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ONLINE
Tuesday, June 15, 2021 - Wednesday, June 16, 2021
8:50 AM - 5:00 PM
LIVE ONLINE ONLY – NO IN-PERSON ATTENDANCE
In-Person Passholders – You may use your Pass to register for the live webcast at no charge.
Get Actionable Guidance on New Health Law Developments – Plus, New Know-How to Tackle Challenging Client Matters
The 2021 Health Law Institute will keep you in step with important new developments, including the impacts of COVID-19 and the new Administration, new Congress, and new Supreme Court in Washington, D.C.
Institute highlights include:
By attending the 2021 Health Law Institute, you will gain firsthand access to the thought leadership and expertise of professionals representing the area’s healthcare providers, payers, government, and pharmaceutical/medical device industries. In a time of change and uncertainty, the Institute helps put things into focus!
8:05 – 8:50 a.m.
JOIN ONLINE
8:50 – 9:00 a.m.
WELCOME & INTRODUCTION
9:00 – 9:15 a.m.
The Health Law Themes of 2021
With the pandemic, changes in D.C., new cases and new rules, and other important developments, it can feel like drinking from a fire hose trying to keep up with everything new that’s impacting your health sector clients. In this kickoff session, Paul Sand distills significant changes to provide a digestible big-picture look at what’s new.
– Paul A. Sand
9:15 – 10:00 a.m.
What’s Next? Future Implications of Today’s New Developments – And What Other Changes Tomorrow May Bring
Experts with diverse practice perspectives discuss their health law predictions. What should providers, payers, drug and device makers, supporting vendors, and healthcare consumers keep an eye out for?
– Kenneth Y. Choe, Caitlyn E. Francois, Venice Haynes, PhD & Jamie Buskirk McCarty
– Paul A. Sand (moderator)
10:00 – 10:15 a.m.
QuickTake Interview – Promoting Startups, Pursuing Entrepreneurialism and Accelerating Innovation with Launch Minnesota
To help Minnesota’s startup companies grow and develop, the Minnesota Department of Employment and Economic Development created the Launch Minnesota initiative to accelerate startups and grow Minnesota’s innovation ecosystem. Adam Young from UnitedHealth Group interviews the program’s Executive Director Neela Mollgaard to discuss the program, Minnesota’s startup community, and several of the startups in the healthcare space that have received grants.
– Neela Mollgaard
– Adam R. Young (interviewer)
10:15 – 10:30 a.m.
BREAK
10:30 – 11:15 a.m.
Healthcare Fraud and Abuse Update 2020-21: Notable Cases, Developments and Trends
This plenary session will highlight significant developments during the past 12 months, including trends in recent False Claims Act enforcement and settlements, amendments to key fraud and abuse authorities, and potentially lasting shifts in the regulatory landscape due to the global pandemic.
– Thomas Beimers
11:15 a.m. – 12:00 p.m.
Prescription Drug Policy and Innovation – What Significant New Developments Mean for Drug Cost and Access
Reining in prescription drug costs is at or near the top of the health policy priority list for many state and federal policymakers and politicians on both sides of the aisle. Many state laws have been enacted over the last few years attempting to address increasing drug costs and/or certain aspects of the drug distribution system that impact costs, ranging from manufacturer price transparency measures and authorizations to import certain drugs from Canada to increasing state-level oversight of pharmacy benefit managers (PBMs). We also have seen numerous federal regulatory actions aimed at reducing government program and/or beneficiary drug costs. Further, increasing drug costs have spurred private sector innovations in the prescription drug distribution system, such as value-based rebate arrangements, high-cost drug management programs, and new market entrants. This presentation provides an overview of recent state and federal policy actions and private sector developments and assesses the impact of these developments on both drug costs and access.
– Jay A. Warmuth
12:00 – 12:15 p.m.
QuickTake Interview – Looking at the Numbers with the Founders of the U’s COVID-19 Hospitalization Tracking Project
Maria Christu, Chief Legal Officer at Children’s Minnesota, “sits down” with the founders of the University of Minnesota COVID-19 Hospitalization Tracking Project – a 2021 finalist for the NIHCM Digital Media Award and winner of AACSB’s annual Innovations That Inspire recognition. Those project founders – Archelle Georgiou, MD and professors Pinar Karaca-Mandic and Soumya Sen – will talk about the inception of the project, challenges and a-ha moments, and some of the vital information they’ve discovered with consistent tracking and analysis of daily COVID-19 hospitalization data.
– Archelle Georgiou, MD, Pinar Karaca-Mandic, PhD & Soumya Sen, PhD
– Maria C. Christu (interviewer)
12:15 – 1:00 p.m.
LUNCH BREAK
1:00 – 1:45 p.m.
BREAKOUT SESSION A
101
The No Surprises Act and Other Key Healthcare Provisions in CAA 2021 – What’s Changed and How to Comply
The 2021 Consolidated Appropriations Act ushers in some big changes for the healthcare industry – among them restrictions on surprise out-of-network billing and requirements for helping patients get healthcare cost information. In this session, the chief legal counsel from payer UCare and from provider CentraCare outline the key healthcare provisions in CAA 2021. They also discuss how to comply with the new requirements – including the challenging question of how providers and payers can work together to meet their obligations where such cooperation is a necessity.
– Santo Cruz & Daniel D. Santos
102
In-Depth Look: Key Stark Law and Anti-Kickback Statute Developments
Major changes were made to the Stark Law and Anti-Kickback Statute in 2021. New regulations have created exceptions and safe harbors designed to allow providers to succeed in value-based reimbursement models, revised critical concepts such as when compensation takes into account the volume or value of referrals and revamped compensation rules for physician group practices. This session will focus on critical changes to these important laws, including how to apply the new value-based rules and other practical implications for providers and health care attorneys.
– Jesse A. Berg
103
Telemedicine 1 – Navigating the Legal Challenges of Licensing, Scope of Practice, and Standard of Care
Market forces, changes in law, and the practical realities of the pandemic have resulted in a massive expansion in telemedicine. However, a number of questions remain, such as “who can practice via telemedicine?”, “what kinds of services can they offer?”, and “what kinds of services are covered?” In this first installment of a three-part series, Laura Nelson and Jason Engelhart will explore these questions and their ever-shifting answers.
– Jason K. Engelhart & Laura J. Nelson
1:45 – 2:00 p.m.
BREAK
2:00 – 2:45 p.m.
BREAKOUT SESSION B
201
Medicaid Developments – COVID Impacts, Shifts Under the New Administration, Mental Health Parity Trends and More
Over the past year, there have been significant developments in the Medicaid program in a variety of areas. To set the stage, we will begin with a brief discussion of the current state of Medicaid managed care. We will then provide an overview of recent developments including COVID relief packages and their impacts to Medicaid, shifts in Medicaid work requirements under the new Administration, impacts and trends in mental health parity and opportunities and risks associated with enhanced interoperability.
– Clifford E. Barnes & Candy Bajwa Olson
202
Handling False Claims Act Investigations
Hear a panel of experts discuss investigative issues arising out of the False Claims Act and other health care fraud. Learn about enforcement initiatives that give rise to investigations, how to identify compliance risks at the forefront, how you should approach investigations, and best practices to achieve compliance and avoid investigations or mitigate consequences. Our experts will also provide ideas on what health care and life sciences companies can do if they become aware either before or during a government investigation that there has been fraud or inappropriate billing activity.
– Chad A. Blumenfield, Habib F. Ilahi & Sheva Sanders
203
Telemedicine 2 – Protecting Patient Privacy and Data Security in Telehealth
Virtual visits, electronic messages between providers and patients, patient monitors that transmit data back to the provider, and other telehealth opportunities bring with them obligations for protecting patient privacy and data security. Join privacy and cybersecurity expert Michael Stoker for practical guidance on what those requirements are and what’s considered best practices in implementation. You’ll also hear about the current cyberthreat environment as related to telehealth data security.
– Michael A. Stoker
2:45 – 3:00 p.m.
BREAK
3:00 – 3:45 p.m.
BREAKOUT SESSION C
301
Information Blocking: Fact Versus Fiction
We will cover the basics of information blocking regulations for health care providers, as well as provide an update on agency guidance and FAQ issuances since January 2021. We will also dig into areas of debate and outstanding questions, such as the use of patient portals, whether a health care provider can delay lab results, and how quickly information must be provided after receiving a request. Finally, we will discuss the status of the enforcement regime for information blocking and what to expect in future rulemaking on enforcement.
– Katherine B. Ilten
302
Overview of the CARES Act Provider Relief Fund – Reporting Requirements, Investigations and Enforcements
This session will discuss the details of the CARES Act Provider Relief Fund pertinent to health law attorneys and health care organizations. Understand the shifting landscape of the various distribution phases of the Provider Relief Fund including provider eligibility and permitted uses of the funds. Learn about the reporting requirements to ensure compliance with the law, and learn about current and possible investigations and enforcement issues arising out of non-compliance or violations of the law.
– Christianna L. Finnern
303
Telemedicine 3 – Pitfalls: Fraud and Abuse Risks
In this session attendees will understand the myriad of legal risks and pitfalls associated with providing telemedicine services and how to avoid them. Attendees will learn about classic fraud and abuse issues such as compliance with the Stark Law and Anti-Kickback Statute applied to telemedicine, recent enforcement trends particularly related to the increased use of telemedicine during COVID, billing compliance risks, and risks arising out of the use of telemedicine platforms such as the corporate practice of medicine and fee splitting.
– Peter B. Hofrenning & Steve J. Lokensgard
3:45 – 4:00 p.m.
BREAK
4:00 – 5:00 p.m.
Elimination of Bias – Racial and Ethnic Inequalities in Healthcare – What Every Health Lawyer and Healthcare Organization Needs to Understand
1.0 elimination of bias credit applied for
Experts working in the healthcare space discuss the current inequalities and structural barriers existing in healthcare, how these problems continue to persist, and what can be done to tackle and resolve these issues. Furthermore, this panel discussion will provide the necessary understanding for health attorneys to make sure their own bias isn’t trickling down through their advice to clients in a way that creates barriers or adds to inequality. Learn what steps you as a health lawyer can take to address these issues and help resolve inequalities.
– Dawn Hunter, Montrece M. Ransom, Sarah E. Swank & Ruqaiijah Yearby
5:00 – 5:45 p.m.
RECEPTION
Catch up with friends and make new connections, too, in face-to-face casual conversation in the Institute virtual gathering space. Enjoy the collegiality, leave energized, and get a chance to win great prizes!
8:05 – 8:50 a.m.
JOIN ONLINE
8:50 – 9:00 a.m.
WELCOME & INTRODUCTION
9:00 – 10:00 a.m.
2021 Minnesota Agency and Enforcement Panel
Hear priorities and updates from Minnesota’s health law regulatory agencies, followed by panel Q&A covering additional insights and analysis of the current healthcare legal landscape.
– Commissioner Grace Arnold, Commissioner Jodi Harpstead & Commissioner Jan Malcolm
– David M. Aafedt (moderator)
10:00 – 10:15 a.m.
QuickTake Interview – Epidemiologist Michael Osterholm on Getting to the Pandemic Finish Line
Dr. Michael Osterholm’s is a name the health community has known for decades, and one that is very much in the forefront of national news these days as an expert on the COVID-19 pandemic. Former Medica general counsel Jim Jacobson will talk with Dr. Osterholm about his work on President Biden’s 13-member Transition COVID-19 Advisory Board, how public health discussions of all kinds will change moving forward based on what we’ve experienced in the pandemic, and what the COVID-19 “finish line” will look like.
– Michael T. Osterholm, PhD
– James P. Jacobson (interviewer)
10:15 – 10:30 a.m.
BREAK
10:30 – 11:15 a.m.
2021 HIPAA Privacy and Security Regulatory and Enforcement Update
The presentation will contain regulatory updates, COVID-19 policy announcements and reminders, breach notification statistics, a listing of the last year’s enforcement actions, and a discussion of some best practices in response to those enforcement actions.
– Steven M. Mitchell
11:15 a.m. – 12:00 p.m.
2021 Healthcare Litigation Update – Trends, High-Impact Suits and Practical Implications
This session will review recent caselaw developments relevant to health lawyers, pointing out trends in the litigation (rulings, types of cases, etc.) and the practical implications for your clients. In addition, Paul Harris and Jamie Kurtz will discuss high-impact lawsuits including California v. Texas, which questions the constitutionality of the ACA as a whole, and Popovich v. Allina Health, in which the Minnesota Supreme Court held that hospitals may be vicariously liable for the actions of their independent-contractor providers.
– Paul R. Harris & Jamie R. Kurtz
12:00 – 12:15 p.m.
QuickTake Interview – Discussing the Impact of COVID-19 on IT with Mayo Clinic’s Cris Ross
COVID-19 impacted health organizations in more ways than one. Rick Martinez from Jones Day sits down with Mayo Clinic Chief Information Officer Cris Ross to discuss how the pandemic has impacted Mayo Clinic’s approach to technology, lessons learned during the health crisis, and what the industry should expect in the future.
– Christopher J. Ross
– Richard M. Martinez (interviewer)
12:15 – 1:00 p.m.
LUNCH BREAK
1:00 – 1:45 p.m.
BREAKOUT SESSION D
401
Medicare Advantage Update – COVID-19 Flexibilities, Integrated Appeals, Supplemental Benefit Requirements, and More
This session will provide an update on Medicare Advantage, the private plan alternative to traditional Medicare. Updates will include an overview on COVID-19 flexibilities, integrated appeals, drug management programs, and supplemental benefit requirements. Whether you work closely with Medicare Advantage plans or are interested in learning more, this session will provide you with information on operational developments for 2021 and 2022.
– Jennifer C. Middleton & Mai Lee Yang
402
Beyond HIPAA – Health Industry Privacy and Security Update 2021
This essential update for the health law attorney will cover new privacy and security developments beyond HIPAA. The program will cover updates on the California Consumer Privacy Act, the new Virginia Consumer Data Protection Act, FTC enforcement actions, amendments to the Part 2 rules on substance use disorder records, and more.
– Ross C. D’Emanuele
403
Workplace Violence Prevention in the Age of the “Active Shooter”
The recent tragic mass shootings in the U.S. have left employers grappling with questions as to what measures they should take – or are legally obligated to take – to keep employees safe from harm in the workplace. Under the federal Occupational Health and Safety Act (OSHA), all employers have a general duty to provide a safe workplace for employees. Adam Fiss will discuss steps that employers can take, including:
– Adam Fiss
1:45 – 2:00 p.m.
BREAK
2:00 – 2:45 p.m.
BREAKOUT SESSION E
501
2020-21 Minnesota Legislative Update
The pandemic forced lawmakers to invent entirely new ways of doing business while the executive branch moved to meet threats to Minnesotans’ health and the economy through Executive Orders. This included a record 7 Special Sessions in 2020. Two veteran healthcare lobbyists review the political landscape of Minnesota, the end of 2020, and legislation considered/passed during the 2021 Minnesota Legislative Session.
– Phil Griffin & Maureen Shaver
502
How to Respond to a Ransomware Incident – Including Whether to Pay the Ransom
When a client falls prey to a ransomware attack, what are the immediate steps to take? This session provides a practical guide to your response. How to:
– Emily M. Holpert & Tedrick A. Housh III
503
Hottest Issues in Employment Law for Healthcare Institutions – COVID Safety Protocols, Frontline Worker Mental Health, and More
– Sara G. McGrane & Penelope J. Phillips
2:45 – 3:00 p.m.
BREAK
3:00 – 3:45 p.m.
BREAKOUT SESSION F
601
Device and Pharma Update 2021 – A Look at What’s Happening on the Hill and at the FDA
Please join us for a session that will review key issues and initiatives relating to FDA’s regulation of therapeutic products, as well as recent and looming Congressional activity in the FDA space.
– Ralph Hall
602
Privacy and Data Security Healthcare Contracts
This session will provide an overview of the privacy and data security issues that are important in a healthcare transactional setting when working with vendors. Learn how to assess data, including regulated data which requires specialized protection terms, and how to ensure you keep information secure with vendors who will hold, host, or manage your confidential data. In addition, learn how to safeguard data when working with affiliates or other business units when working in collaborative ventures.
– Katheryn A. Andresen
603
The Hybrid Workplace Revolution for Health Sector Employers – Navigating Complex Decisions and Implementation
Practical guidance on key questions about implementing hybrid workplaces in the health sector: How does an employer decide who can/must work from home and who can/must be onsite (on a full-time or part-time basis) – and are there possible employment law risks attendant to those decisions? If having at least some onsite work is determined to be desirable, how does an employer successfully map out the necessary logistics (e.g. schedules, workspaces) to meet those objectives? How does an employer make sure that mentoring, promotion, and other types of job opportunities that have traditionally involved in-person interactions continue successfully in a new hybrid environment? How does an employer effectively train managers to make and implement these decisions in a way that is compliant and effective? How does an employer address employees who want to have their primary work location be from home? What if that home is another state or country? And much more.
– Daniel G. Prokott & Nicole A. Truso
3:45 – 4:00 p.m.
BREAK
4:00 – 4:45 p.m.
Value-Based Care in 2021 – 5 Emerging Trends
Health care companies pivoting toward pay for better quality and outcomes, and to control costs, are looking at strategic, value-based arrangements as a way to get there. We cap off the Institute with an experienced legal advisor’s distillation of 5 emerging trends in this space – what we’ve seen over the past year and what we can expect to see in the rest of 2021 and beyond.
– Jeanna Palmer Gunville
Attendees of the 2021 Health Law Institute may view the following 3 webcasts for FREE after the Institute! Instructions on how to register for free will be provided to attendees during the Institute.
Dates and times TBA.
The Growing Role of Artificial Intelligence in Healthcare
– Gary Marchant, PhD
1.0 standard CLE credit applied for
“But I Heard That’s Illegal” – How to Deal with People Who Come in with a Compliance Concern
– David M. Glaser
1.0 standard CLE credit applied for
Legal Ethics Do’s and Don’ts in Internal Compliance Investigations
– Matthew D. Forsgren & David J. Wallace-Jackson
1.0 ethics credit applied for
LIVE WEBCAST
Tuesday & Wednesday, June 15-16, 2021
Attend online
REPLAYS
There are no replays.
$495 MSBA members / $495 paralegals / $595 standard rate
Other discounts that may apply:
Scholarships available!
Need-based scholarships are available for in-person and online seminars. For further information or to obtain a scholarship application, contact us at 800-759-8840 or customerservice@minncle.org.
CREDITS – INSTITUTE
Minnesota CLE is applying to the Minnesota State Board of CLE for 12.25 CLE credits, including 1.0 elimination of bias credit for the afternoon plenary on Day 1. The maximum number of total credits attendees may claim for this program is 12.25 credits.
CREDITS – FREE POST-INSTITUTE WEBCASTS
Minnesota CLE is applying to the Minnesota State Board of CLE for the credits as noted on the Schedule & Faculty tab.
