Monday, January 25, 2021

1. Harnessing Value: A Panel Discussion on the Ongoing Response of an AMC and Major Research Institution to a Pandemic
Lori Oliver (Moderator)
Ana Anderson
John Lynch
Gerianne J. Sands

• Lessons learned from the initial response of the first US city with significant Covid exposures requiring hospitalization, particularly:
  • How UW Medicine used its resources and long-held relationships to bring together a broad spectrum of activity, from clinical care, to lab testing, to product development and data forecasting through the Institute of Health Metrics and continues to do so
  • How Fred Hutchinson Cancer Research Center began and continues its work in collaboration with NIH, other federal agencies and study product developers to optimize the use of existing clinical trial networks for the Phase III testing of COVID-19 vaccine products
• Where each organization is collectively and individually in the continuing response to the pandemic
• Key learnings for AMCs and research organizations to take forward in their ongoing role in health care delivery and research during a pandemic

Explore how the changes in Administration and the Congress could impact AMCs through policy development and legislative initiatives covering issues such as:       

• Biomedical research and its funding and regulation
• Affordable Care Act and insurance
• Medicare/Medicaid reimbursement
• Telehealth and other care models
• Regulatory changes and enforcement priorities

• Federal/CMS telehealth-related waivers and flexibilities issued in response to COVID-19 that affect GME, teaching hospitals, and the teaching environment
• Allowing teaching physicians to fulfill the presence requirement to bill for services furnished in teaching settings by providing direct supervision by interactive telecommunications technology
• Expanded list of communications technology-based services available under the primary care exception
• Claiming time for residents furnishing telehealth services from homes or other clinical sites
• CY 2021 Physician Fee Schedule proposals to extend some of these temporary policies through the end of the calendar year in which the COVID-19 public health emergency (PHE) ends
• eConsults and virtual care strategies pre-COVID and expansion in response to the pandemic

4. Three Decades of Affiliation Strategies for Academic Medical Centers and Teaching Hospitals—What Have We Learned?
Thomas D. Anthony
James Max Reiboldt

The session will consider three decades of affiliation strategies among providers which can aid in their ability to fulfill their mission and values positions. We learn from history plus we apply the future strategies against the past successes and failures. Academic Medical Centers and Teaching Hospitals are presented unprecedented challenges in today’s health care environment. Competing for top provider talent with whom to affiliate, from the C-Suite down is one of their greatest threats to success. This presentation examines and then concludes upon the past three decades of affiliation strategies among providers mainly focusing upon physicians/faculty and related professional support.

• How best to apply the past three decades of provider affiliation transactions toward the opportunities of the future
• Equip Academic Medical Center and Teaching Hospital leadership with real world examples of successful affiliation strategies that will respond to their unique needs in the next decade (or longer)
• Specific case studies of both past successes and failures of affiliation transactions among providers in academic institution settings
• The nuances of academic institutions to progressive strategies for provider affiliation

5. The Times They Are a Changing: A Discussion with Senior Counsel from Three AMCs
Jeffrey D. Kahn (Moderator)
Carl Bergetz
Deborah A. Hodys
Steve Zweck-Bronner

Join senior counsel from three academic medical centers from different regions to hear about their challenges of the past year and how they are planning for the future. Among issues to be discussed:

• Assessing legal and compliance risks in a dynamic environment
• Crisis management and the role of the AMC in-house counsel
• Government agency decisions and interactions
• Impacts of the crises on the different parts of the AMC mission and legal responses

Tuesday, January 26, 2021

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

Carrie Byington
Holly Fernandez Lynch

• An “in the trenches” perspective from a major health system on the vaccine rollout. Assuming that a vaccine has been authorized and vaccination has begun, how have the early days of allocation and vaccination gone?
• Logistic challenges with the administration and tracking of mass vaccination, especially with one or more two-dose vaccines
• Ongoing vaccine clinical trials and the difficulties with enrolling subjects when a vaccine is available
• Key legal and ethical issues for academic medical centers related to clinical trials, vaccination of children, and allocation questions

8. The PREP Act: Understanding Its Role, Scope, and Limitations During a Public Health Emergency
Nathan A. Brown
Richard T. Harper
Hillary Noll Kalay

• Overview, history, and purpose of the PREP Act
• Application–covered countermeasures and distribution requirements
• Immunity–who and what it immunizes and the limitations
• Countermeasures Injury Compensation Program ("CICP")–scope and limitations
• Key Guidance, HHS-OIG advisory opinions, case law, and COVID-19 Declaration
• General and recent examples
  • Treatments and diagnostics (marketing, reporting requirement for injuries)
  • LDTs, PPE – items developed by a specific medical provider for use by that provider, and inability to obtain an EUA for LDTs – what that means for PREP Act
  • Investigational treatments/vaccines in research (prior to EUA) (address informed consent and institutional policies on insurance and sponsor responsibility)
• Future public health emergencies: Potential reforms

9. New, Innovative, Revenue-Generating Ideas for AMCs…No, Really! 
Martin D. Brown
Lawrence W. Vernaglia

The presentation will take the participants through an overview of innovative and non-traditional business development opportunities. These will be real life examples of what some of the top rated, highly recognized AMCs are undertaking to diversify their revenue streams. The speakers will present mini-summaries of some of these strategies with insights from interviews with leaders from various organizations. This session will cover:

• How to generate ideas for their own AMC
• Ways to help the legal department migrate from a “cost center” to a “revenue center”
• Regulatory and compliance considerations associated with such ideas

Jack Beal
Christopher T. Collins

• Incentive-based mission support arrangements with shared risk/reward between the health system and medical school
• Performance-based arrangements between the hospital and employed physician organization(s)
• Balancing investments between the clinical and academic enterprise
• Aligning internal funds flow with realities of external market forces
• Updates on Stark and AKS relevant to these emerging models

Sarah V. Ferranti
Isaac R. Rodriguez-Chavez

The unique challenges posed by COVID-19 have helped push the clinical trial industry towards innovative clinical trial models, including decentralized clinical trials (DCTs). Unlike traditional clinical trials, which are characterized by a series of onsite visits at a single clinical trial site, DCTs may be executed through use of technology, such as telehealth for conducting virtual visits, electronic systems for obtaining informed consent, or digital health technologies for collecting data from participants, as well as other “remote” strategies including shipment of investigational medical products to participants’ homes or use of local health care providers to assist with trial-related functions. This session will provide background on DCTs and address key operational and regulatory challenges in implementing DCTs at academic medical centers and teaching hospitals. More specifically, we will discuss:

• Characteristics of DCTs, including fully decentralized trials and partially (hybrid) decentralized trials
• Advantages of DCTs, including convenience, patient engagement, efficiency, and diversity, as well as potential drawbacks
• The role of the investigator and the concept of a site in DCTs, including obligations to oversee “virtual” and “remote” providers
• State requirements for telehealth and shipment of investigational medical products
• Human subjects protection issues that arise in the context of DCTs, including privacy/security of participants' data, emergency medical access, remote monitoring of data, and adverse event reporting from multiple geographical areas

On-Demand Offerings

• There are three risk considerations when a clinician has a patient who resides in another state: Licensure, malpractice liability, and liability insurance
• Licensure: When is the clinician considered to be “practicing medicine” in the other state such that licensure is required? Going to see the patient in the other state? Conducting a billed or unbilled-for telehealth visit? Writing or refilling a prescription in follow-up?
• Malpractice Liability: Under what circumstances is a clinician at risk of being subject to the jurisdiction of a foreign state for malpractice liability? What factual scenarios carry the most risk?
• Liability Insurance: What is the risk to the clinician and the clinician’s institution of exposure to malpractice liability in a foreign jurisdiction? Does the liability program at the institution cover out-of-state liabilities? How to best manage those risks?

Ivy Baer
Jacqueline E. Levesque

• Why Medicare pays teaching hospitals for direct graduate medical education (DGME) and why those hospitals also receive the indirect medical education (IME) adjustment
• The rules that Medicare follows to determine each hospital’s DGME payment and IME adjustment
• Which DGME and IME rules have changed during the public health emergency
• On-the-ground advice from an Associate Dean of Faculty Affairs who knows the real in and outs of running a GME office
  

III. Avoiding Legal and Regulatory Pitfalls in Clinical Research—A Discussion of Risks and Mitigation Techniques for Academic Medical Centers
Matthew E. Albers
Benjamin D. Bresnick

• The economic and operational impact for academic medical centers engaging in clinical research activities
• Significant compliance concerns emanating from clinical research activities
• The areas where compliance concerns seem to originate and some of the causes of these concerns
• The important differences and similarities between government and industry sponsored research
• Major enforcement actions and implications for ongoing compliance and legal oversight
• Helpful pointers and considerations to review to help proactively identify risks prior to enforcement actions

• Model Rules technology competency requirements
• Apply Model Rules’ technology competency requirements to health law practice
• Risks and professional liability issues associated with technology