Physicians and Hospitals Law Institute

The timeline for the program is below. We will offer 21 in-depth sessions covering value-based health care delivery and payment, antitrust, health information technology, the impact of COVID on health care, and more. In addition, 4 sessions will be offered on demand, where attendees can watch the presentation on their own time. The difference between the a live session and an on-demand session is the live sessions include an interactive speaker/attendee question and answer feature.

Continuing education credits (CLE, CPE, and CCB) are available for the sessions being presented on February 10-12, 2021 as well as for any on-demand sessions that you watch.

Attendees can access program materials, continuing education information, and networking opportunities on the Attendee Website. This site is for attendees only and you must be logged in to access it.

View Faculty information

Wednesday, February 10, 2021

1:00-3:00 pm EST
1. Year in Review

Robert Homchick
Kristen Rosati
Michael Schaff

As usual, this will be a fast-paced overview of developments over the past year. This year, not surprisingly, we’ll focus on the significant legal developments resulting from the COVID-19 pandemic and the flood of new regulations published during the waning days of the Trump Administration. Time permitting this session will cover:

  • COVID-related legislation and Blanket regulatory waivers
  • The rise of telemedicine
  • COVID-related claims and developing immunity
  • COVID financial relief for providers and attendant risks
  • Health care reform: Significant Supreme Court decisions and status of the Affordable Care Act
  • The Regulatory Sprint to Coordinated Care and the final regulations from CMS and OIG
  • HIPAA and HIT developments: Information blocking and interoperability, OCR enforcement and data breaches
  • Transparency Rules and Reimbursement Trends
  • Fraud and abuse: The beat goes on

Thursday, February 11, 2021

11:00 am-12:00 noon EST
2. Overview of the SPRINT Rules

Julie Kass (Moderator)
Robert K. DeConti
Catherine A. Martin
Jillian Sparks
Lisa O. Wilson

  • Framework and terminology for value-based health care delivery and payment
  • New exceptions and safe harbors for “value-based arrangements”
  • Other new exceptions, safe harbors, and flexibilities
  • Policy clarifications to facilitate compliance efforts under the physician self-referral law

12:15-1:15 pm EST  |  Concurrent Sessions
3. Identifying the Strings Attached: Top Enforcement Risks from Receiving COVID–19 Government Assistance Funds

Sean Bosack
Alison B. Rousseau
Jody Rudman

  • Funding available to providers under the Provider Relief Fund of the CARES Act, how amounts were calculated, and the certifications inherent in the receipt of those funds
  • The enforcement personnel who will be utilized by the federal government to investigate claims related to wrongful receipt, keeping or use of provider relief funds
  • Statutory tools available to prosecute criminally or civilly, including the False Claims Act and various federal criminal statutes
  • Likely enforcement actions based on the historical context of the prosecutions that followed other disasters and programs such as Hurricane Katrina and the Troubled Asset Relief Fund
  • Possible actions to be taken in order to avoid, or prepare to defend, an investigation, a lawsuit or a prosecution

4. Billing Company Contracts:
The Principal Is Responsible for the Acts of the Agent
Alice Gosfield

  • What these companies do: Pros and cons
  • How they are compensated
  • Allocation of responsibilities between the parties
  • Performance metrics
  • Post termination issues
  • Medicare reimbursement rules
  • What the OIG says
  • How things go wrong
5. Pandemics, Policy Changes and Value Based Models, Oh My!

Justin Chamblee
Elizabeth Mills
Kristen McDermott Woodrum

  • The current status of value based models-what’s new, what’s in, what’s out, what the future may hold
  • An in-depth practical, legal and financial analysis of the impact recent events have had and/or may have on these models- COVD-19, Stark and AKS changes, CMS 2021 Final Rule
  • Real world challenges organizations face in effectively implementing value-based models and practical strategies to mitigate those challenges

1:30-2:30 pm EST  |  Concurrent Sessions

6. Demystifying the Stark Law’s Overhauled Big 3: Commercial Reasonableness, Volume or Value and FMV
Kelly Cleary
Leia Olsen
Joseph Wolfe

On January 19th new regulations went into effect aimed at modernizing and streamlining implementation of the Stark Law. The final rule that implemented the regulatory changes included extensive guidance from CMS on three critical regulatory requirements, fair market value, commercial reasonableness and the prohibition on “taking into account” the volume or value of a physician’s referrals. Notably, CMS proposed modifications to the fair market value definition, a new definition for commercial reasonableness and a bright-line standard for circumstances where compensation will be considered to “take into account” the volume or value of referrals. Our session will provide insight into the Big 3 and how the new guidance will impact health care contracting, compliance strategies and future enforcement priorities, including the following:

  • The reorganized FMV standard and important examples from the commentary
  • The new commercial reasonableness definition and clarifications from CMS regarding losses
  • The objective volume/value test and new guidance on directed referrals
  • The potential impact on physician arrangements, compliance strategies and enforcement

7. Hot Topics and Best Practices in CMS Administrative Litigation
Bradley Humphreys
Brian Stimson

This session will survey recent decisions and current litigation involving the Centers for Medicare & Medicaid (CMS), and offer practical perspectives on litigation strategies in Administrative Procedure Act (APA) cases. In particular, the program will cover litigation involving:

  • CMS rules or policies on prescription drug reimbursement, hospital price transparency, the outpatient prospective payment system, and reimbursement of disproportionate share hospitals
  • Local coverage determinations under Azar v. Allina Health Services, 139 S.Ct. 1804 (2019)
  • Administrative recoupments or offsets of alleged overpayments
  • Changes in agency policy following changes in presidential administrations

8. The Digital Imperative – Accelerating Hospitals and Physicians on Path Forward After the Pandemic
Daniel Peters
Amy Stevens
Sarah Swank

As we have all experienced in our own personal lives, services are fundamentally transforming every industry such as Amazon in retail, Netflix in media, Uber in transportation and Airbnb in hospitality. Out of necessity, the pandemic is accelerating the adoption of digital health solutions nationally. We have seen an historic change in how health care is delivered from virtual triage to video visits to remote monitoring. This rapid adoption of digital is bringing new threats and opportunities to the forefront for all sectors of the health care continuum. Consumers, providers, payers, employers, venture-backed startups and global Fortune 100 companies are pursuing digital innovation efforts to transform and disrupt the health care industry. In this advanced session, we will explore the case study for digital health and discuss how hospitals and physicians can prepare for the future of health care.

  • Making the case for the digital imperative and defining what it means to be a "disruptor."
  • The emerging response to the digital imperative by provider organizations across the U.S.- from large academic health systems to small rural facilities
  • A market analysis of disruptive models and where venture capital, health systems and startups is investing, buying, sell and creating new models and technologies
  • Strategies for hospitals and physicians to mobilized digital transformation efforts, including telehealth and value-based models
  • The role of the attorney in guiding discussions and advise, including discussions of pitfalls and opportunities with business leaders and the board, such as building an effective and “right-sized” compliance program, the new Stark and Anti-kickback statute changes, the 1135 waivers and HIPAA

2:45-3:45 pm EST  |  Concurrent Sessions
9. Health Care Antitrust–Holy Cow!! Hot Topics in 2021

Dionne C. Lomax
Christine L. White

While 2020 was unusual in many ways, the level of health care antitrust enforcement stemming from state and federal antitrust regulators was unprecedented. We saw state antitrust enforcers continue to take leading roles to combat alleged anticompetitive activity by providers, while state regulatory bodies proposed various types of legislation that could have a measurable impact on the review of health care transactions in the future. The federal agencies issued long awaited guidance regarding their approach when reviewing vertical transactions, and the Department of Justice updated its guidance regarding the development and implementation of effective corporate compliance programs. If that isn’t enough, just days before the end of the year, the Third Circuit Court of Appeals–the same circuit that previously affirmed the FTC’s challenge in the Pinnacle-Hershey hospital merger case–affirmed a district court’s rejection of the FTC and State of Pennsylvania's attempt to enjoin a proposed merger between Thomas Jefferson University and the Albert Einstein Healthcare Network. This session will address these and other issues, including, but not limited to:

  • State regulatory changes and proposed legislation (New York 21st Century Antitrust Act, California SB 977 and legislation in Connecticut and Washington), and the impact on local and regional M&A activity
  • The repeal of the McCarran-Ferguson antitrust exemption for health insurance companies, and how it may impact the industry as a whole
  • Assessment of the Biden administration's likely agenda and health care antitrust enforcement priorities
  • DOJ no-poach ongoing litigation (e.g., U.S. v. Geisinger Health and Evangelical Community Hospital)
  • Analysis and reading the tea leaves on the FTC’s lawsuit to block Hackensack Meridian Health, Inc.’s proposed acquisition of Englewood Healthcare Foundation
  • The implications of the recent Blue Cross Blue Shield antitrust litigation settlement

10. Social Determinants of Health and COVID-19: What is the Fraud and Abuse Landscape Now?
Tony Maida
Vicki Robinson

  • How social determinants impact value-based health care in the current pandemic environment
  • The new final changes to the anti-kickback statute (AKS) and beneficiary inducement statute (BIS) regulations regarding patient incentive arrangements
  • Apply the regulations, OIG guidance, and COVID-19 waivers to various patient incentive arrangements, including co-pay waivers, local transportation, items of nominal value, promoting access to care, and more

11. Successfully Partnering With An Emerging Company—Challenges and Solutions
Jonathan G. Morgan
Gerard M. Nussbaum

  • Innovation and working with young companies–beyond a strategic investment
  • Potential risks and cultural challenges that may arise as part of collaborative innovation
  • Establishing a framework for innovation to support success for both collaborators
  • Contractual considerations in structuring collaborative relationship

3:45-4:30 pm EST

Interactive Networking Reception

Interact with your colleagues face to face in our facilitated small group discussions. More information on the topics will be available soon. (Pre-registration required)

Friday, February 12, 2021

10:00-10:45 am EST

Coffee and Conversations
Start the day by connecting with your colleagues over coffee (or tea). Hosted by our Practice Groups, virtual Zoom Rooms will be open based on a topic. More information on the topic will be available soon.
(Pre-registration required)

11:00 am-12:00 noon EST

12. COVID Related Policy Issues
Thomas R. Barker
Kimberly Brandt

  • Section 1135 waivers–what triggers them and what it allows the Secretary to do
  • What waivers exist, what have been made permanent, and which waivers might still become permanent
  • The Interim Final Rules with Comment and how those interact with the waivers
  • Case Studies–EMTALA and Telehealth

12:15-1:15 pm EST  |  Concurrent Sessions

13. Fair Market Value in Health Care–The Eighth Annual Year in Review: A New Stark-ly Different Post- COVID World
Kelly R. Anderson
Andrea M. Ferrari
Matthew Woods

This year’s session will address the effects of COVID-19 and related and potentially transformative regulatory changes such as the new Stark Law and Anti-Kickback Statute Final Rules and the changes in the 2021 Medicare Physician Fee Schedule Final Rule. The panel will provide a list of the “Top Ten” issues of 2021 as a context for:

  • 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, the Regulatory Sprint to Coordinated Care and related regulatory actions, developments in the Medicare Physician Fee Schedule, and effects of the COVID-19 public health emergency on compensation questions, compensation trends, and use of survey data
  • How these developments might reflect, challenge and/or affect going forward the prevailing legal perspectives and operational processes regarding hospital-physician compensation arrangements, including what to look for and how to analyze compensation
  • Practical takeaways and “things to look for” by counsel, compliance officers, healthcare executives and valuation analysts in the post-COVID era

14. #ItsMyLane: Legal & Medical Ethics When Doctors Speak Out on Public Policy
Anjali Bajaj Dooley
William W. Horton

From gun violence to abortion, from COVID19 vaccines to mask mandates, physicians feel increasing pressure to speak out on public policy issues.  At the same time, public advocacy activities may expose physicians to licensure risks, prosecution and even the threat of violence and may present professional responsibility challenges for lawyers who may be asked to help their clients in violating the law.  This session will explore current controversies around physicians and public policy, and on the professional responsibility obligations of lawyers advising them, including:

  • Potential conflicts between medical ethics and laws restricting (or requiring) physician speech
  • Legal implications of physician “activism” through social media
  • Professional responsibility issues when the client plans to break the law
  • Ethical responsibilities when the client is an activist but the lawyer doesn’t want to be

15. Mother, MUST I?: Compliance with the Information Blocking Rule
Ammon R. Fillmore
Joshua Mast
Melissa A. Soliz

  • The Information Blocking Rule (42 USC 300jj-52 and 45 CFR Part 171), including the regulatory exceptions, an advanced discussion of how health care providers may implement compliance with the Information Blocking Rule (IBR) within the context of real world situations
  • How health care providers might structure their electronic health information (EHI) practices to align with the IBR exceptions. They will "trace” multiple IBR compliance paths, starting with an EHI request and following it through the IBR analysis to its conclusion. This tracing will illustrate the breadth and scope of IBR compliance as health care providers are faced with EHI requests from patients and their designated third parties (from attorneys to third party applications), other health care providers in competitive markets, and more
  • Concrete examples of how health care providers might revise existing privacy and security policies consistent with IRB safe harbor conditions; what provisions to avoid in data sharing arrangements, service agreements and business associate agreements; how to leverage new data segmentation functionality in electronic health record (EHR) technology; and tips for incorporating processes to better manage EHI requests within the short time frames and conditions required by some IBR exceptions.
  • Takeaway best practices for a successful IBR compliance plan

1:30-2:30 pm EST  |  Concurrent Sessions
16. False Claims Act Enforcement
George Breen
Thomas F. Corcoran
Jeffrey Dickstein

This program, featuring government, defense and relator’s counsel, will discuss some of the “highlights” in False Claims Act enforcement pertinent to hospitals and physicians in 2020. We will also discuss:

  • Expectations for enforcement in 2021 under a Biden administration
  • Enforcement areas specific to physicians and hospitals
  • Recent policies, pronouncements and rules which may impact False Claims Act enforcement
  • Risk and compliance areas in focus for 2021

17. Evaluating and Executing Physician Practice Acquisitions in Today’s Market
Lara A. Flatau
Brandt Jewell

From strategic evaluation to financial and operational due diligence to transaction execution, we’ll discuss our recommended approach and key criteria. The audience will learn about current trends regarding physician practice acquisitions, strategic considerations, and operational hurdles. We will integrate industry data and information with our experience guiding these arrangements to clearly articulate the options from both a legal and operational perspective. Common pitfalls and lessons learned will also be discussed.

  • Industry trends, the impact of COVID-19, and our client-based perspectives on physician practice acquisitions
  • Structural options and models for practice acquisition and affiliation–address viable alternatives to acquisition or sale
  • Strategic considerations and implications for hospitals/health systems, investors, and provider groups
  • Key areas of due diligence from a legal, financial, and operational perspective
  • Common pitfalls and recommendations for evaluating and executing practice acquisitions

18. Regulatory and Reimbursement Issues Associated with the Integration of Telemedicine and Communications Technology-Based Services in Hospitals, Health Systems, and Physicians’ Practices During the COVID-19 Public Health Emergency and Beyond
Allison M. Cohen
Mia Olsen
Shira Hollander

  • Pre-COVID telehealth regulatory and reimbursement framework
    • Statutory/regulatory limitations on Medicare reimbursement
    • State laws, regulations, and reimbursement issues
    • Commercial coverage of telehealth services- contract governs, parity laws
    • Medical Board regulation, supervision, scope of practice and other regulatory considerations
  • Federal legislation, and CMS waivers and flexibilities issued in response to COVID-19
  • Operational considerations: Putting telehealth into practice
    • Expanding access to specialists and specialty services
    • Enhancing hospital-based services, post-acute care, reducing readmissions, and driving value-based care
    • Compliance considerations
  • The Road Ahead
    • The CY 2021 Physician Fee Schedule Final Rule
      • Expanding coverage of telehealth and communication technology-based services beyond the COVID-19 PHE
      • Clarification of payment rules for telehealth, remote services, and supervision
    • Proposed legislation
      • Congressional
      • What is happening in states (e.g., cross-cutting changes to state laws and regulations pertaining to telehealth)

2:45-3:45 pm EST  |  Concurrent Sessions
19. HIPAA Updates 

Alicia Brown
Seth Wolf

  • OCR policy updates:
    • HIPAA and COVID-19 updates
    • Notification of enforcement discretion on telehealth remote communications
    • Guidance of disclosures to law enforcement, other first responders, and public health authorities
    • Notification of enforcement discretion on BA uses and disclosures for public health and health oversight, community-based testing sites
  • OCR breach highlights and recent enforcement activity:
    • Right of access initiative
    • Recurring HIPAA compliance issues
    • Corrective action and best practices

20. Medicare Revocation and Enrollment: Concerns with Systematic Flaws in the New Revocation and Enrollment Landscape
Donald H. Romano
Andrew B. Wachler

  • Key expansions to CMS’s revocation authority
  • Effective strategies for appealing adverse enrollment decisions
  • How CMS has approached revocations during the COVID-19 pandemic
  • Due process concerns over lack of notice and opportunity to respond to the allegations underpinning a revocation

21. Negotiating Employment and Professional Services Agreements: Issues and Tips for Hospitals and Physicians
Rachel Gilbert
Catherine Kirkland
Margaret Elizabeth Player

  • Common issues that arise when hospitals and physicians negotiate employment or professional services agreements. Three points of view will be provided on the various topics: Outside counsel for the hospital, in-house counsel for the hospital, and counsel for the physician(s)
  • General legal and regulatory requirements governing these transactions, including Stark and Anti-Kickback. Insight on developing creative solutions within the legal/regulatory framework, and assessing which issues are most important to advancing the clients’ needs and creating a sustainable relationship
  • Specific topics and real world examples will address:
    • Benefits and risks of various compensation models
    • Issues to consider when there are multiple agreements among the parties, such as office space leases, medical directorships, on-call coverage agreements, etc.
    • Issues to consider when negotiating exclusive provider clauses or non-competes
    • Issues related to contract and relationship maintenance after an agreement is executed, such as subsequent amendments, renewals, monitoring of the parties’ obligations, and resolving disputes
On Demand Offerings 
(No Live Speaker Q&A available; Available for viewing starting February 10, 2021)
I. Navigating the PSQIA Privilege and Protections to Maximize Safety and Quality Improvements within Healthcare Organizations and through PSO Participation

Molly A. Huffman
Robin Locke Nagele
Andrea Timashenka

Seasoned PSQIA Attorneys and the Director of AHRQ’s PSO Division will share their insights on:

  • How state and federal PSQIA case law is shaping the design of provider patient safety evaluation systems
  • Tips for providers working with external PSOs to maximize privilege and quality/safety benefits
  • Tips for component PSOs working within a health system
  • The takeaways for providers from the HHS OIG’s report on Patient Safety Organizations: Hospitals Participation, Value and Challenges
  • The future of AHRQ’s PSO Program

II. Business Immigration Issues for Health Care Counsel

Roger Tsai
Christopher L. Wendt

  • Immigration policies that will continue from the Trump administration, including I-9 scrutiny and compliance
  • Hiring and retaining immigrant physicians, nurses, and information technology professionals moving forward in the Biden Administration
  • Immigration compliance changes employers must implement in response to COVID-19
  • How many research hospitals may qualify for H-1B visa cap-exemption, and an overview of changes in USCIS interpretation of affiliation rules
  • Tips for overcoming increased denial rates on H-1B visas for professional health care workers

III. Preventing Sex Discrimination in Health Care under Section 1557 of the ACA: A Review of Litigation and Best Practices for Compliance

Toby K. L. Morgan
Andrew C. Stevens

  • In the Affordable Care Act, Congress for the first time declared discrimination in health care on the basis of sex to be unlawful. This new prohibition may be enforced by private individuals, in class actions, by the Department of Justice, and by Office for Civil Rights at HHS
  • In light of the U.S. Supreme Court's decision in Bostock, sex discrimination under Section 1557 likely encompasses discrimination on the basis of sexual orientation and gender identity (LGBTQIA status). Sex discrimination under Section 1557 also includes discrimination on the basis of pregnancy and sex stereotyping
  • The law of sex discrimination as it has developed under Section 1557, provide concrete recommendations that hospitals and health systems may put into practice to prevent discrimination on the basis of sex, including as it relates to discrimination against LGBTQIA individuals
  • For example, hospitals and health systems should invest substantial resources into providing culturally competent care to LGBTQIA individuals. Hospitals and health systems should also take care to ensure that their policies and practices do not have an adverse disparate impact on the basis of sex so as to minimize the risk of disparate impact (unintentional) discrimination claims
  • Specific attention will also be paid to fact patterns common to litigation under Section 1557, including allegations related to mis-gendering transgender individuals, which courts have concluded is a form of unlawful harassment on the basis of sex

IV. The 2021 E/M Changes: What Attorneys Need to Know About The Impact On Physician Compensation and Coding Audit Risk

Robert D. Stone
Valerie G. Rock

  • What is changing and what is not changing in 2021
  • The resources associated with the change
  • The potential risks in the coding and potential payer perspectives
  • The changes in consideration of the 60-Day Rule, FCA, and Stark