Act: What to Expect and How to Comply
(See Payers, Plans, and Managed Care for full description)

20. Inappropriate/Unprofessional Physician Conduct: Why It Happens and How to Address It from the Peer Review, Clinical, and Employment Perspective
(See Hospitals and Health Systems for full description)

30. Arbitration of Out-of-Network Billing Disputes: A Survey of Newly Adopted State Regimes
(See Dispute Resolution for full description)

34. Get Your Group in Order: Ensuring Group Practice Compliance with the Physician Self-Referral Law
(See Compliance for full description)

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Professional Development

16. Sponsorship vs. Mentorship 202 – Committing to Success
Priya Bathija
Almeta Cooper
Jennifer M. Nelson Carney
Trent Stechschulte

At last year’s Annual Meeting, we presented on why mentorship and sponsorship are crucial to success for all attorneys. This session builds on that discussion. Importantly, in the dramatic shift to remote working and physical distancing there has been an equally dramatic impact on mentoring and sponsorship, and some of that impact will remain after the pandemic given that remote working will become more common. This session focuses on practical strategies, tips and tactics attorneys can use to overcome the obvious and subtle changes to these relationships in the post-pandemic world. Also, the speakers will address how to combine the benefits of both mentorship and sponsorship as attorneys navigate their careers. A majority of the time will be devoted to diving into the nuts and bolts of these relationships, including concrete steps to take while serving in each of these roles. In addition to practical tips and tactics, speakers will share their own real-life experiences of serving as sponsors, protégés, mentors and mentees, including to each other.

  • Share the difference between mentorship and sponsorship
  • Learn strategies for overcoming the challenges of building relationships with mentors and sponsors while remote working and physical distancing
  • Go deeper to learn how mentorship and sponsorship can be used together as a powerful tool to advance and navigate an attorney’s career
  • Learn practical tips and tactics that can be used to build and grow successful mentorship and sponsorship relationships, including the do’s and don’ts for serving as a sponsor, protégé, mentor or mentee

I. Using Mindfulness to Help Address Attorney Burnout and Stress, Mental Health Challenges, Substance Use Disorder, or Cognitive Impairment
Scott Bennett
Gerard M. Nussbaum

  • Growing recognition by the legal profession of attorney stress, burnout, and mental health challenges, which may manifest via cognitive impairment, substance abuse, and adverse behaviors
  • How a mindfulness practice may support an attorney in
    • Meeting duties under the Rules of Professional Conduct
    • Avoiding burnout, substance abuse, and cognitive impairment
    • Enhancing job performance and overall wellness
    • Improving mental health and resiliency
  • Practical suggestions, tips, and resources for starting and maintaining a mindfulness practice
  • Brief mindfulness exercises will be included

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Public Interest

14. Ensuring Mental Health Parity During and after a Pandemic
(See Behavioral Health for full description)

18. Racial and Gender Disparities in Health Care: The Role of Legal Counsel in Leveling the Playing Field
(See Diversity for full description)

29. The Terrible, Horrible, No Good, Very Bad Year: How Did We Do and Where Do We Go From Here?
(See Diversity for full description)

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Regulation, Accreditation, and Payment

2. A Model for Building Health Equity - Addressing Social Determinants of Health through Value Based Payment
(See Diversity for full description)

3. Transforming Primary Care: Direct Contracting Entity
James M. Daniel
Clive Fields, MD

The CMS Innovation Center introduced a new voluntary payment model and has enrolled the first batch of Direct Contracting Entities (DCEs).  This session will address:

  • Background on the new payment models and financial methodologies available under Direct Contracting
  • Participation options and selection for organizations interested in DCE
  • Legal considerations for structuring and valuation of DCEs

19. Case Study - How to Align Incentives and Achieve Coordinated Care in the Post-Pandemic World
(See Hospitals and Health Systems for full description)

32. The Lure of Distant Shores: The Legal Implications of Using Overseas Contractors
(See Medical Staff, Credentialing, and Peer Review for full description)

40. Partnering with Life Sciences Companies in a Value-Based World
(See Life Sciences for full description)

V. The Patient Engagement and Support Safe Harbor and Independent Charity Approaches to Helping Patients
(See Fraud and Abuse for full description)

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Tax

33. 2021 Tax Law Update
Michael N. Fine
Gerald M. Griffith

This panel will provide updates on recent tax law developments impacting health care organizations, including:

  • Recent tax-related developments from COVID relief legislation
  • Enforcement of IRC Section 501(r) and the Community Benefit Standard
  • Excise taxes on highly-paid executives of tax-exempt organizations (IRC Section 4960)
  • Unrelated business income developments, including, the final IRC Section 512(a)(6)’s “silo” regulations

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Teaching Hospitals / Academic Medical Centers

10. Where Quality Meets Research: Emerging Strategies, Opportunities, and Risks of Integrated Clinical Records
(See Health Care Liability and Litigation for full description)

25. Managing Conflicts Across the Institution: Reducing Silos to Mitigate Risk
(See Compliance for full description)

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Continuing Education for the Annual Meeting

Sessions covering beginner to advance, including ethics, will offer you the opportunity to obtain your CLE, CPE, and CCB credits from AHLA. The number of credits being offered will vary.

Learn More

What is a Virtual Program?

Technology allows us to connect in a powerful way. Since we are unable to travel, we are hosting a virtual conference to bring the profession together to meaningfully share and learn from each other. 

Learn More