Schedule

Sunday, November 7, 2021

Monday, November 8, 2021

8:00-8:15 am
Welcome and Introductions
Michael E. Paulhus, Program Planning Chair

8:15-9:00 am
1. Health Law in 2021 and Beyond: Top Trends, Challenges, and Opportunities
Asha B. Scielzo

  The pandemic: What’s next?
  Digital health and the role of technology: Telehealth, AI, and Beyond
  Disparities in health care
  Health care data, privacy & security
  Fraud and abuse
  Transactions
  Compliance

2. The Basics of Medical Coding for Health Care Lawyers 
(not repeated)
Robert A. Pelaia

• The basics of procedural (CPT) coding
• New 2021 Evaluation & Management (E&M) codes
• Diagnosis (ICD-10) coding
• Guidance on use of the CPT & ICD coding manuals

3. Telehealth – Soup to Nuts​
Allison M. Cohen

• Telehealth regulatory framework
  • Telehealth Regulations 101- where to look, who is the regulator, what is regulated?
  • What temporarily changed during COVID-19?
  • Which regulations remain in place?
• Key considerations when reviewing telehealth arrangements
  • Reimbursement
  • Professional board requirements/licensure/scope of practice
  • Fraud and abuse considerations
  • Corporate Practice of Medicine
  • Privacy
• Insights into telehealth compliance and enforcement
  • Recent regulations and rulemaking
  • OIG and DOJ enforcement trends

4. Hospital Medical Staffs: Fundamentals, Trends, and Emerging Issues
(not repeated)
Alexis L. Angell
Brian C. Betner

• Applicable statutes, regulations, and accreditation requirements for hospital medical staffs
• Underlying legal, business and operational issues for hospital medical staffs
• Emerging issues and areas of emphasis, including:
  • Medical staff/employed physician considerations at hospitals
  • Integrating non-physician Advanced Practice Professionals
  • Information sharing
  • Trends in Medical Staff governance and oversight
  • Drafting tips and sample language for hospitals

5. HIPAA for New Practitioners
Marilyn Lamar

• Introduction to HIPAA, including the basics of the HIPAA Privacy, Security, and Breach Notification Rules
• Steps for implementing a HIPAA compliance program for covered entities and business associates
• Deeper dive into the HIPAA Security Risk Analysis requirement
• Recent HIPAA enforcement actions and OCR auditing practices

6. Fundamentals of Health Care Professionals: Understanding Professional Scope of Practice, Reimbursement and Private Equity Investment Considerations in Practice Transactions
(not repeated)
Melesa A. Freerks
Alex T. Krouse

MD, DO, DNP, DDS, DPM, DPT, and more. The alphabet soup of health care professionals providing care across the country is less than clear. In addition, the unique laws and scopes of practice of these professionals can further create confusion. This presentation will provide you with an in-depth understanding of various health care professionals delivering care across the country. Legal analysis of services provided by physicians, advanced practice nurses, physician assistants, and other non-physician practitioners including the differences and similarities of these health care professionals:

• The relevant legal issues for each professional such as licensing, scopes of practice, and collaboration/supervision issues
• The billing structures and requirements for each of these health care professionals
• Corporate practice of medicine laws and other related regulatory structures
  • Preparing for and structuring the private equity transaction in light of regulatory restrictions
• A case study analysis of how these individuals function in a legal and compliant manner within healthcare organizations across the country

7. It’s a Managed Care World (We’re just living in it)
A. Joel Richlin

• Commercial insurance and managed care contracting:
  • Key concepts in commercial insurance (e.g., HMOs vs. PPOs, Exchange plans, and ERISA plans)
  • Key concepts in out-of-network reimbursement including the new Federal No Surprises Act (effective 1/1/21)
  • Key concepts in managed care contracting (e.g., reimbursement methodologies, steerage, billing requirements, appeal requirements, provider manual obligations, and alternative dispute resolution clauses)

8. Good Behavior: What Every Health Lawyer Needs to Know About Behavioral Health​ 
(not repeated)
Michaela D. Poizner

• What does “behavioral health” include? Take a tour of the industry segments, care settings and provider landscape
• What is the defining legislation shaping the behavioral health community? Learn about must-know laws governing behavioral health stakeholders
• What legal challenges are unique to behavioral health providers? Get an overview of fraud and abuse, privacy, and other laws that apply specifically to mental health and substance use disorder treatment providers
• What’s hot in behavioral health? Get familiar with trends in behavioral health transactions (private equity!), the influence of digital health (telemedicine!), and changing reimbursement models (value-based payment!)

9. Compliance Program Design and Effectiveness​
Andi Bosshart
Ritu K. Cooper

• Government expectations concerning compliance program design and effectiveness
• The fundamental 7 elements of a compliance program and other emerging compliance expectations
• Board oversight of the compliance program
• Cutting-edge concepts and best practices designed to increase compliance program effectiveness
• Anticipated health care compliance risk areas for 2022
• Key takeaways

10. The ABCs of the PSL: A Primer on the Physician Self-Referral Law​
Nicholas F. Alarif
Lisa Ohrin Wilson

• An introduction to the Physician Self-Referral Law (PSL), including its legislative and regulatory history
• Key terminology of the PSL
• Exceptions to the PSL’s prohibitions and how to use them effectively
• PSL precautions and practitioner tips

Tuesday, November 9, 2021

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

11. Antikickback Statute and False Claims Act
Marissel Descalzo
Bethany L. Rupert

  Recent health care fraud and abuse enforcement actions and trends, such as the CARES Act, telemedicine, nursing homes, anti-trust, and genetic testing
  The Anti-Kickback Statute
  The False Claims Act and Recent Developments
  Practical tips for how to respond to a False Claims Act and/or Anti-Kickback Statute investigation
  Practical tips on how to respond to a Civil Investigative Demand
  Proactive compliance considerations

12. The Fundamentals of a Health Care Transaction
Vida C. Harvey
Thomas Spellman

  Different types of transaction structure for a health care deal (e.g., asset purchase versus stock purchase or merger)
  A framework for approaching due diligence in a health care transaction
  Regulatory and legal issues common to health care transactions (e.g., federal Anti-Kickback and Stark Laws; anti-trust issues; and tax-exempt issues)
  The importance of the concepts of “fair market value” and “commercial reasonableness” to a health care transaction
  Apply these strategies to a case study (physician-hospital integration), sample letter of intent, and sample due diligence checklist to understand how various factual scenarios could affect the transaction and to highlight diligence and transactional considerations

13. Fundamentals of Labor and Employment in a Global Pandemic​
(not repeated)
Rufino Gaytán

• Continuing impact of COVID-19 in the workplace, including OSHA’s Emergency Temporary Standard, mandatory vaccination policies, religious and disability accommodations, and related risk mitigation strategies
• Labor law (NLRB) developments, including potential upcoming changes driven by the new NLRB General Counsel and a new Democratic majority
• Impact of a competitive job market on the terms and conditions of employment, including discussion of restrictive covenants, employee satisfaction and strategies to address these and related issues

5. HIPAA for New Practitioners
(repeat)
Marilyn Lamar

• Introduction to HIPAA, including the basics of the HIPAA Privacy, Security, and Breach Notification Rules
• Steps for implementing a HIPAA compliance program for covered entities and business associates
• Deeper dive into the HIPAA Security Risk Analysis requirement
• Recent HIPAA enforcement actions and OCR auditing practices

14. Representing Physicians and Physician Practices and Navigating the Options that Exist
(not repeated)
Lisa M. Gora
Kim Harvey Looney

• Anatomy of a Physician Employment Agreement and the salient provisions to understand
• State and federal regulatory issues: Corporate practice of medicine, Anti-Kickback and fee-splitting, among others
• Physician and Hospital Alignment versus Private Equity: Degrees of integration versus private equity structures and the management services organization model
• Most common alignment mistakes
• Telehealth: Where has it been and where is it going?

15. Fundamentals of Long Term Care
(not repeated)
Randall R. Fearnow

• The scope and importance of long term care
• Unraveling the levels of institutional long term care
• Introduction to home care and hospice.
• Medicare, Medicaid, and third party reimbursement
• The state/federal survey process
• Infection control-lessons learned from Covid-19
• Alternative Care Models in Post-Acute

16. Fundamentals of Public Health Law
(not repeated)
Montrece McNeill Ransom
Brian A. Smith

• How government structures shape public health infrastructure and legal preparedness
• How health care attorneys can advance health outcomes and equity by complying with public health laws
• Fundamental and developing areas of public health law, including public health emergency powers, public health surveillance, legal epidemiology, and racism as a public health issue 
• Examples of changes in state public health authority since COVID-19

7. It’s a Managed Care World (We’re just living in it)
(repeat)
A. Joel Richlin

• Commercial insurance and managed care contracting:
  • Key concepts in commercial insurance (e.g., HMOs vs. PPOs, Exchange plans, and ERISA plans)
  • Key concepts in out-of-network reimbursement including the new Federal No Surprises Act (effective 1/1/21)
  • Key concepts in managed care contracting (e.g., reimbursement methodologies, steerage, billing requirements, appeal requirements, provider manual obligations, and alternative dispute resolution clauses)

3. Telehealth – Soup to Nuts
(repeat)
Allison M. Cohen

• Telehealth regulatory framework
  • Telehealth Regulations 101- where to look, who is the regulator, what is regulated?
  • What temporarily changed during COVID-19?
  • Which regulations remain in place?
• Key considerations when reviewing telehealth arrangements
  • Reimbursement
  • Professional board requirements/licensure/scope of practice
  • Fraud and abuse considerations
  • Corporate Practice of Medicine
  • Privacy
• Insights into telehealth compliance and enforcement
  • Recent regulations and rulemaking
  • OIG and DOJ enforcement trends

9. Compliance Program Design and Effectiveness
(repeat)
Andi Bosshart
Ritu K. Cooper

• Government expectations concerning compliance program design and effectiveness
• The fundamental 7 elements of a compliance program and other emerging compliance expectations
• Board oversight of the compliance program
• Cutting-edge concepts and best practices designed to increase compliance program effectiveness
• Anticipated health care compliance risk areas for 2022
• Key takeaways

On Demand Offerings (Available Monday, November 1)​

The sessions below are included with the In-Person registration and are not sold separately. The On Demand sessions will be available to watch prior to the In-Person event.

I. Medicare A and B
Allison R. Hollender
Felicia Y. Sze

• Medicare Governance: CMS and Medicare Contractors
• Part A coverage and reimbursement
• Part B coverage and reimbursement
• How Parts A and B impact beneficiaries and providers/suppliers
• Medicare Enrollment and Certification–How to do it and what to be aware of
• Conditions of Participation and Payment–What you need to do to maintain enrollment and get paid
• Medicare Impact on Health Care Transactions–How does Medicare impact health care transactions: CHOW/asset purchase v. CHOI/equity transfer
• Keeping Medicare updated re provider changes
• How to assist providers address Medicare questions–Where to research and how to interpret guidance
• Brief COVID Medicare updates

II.  Fundamentals of Medicare Parts C and D​
David E. Kopans

• Insurance and managed care regulation
• Medicare Managed Care Programs
• Medicare Part C (Medicare Advantage)
• Medicare Part D (Prescription Drug Benefit)
• Survey of MA-PD operational matters

III. Medicaid – Still the One: An Examination of Medicaid Fundamentals and its Critical Place in the American Health Care System
Caroline Farrell
Jeff J. Wurzburg

• A brief history of the Medicaid program and its program objectives
• The statutory requirements for Medicaid programs
• The ongoing impact of Medicaid during the COVID-19 pandemic
• Different state approaches to Medicaid and Medicaid eligibility
• The future of the Medicaid program the Biden Administration’s approach to the program

IV. Recent Developments in Antitrust All Health Lawyers Should Know​
Kevin Hahm
Kara B. Kuritz
Katharine O'Connor

This presentation will provide a synopsis of recent events in antitrust law affecting all participants in the health care industry, with a focus on health care providers and life sciences companies. Key areas of discussion will be:

• Increased antitrust scrutiny in health care labor markets
• Increased federal and state antitrust scrutiny of M&A transactions, and the enactment of state premerger notification regimes
• Private and government litigation, particularly in the monopolization space
• Biden Administration priorities and implications for the future
• Criminal antitrust activity against healthcare and life sciences companies and executives

V. Some Things You Should Know About Tax Exemption as a Health Lawyer​​
Michael N. Fine

• The basics of Section 501(c)(3) status
• Varieties of tax-exempt health care organizations
• Understanding foundations status
• Community benefit and Section 501(r) standards
• Obtaining and maintaining tax-exempt status
• Avoiding inurement and excess benefit transactions
• Minimizing unrelated business income tax
• Interacting with the IRS

VI. Fundamentals of Health Care Valuation for Lawyers
Christi J. Braun
Christina C. Street

• Why "Fair Market Value" matters - brief discussion of the overarching concept and the rationale behind it.
• Brief history of the Fair Market Value standard (including IRS Revenue Ruling 59-60 and related guidance)
• Stark/Anti-kickback Fair Market Value definition, including recent changes to the Big 3 definitions and related regulatory guidance, and recent case law (and major settlements)
• COVID-19 and its impact on FMV and data used to determine FMV
• Basic valuation principles and approaches, including the cost, income, and market approaches, as well as basic valuator standards and requirements
• Common recurring problems in health care valuation (including data issues and the distinction of "commercial reasonableness" and "volume or value" standard)
• Basic examples of valuation situations, including process of data gathering, analysis and documenting the appraisal

VII. Lawyers, Docs, and Money: The Health Care Lawyer’s Guide to Legal Ethics in Physician Transactions​
Anjali B. Dooley
William W. Horton

• The legal ethics framework for advising clients on Stark, Anti‐Kickback, and similar knotty issues
• Duties when the law isn’t clear... or when it’s too clear
• The numbers game: The lawyer’s role in dealing with fair market value and commercial reasonableness issues
• Walking back the cat: Can this deal be saved… ethically?
• Enlightened self‐interest: Staying out of trouble while helping your client do likewise

VIII. Sponsorship vs. Mentorship: Why You Need Both to Succeed​
Priya Bathija
Almeta E. Cooper
Jennifer M. Nelson Carney
Trent Stechschulte

There has been significant discussion in the legal field about sponsorship, mentorship and why both are critical to success for all attorneys. In this session, speakers will provide a primer on the difference between mentorship and sponsorship and the role of mentees, mentors, sponsors and protégés. In addition, speakers will discuss the benefits of having a sponsor and mentor as an attorney practicing in a variety of settings and how each can impact an attorney’s career development. They will share their own real-life experiences serving as sponsors, protégés, mentors and mentees and share strategies they have used to foster and grow these relationships throughout their careers.

• The differences between sponsorship and mentorship and define the roles of a sponsor, protégé, mentor and mentee
• The benefits of having both mentors and a sponsors throughout an attorney’s career
• Guidance for attorneys to find, build and grow these relationships
• How these relationships can change and evolve over time
• Insights about the impact of disruptive innovation in healthcare on these relationships