ITEM #:  1027551901   |   EVENT CODE:  273137


Wednesday, June 19, 2019 - Thursday, June 20, 2019

8:50 AM - 4:45 PM   |   Check-In:  8:15 AM

Minnesota CLE Conference Center

600 Nicollet Mall # 370

3rd Floor, City Center

Minneapolis, MN 55402

2019 Health Law Institute

Expert Insights on Key Developments and Real-World Scenarios!

The 2019 Health Law Institute brings you experts from private practice, in-house legal, compliance and government – all there to share real-world advice and practice tips for tackling complex legal, technical and business issues. In addition to important plenary sessions, extensive breakout session choices allow you to create a conference experience that best meets your practice needs. This year’s sessions include:

  • 2019 Healthcare Litigation Update – The ACA and More
  • New Healthcare Fraud and Abuse Developments
  • 2019 Privacy and Data Security Update
  • New and Emerging Benefit Models – How to Get to Implementation Beyond the Regulatory Chaos
  • Device and Pharma Update – Key Issues and Initiatives at FDA and Congress
  • Minnesota Legislative, Agency and Enforcement Updates
  • Beyond the Basics – How to Handle Tough Breach Questions
  • Responding to Government Audits
  • Medicare Advantage and Part D Update
  • Hot Topics for Medical Staff Leaders and Counsel Who Advise Them
  • Electronic Health Records – Including Newly Proposed Interoperability Rules
  • And More!

There also will be a unique opportunity to hear from Ellen Nadeau – Deputy Manager, Privacy Framework, National Institute of Standards and Technology (NIST) – who will brief attendees on NIST’s development of a voluntary privacy framework as an enterprise risk management tool. Then, you can elect one or two of the designated breakout sessions to join active discussions facilitated by Ms. Nadeau, to advance the development of the framework.

Day 1 – Wednesday, June 19

8:15 – 8:50 a.m.


8:50 – 9:00 a.m.


9:00 – 9:30 a.m.

2018-2019 ACA Litigation Review: Straining the Acronym Soup
The past year has been busy with Affordable Care Act (ACA) related litigation, with ongoing cases over the validity of the individual mandate, cost-sharing reductions, the risk adjustment program, association health plans, short-term plans, and more. This session will outline the key issues and status of the most important cases, helping practitioners distill down to the most critical potential impacts for clients and the system overall.
– Caitlyn Francois

9:30 – 10:30 a.m.

Healthcare Fraud and Abuse Update 2018-19: Notable Cases, Developments and Trends
This plenary session will highlight significant developments during the past 12 months, including trends in recent False Claims Act litigation and settlements, proposed changes to key fraud and abuse authorities, and enforcement priorities within the Department of Health and Human Services.
– Thomas Beimers

10:30 – 10:45 a.m.


10:45 – 11:45 a.m.

Minnesota Agency Updates
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.
– Attorney General Keith Ellison, Steve Kelley, Jan Malcolm & Stacie Weeks
– David M. Aafedt (moderator)

11:45 a.m. – 12:15 p.m.


12:15 – 1:00 p.m.


Doctor Says…What Lawyers Can Learn in Conversation with Physician and Hospital Leaders
In this session, Paul Harris, Vice President & General Counsel of CentraCare, will facilitate an informative discussion among physicians and hospital leaders, designed to give useful, practical insight to how health lawyers can be more clear, efficient, and effective in their communication with clients and organizational leaders.
– Dr. Joseph M. Blonski, Dr. Cindy Firkins Smith & Dr. Thomas G. Schrup
– Paul R. Harris (moderator)

1:00 – 1:15 p.m.


1:15 – 2:15 p.m.


Provider Privacy Hotspots: Social Media, Proactive Monitoring, and Genetic Information

Expert insights on key privacy and data security issues being encountered – and on the horizon – for provider entities in the healthcare space. Topics will include social media breaches, medical device IoT security, genetic information privacy, and more. The panelists will share practical updates and tips for proactive, programmatic approaches for effective preparation and compliance.
– April Carlson

2019 Healthcare Litigation Update

This session will review recent caselaw developments relevant to health lawyers (including but not limited to litigation related to the Affordable Care Act), along with practical implications for your clients.
– Caitlyn Francois & Archana Nath

Responding to Government Audits: Specific Tips That Will Produce Better Outcomes for Your Client

There’s more than one right way to respond to specific issues that arise in government audits – and there’s more than one way to set up the roles that compliance and legal may play in determining those responses. That said, there are more effective ways than others to plan and execute an entity’s response to a government audit. This discussion will highlight concrete ways to improve how you work with a client – as between legal and compliance professionals – to respond to government audits, leaving you with practical take-aways and lessons learned. We will look at strategies for responding to real-life scenarios including determining whether and how to challenge the scope of the government’s data request; data collection protocols; documentation of the audit process; divvying up responsibilities between audit and legal functions; and more.
– Ann Beimdiek Kinsella & George Lyford

Ethical Considerations in Contract Drafting and Negotiation

1.0 ethics credit applied for
A real-world look at contract drafting and negotiation scenarios that generate legal ethics issues…and how to anticipate and handle them effectively and ethically.
– Susan M. Humiston, John Liethen & Mai Lee Yang

2:15 – 2:30 p.m.


2:30 – 3:30 p.m.


Beyond the Basics: How to Handle Tough Breach Questions

This session assumes a working knowledge of breach-response protocol. By way of real-world types of examples, this session will tackle specific, tough questions that privacy/security lawyers encounter including: does the notification clock start ticking when an incident is suspected but not confirmed; what to do if the incident plan isn’t working; and are there situations when proactively providing notice is a good idea (even if it is not required).
– Mitchell W. Granberg & Anna Shimanek

Healthcare Fraud and Abuse Outlook: Beyond the Update
Expanding upon the morning plenary update session, this panel discussion will bring together diverse private practice and government perspectives to highlight the most important recent developments and trends related to fraud and abuse enforcement activity, leaving you with practical take-aways and lessons learned.
– Joseph T. Dixon & Pamela A. Marentette
– Thomas Beimers (moderator)

Medicare Advantage and Part D Update

An update on recent CMS changes to Medicare Advantage and Part D Plans and how those changes impact payer, provider, and pharma clients.
– Erin E. Weber & David O. Ault

Business Process Outsourcing Concepts for the Health Lawyer

The session will provide an overview of key considerations in structuring and negotiating healthcare business process outsourcing agreements, including delegation of regulated activities, risk allocation, vendor oversight, audit rights, regulatory compliance, and more.
– Frederik W. Struve

3:30 – 3:45 p.m.


3:45 – 4:45 p.m.


Beyond HIPAA: Health Industry Privacy and Security Update

This essential update for the health law attorney covers new privacy and security developments beyond HIPAA enforcement. Topics will include GDPR, the California Consumer Privacy Act, and state law developments.
– Ross C. D’Emanuele

Device & Pharma Update: Navigating the Healthcare Landscape in Washington from Congress to 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. Among other topics, this session will discuss Congressional and FDA initiatives in affordability, access, innovation, cybersecurity, diagnostic testing, safety, and pre/post-market surveillance.
– Ralph F. Hall & Brent G. Eilefson

Smooth Sailing on Choppy Waters: Provider Integration in an Uncertain Environment
There is no one “right way” to integrate and what works for one provider might not be the right fit for another. Physicians, hospitals and other providers bring a range of sometimes competing business needs and financial priorities to transactions and different perspectives on fair market value, all while operating in a complex regulatory and reimbursement environment. As the population ages and payment systems shift towards rewarding bundles of care, providers and their counsel sometimes struggle to understand available options. From management agreements, true joint ventures, coverage arrangements to fullfledged mergers, this session will walk through a range of integration models and discuss the pros and cons of various approaches.
– Jennifer Reedstrom Bishop

4:45 – 5:45 p.m.

Cap the day by sticking around for the annual Institute reception. Join your colleagues and friends in the health law bar for conversation and community!

Day 2 – Thursday, June 20

8:15 – 8:50 a.m.


8:50 – 9:00 a.m.


 9:00 – 9:30 a.m.

2019 Minnesota Legislative Session
An essential update for the Minnesota health lawyer, addressing developments from the 2019 Minnesota legislative session of importance to the health industry and its patient consumers.
– Phil Griffin

9:30 – 10:30 a.m.

2019 HIPAA Privacy and Security Enforcement Update
Steve Mitchell, the Acting Midwest Regional Manager for the HHS Office for Civil Rights, will report on major HIPAA enforcement cases that HHS OCR has concluded and made public over the past 12 months. In addition, he will provide an update on other privacy and security developments out of HHS.
– Steven M. Mitchell

10:30 – 11:00 a.m.

Brief on New NIST Privacy Framework Development
Ellen Nadeau – Deputy Manager, Privacy Framework, National Institute of Standards and Technology (NIST) – will brief Institute attendees on NIST’s development of a voluntary privacy framework as an enterprise risk management tool. Learn what to expect from the new Privacy Framework – targeted for release later in 2019 – and how it could benefit your organization and clients.
– Ellen Nadeau

11:00 – 11:15 a.m.


11:15 a.m. – 12:15 p.m.


NIST-Facilitated Discussion to Get Your Input on the New Privacy Framework – Topic #1

Ellen Nadeau – Deputy Manager, Privacy Framework, National Institute of Standards and Technology (NIST) – will be this session’s discussion group leader. Institute attendees are invited to actively engage in facilitated discussion to advance the development of the new Privacy Framework. NIST will use the breakout session’s input to validate or adjust the discussion draft of the Privacy Framework, to support the next stage of development of the framework. Additional information about the particular breakout session topic for this session will be shared closer to the event.
– Ellen Nadeau

Tracking the Elusive Unicorn: How to find the Win-Win-Win in Value-Based Contracting

Value and outcomes based reimbursement is here to stay, even though providers and payors sometimes struggle to operationalize programs in way that can achieve the goals of the Tripe Aim. This session will provide a comprehensive exploration of important considerations for successful value-based contracting: the drivers of value-based contracts from both governmental and policy perspectives; an overview of key CMS and CMMI reimbursement programs; legal considerations within the four-corners of the deal documents; strategies for addressing Stark Law and other regulatory matters that arise in value-based arrangements; practical tips on negotiations with private plan and public programs; and more.
– Jesse A. Berg & Santo Cruz

Electronic Health Record: Contracting Data Security

The world of medical records is mostly an electronic one, and along with those records systems come complicated contracts and data security worries. Briar and Steve will discuss some of the most important contracting issues, ways that you and your clients can protect from some of the most common problems, tactics to manage risk in the electronic world – and what to keep your eye on with respect to newly proposed interoperability rules from HHS.
– Briar A. Andresen & Steven E. Helland

21st Century Healthcare – Telemedicine: Navigating the Legal Challenges of Licensing, Scope of Practice and Standard of Care

With over 70% of providers now utilizing some form of telemedicine in their practice, and 75% of patients willing to attend a doctor’s appointment by video, there is no question that telemedicine is here to stay. Like any other developing area, however, there are legal risks and traps for the unwary. This presentation will cover the major types of telemedicine and their potential legal pitfalls with respect to licensing, scope of practice and standard of care – and how to best anticipate and handle those evolving legal issues.
– Paul R. Harris & Katherine B. Ilten

12:15 – 1:15 p.m.

LUNCH (on your own)

1:15 – 2:15 p.m.


NIST-Facilitated Discussion to Get Your Input on the New Privacy Framework – Topic #2

This is not a repeat of the facilitated discussion from the previous session, #401. In this session, Institute attendees are invited to actively engage in a NIST-facilitated discussion about a different topic related to the new Privacy Framework. The specific topic for this session will be shared closer to the event. NIST will use the breakout sessions’ input to validate or adjust the discussion draft of the Privacy Framework, to support the next stage of development of the framework.
– Ellen Nadeau

New and Emerging Benefit Models: How to Get to Implementation Beyond the Regulatory Chaos

What benefits must or may healthcare plans provide now and in the future? It sounds like a straightforward question to answer, but the near-daily developments regarding the Affordable Care Act (ACA) over the past two-plus years have left uncertainty on many fronts. This session will detail new and innovative efforts from health insurers, employers, and associations, in response to legal and regulatory changes in the ACA and other laws. How can coverage be offered through an Association Health Plan? In what ways can short-term coverage be structured to comply with the ACA and state laws? Which other ACA-related uncertainties most challenge and inspire the creation, negotiation, and implementation of new benefit models? And how are industry players successfully tackling these uncertainties to craft truly workable and effective models?
– Jason K. Englehart & Paul A. Sand

Hot Topics for Medical Staff Leaders and Counsel Who Advise Them

The medical staff plays a critical and evolving role in a hospital’s efficient delivery of quality care. This session will discuss incorporating recently issued state and federal opioid prescribing guidelines into medical staff quality standards, applying opioid addiction treatment best practices to impaired practitioners, issues and strategies in incorporating advanced practice professionals as part of and alongside the medical staff, and the latest updates to the NPDB Guidebook.
– Mary Foarde & Laura J. Nelson

2:15 – 2:30 p.m.


2:30 – 3:30 p.m.


Drug Price Policy and Other Key Developments Affecting Drug Costs

This session will highlight some of the more impactful current federal and state drug price policy actions (and proposed actions) and explore how these changes could reshape the prescription drug distribution industry: Will drug costs go down if rebates are eliminated entirely? Who would benefit (or not) from government ‘negotiation’ for drug prices or from drug price controls? Will drug price or cost transparency result in lower prices (and for whom)? We will discuss these questions and other possible implications from the rapidly changing drug price policy landscape.
– Tricia A. Beckmann & Jay A. Warmuth

Reps & Warranties in Healthcare Industry Transactions
Healthcare transactions can subject the parties to regulatory risks that are fundamentally different from those the parties have seen before. Well-drafted representations and warranties are a key method of managing these risks. This session explores how such representations and warranties (regarding government programs, privacy and security, medical device regulation, and other areas) can protect your clients.
– Kari Bomash & Jill R. Radloff

The Future Is Now: Emerging Issues with Digital Therapeutics

Evidence-based digital therapeutics offer potential to improve health care quality, outcomes, and value through the use of advanced technology and data-driven interventions. This session will provide an overview of the technology and associated legal/ regulatory issues, including the interfaces with FDA, FTC, privacy and security, fraud and abuse, reimbursement aspects, and more.
– Ryan S. Johnson

3:30 – 3:45 p.m.


3:45 – 4:45 p.m.

A Great I.D.E.A. for Healthcare and Health Law – The Fight for Health Equity!
1.0 elimination of bias credit applied for

James C. Burroughs II is Chief Equity and Inclusion Officer at Children’s Minnesota. In that role, he is responsible for developing, implementing and advocating for a comprehensive health equity, inclusion and diversity strategy. Mr. Burroughs has more than 25 years of experience in the areas of non-profit management, diversity and inclusion and employment law. He has helped both for- and non-profit organizations develop workplace diversity and inclusion training, policies and procedures that promote hiring and retention of employees of color, and partnerships with communities of color and other diverse communities. This session will offer his key values and learnings in approaching this work – applicable to healthcare, the roles lawyers play in the healthcare system, and the legal profession.
– James C. Burroughs

In-Person Live Presentation

Wednesday & Thursday, June 19 & 20, 2019
Minnesota CLE Conference Center
600 Nicollet Mall, Suite 370
Seventh Street & Nicollet Mall
Third Floor City Center
Minneapolis, Minnesota

In-Person Replays

There are no in-person replays.

$545 MSBA members / $545 paralegals / $645 standard rate

Other discounts that may apply:

Scholarships available!
Minnesota CLE maintains a scholarship program for those individuals with a financial need. For more information or to obtain a scholarship application, contact Grant at 651-254-2111 or gdavies@minncle.org.

Minnesota CLE is applying to the Minnesota State Board of CLE for 12.25 standard CLE credits. This total includes 1.0 ethics credit for session #104 and 1.0 elimination of bias credit for the Day 2 concluding plenary. The maximum number of total credits attendees may claim for this course is 12.25 credits.

Minnesota CLE is applying to the IAPP for CPE eligibility for select privacy/security related sessions.

Registrants will receive electronic access to the seminar written materials through the Minnesota CLE website a few days prior to the Institute. At the seminar, attendees will receive hardcopy materials for the plenary sessions and breakout sessions attended. To ensure you have access to the materials in the most timely manner, please set up a free login account at www.minncle.org as soon as possible, if you do not already have one.

Can't attend the Institute? You can purchase the 2019 Health Law Institute Manual in hardcopy for $95 (plus tax and handling) by calling Minnesota CLE at 651-227-8266 or 800-759-8840. Orders will be filled after the Institute. The electronic version is available for $95 (plus tax) and may be purchased at www.minncle.org after July 8, 2019.