The event of the year for every health law professional!
25 years and still going strong!
The Health Law Institute continues to provide practical teaching with realistic solutions to everyday and unexpected problems in health law. Join us for this annual event where more than 400 health law professionals gather for a rich educational experience.
New this year! Basics Bootcamp
We heard you: the Basics Track is now a full-day refresher to kick off the Institute!
We’ve made more time for the basics. With longer, more in-depth sessions and more topics, get the health law basics you need at the kickoff event on March 11. Be better prepared for the deep-dive at the Institute and get 6 CLE credits for only $99.
Register for the Basics Bootcamp »
The Institute kicks off with the always popular “Year in Review”
Take this opportunity to stay on top of all of the significant case law developments and regulatory changes in health law in our opening session. In this energetic hour you will be given a journey through all of the new and important case law and regulatory developments by Charles Artz, Barbara Blackmond and Bob Ramsey. It’s the perfect way to explore what is happening across a broad spectrum of health law issues. You’ll also get a glimpse at what is on the horizon in health law.
The much anticipated False Claims Act update
Courts are continuing to release False Claims Act decisions at a brisk pace. Our panel includes Gregory David, Chief of the Civil Division, US Attorney’s Office, Eastern District of PA; Pamela Coyle Brecht and Matthew Hogan. You’ll hear each panelist’s point of view on these cases. You won’t want to miss this lively discussion!
Discover the regulatory and operational issues with value-based reimbursement programs
Our stellar panel, including Christopher Raphaely, Brad Rostolsky and Katherine Schneider, will discuss value-based reimbursement programs and the associated regulatory issues in the market today. They will delve into the real world operational issues and offer practical tips to lawyers and business executives. Andrea Kahn-Kothmann will moderate this informative session.
How are telemedicine providers and tech giants like Amazon, Apple and Google seeking to transform health care?
These digital health disruptors are potential partners for hospitals and health systems. Hear from our knowledgeable panel, including John Harris, Rene Quashie, Kaitlin Rosenthal and Dale Van Demark, about the key legal considerations when partnering with telemedicine and other digital health disruptors. Examine the policy and regulatory implications. Join us for an interesting discussion!
Attorney General Josh Shapiro reveals initiatives on emerging healthcare issues
Attorney General Josh Shapiro will give you a firsthand look at the front lines of the opioid epidemic in Pennsylvania. He will also fill you in on defense against adverse federal action. You will have the opportunity to hear how his office is addressing the most significant and emerging issues in healthcare. Bring your questions – you won’t want to miss this opportunity to hear from Pennsylvania’s Attorney General!
David Nash, MD, MBA explores the current mess in healthcare
David Nash, Dean of Jefferson College of Population Health, explores how our current health care system delivers such low value for the monies we spend. Examine the key concepts of population health and population health management. Take away predictions as to how care will be disrupted via patient engagement and through implementation of the tenets of population health into the delivery system. Join us for this dynamic and engaging session!
Jim Sheehan is back with a fascinating discussion about independent investigations
What lessons can be learned from Wells Fargo, Equifax, Broward Health and other “independent” investigations? Jim Sheehan will examine the ethical duties of attorneys to provide an adequate independent investigation in this thought-provoking ethics hour. Always an Institute favorite!
FBI Supervisory Special Agent Edward You raises your consciousness about challenges to data security in healthcare
With so much health data available, the potential for great discoveries in medicine are also available as well as the potential for exploitation. Edward You will discuss the future of bioeconomy, addressing the promises and unique challenges in security involving health, cybersecurity and the economy. This promises to be an eye-opening session!
Mark Gallant shares trends in out of network provider reimbursement
The last two years have been marked by significant case law developments surrounding provider waivers and discounts of patient co-payments, co-insurance and deductibles. Explore with nationally recognized health lawyer, Mark Gallant, the recent case law and statutory developments. Here is your chance to have an interactive dialogue about defenses to and risk mitigation strategies against plan claims arising out of fee waivers and discounts and the hazards of billing full charges. What an opportunity!
Special Thanks to our Institute Sponsors: Silver Level
Pepper Hamilton LLP
Post & Schell, P.C.
Thomas Jefferson University
Ankura Consulting Group, Inc.
Dilworth Paxson LLP
Fox Rothschild LLP
Greenberg Traurig LLP
Horty Springer and Mattern
Pietragallo Gordon Alfano Bosick & Raspanti LLP
Reed Smith LLP
Stevens & Lee
Tuesday, March 12, 2019
8:30 – 8:35
8:35 – 10:05 am
The Health Law Year in Review
Mr. Artz, Ms. Blackmond, Mr. Ramsey
Don’t miss your chance to catch up on all of the important healthcare developments over the past year. Our dynamic panel will bring you the hottest developments related to physicians, hospitals and reimbursement developments. They will also offer their insights into the trends in health law and what lies ahead in these areas.
10:05 – 10:30 am
10:30 am – 12:00 pm
1. False Claims Act Update
Ms. Brecht, Mr. David, Mr. Hogan
The number of False Claims Act cases filed and settled continues to rise. Join our distinguished panel as they examine the most notable False Claims Act cases from the past year. The panel will also discuss major issues that have arisen - or that loom on the horizon - involving the FCA. Always a lively discussion!
2. Value-Based Reimbursement: Today’s Business, Regulatory and Operational Landscape
Mr. Raphaely, Mr. Rostolsky, Ms. Schneider, Ms. Kahn-Kothmann (moderator)
Join us for a discussion of the value-based reimbursement programs and the associated regulatory issues in the market today. Our panel will delve into the real world operational issues associated with these programs and offer practical tips to lawyers and business executives.
3. Amazon, Telemedicine and Digital Health Disruption
Mr. Harris, Mr. Quashie, Ms. Rosenthal, Mr. Van Demark
In this interactive panel discussion, we will address how telemedicine providers and tech giants like Amazon, Apple, and Google are seeking to transform health care. These disruptors are also potential partners for hospitals and health systems. We will address: • Key legal considerations when partnering with telemedicine and other digital health disruptors • The policy and regulatory outlook • How these disruptors may transform healthcare.
12:00 – 1:15 pm
Lunch for all attendees
1:15 – 2:15 pm
4. Physicians End-Running the Payors: Direct Contracting, Concierge Medicine and Opting Out
As physicians struggle with administrative burden and the demand to produce value which likely means less revenue, they also are challenged by increasing administrative demands from payors. Direct contracting cuts the payors out of the transaction with employers dealing directly with physicians. In addition, some adopt concierge medicine tactics of varying types, and finally some opt out of Medicare or go non-participating completely, putting the burden on patients to cope with their payors. There are pitfalls everywhere in these strategies, which this session will address, including direct to employer and direct to consumer contracts.
5. High Noon – Is the Legalization of Medical Marijuana in Pennsylvania Heading for a Showdown with Federal Law?
Attend to understand the details of the Pennsylvania Medical Marijuana Act, including the protections it extends to certified users of medical marijuana. A number of issues that arise because of the conflict between federal and state law will be discussed and analyzed: • The risks that hospitals face by permitting their inpatients to use medicinal marijuana • How health care employers should handle positive drug tests • How to deal with employees or members of the medical staff who show up to work under the influence of marijuana even though they are certified users.
6. Ethical Considerations in Organizing the Compliance Function (ETHICS)
Ms. Lawrence, Mr. Wachlin
As health care organizations emphasize the importance of the compliance function, they are faced with a choice of where to align the function within their organizations. The choice usually boils down to whether: (1) the compliance department should be a stand-alone department with the designated Compliance Officer reporting directly to the President, CEO and Board of Directors; or (2) the compliance function should be aligned as an office in the Legal department with the Compliance Officer reporting to the General Counsel with dotted line reporting to the President, CEO and Board of Directors. Where the compliance function is housed and the reporting structure of the designated Compliance Officer raises a number of ethical issues. Join us to delve into these ethical issues.
7. Romancing the Deal: “Negotiating” a Letter of Intent and Term Sheet
Mr. De Simone, Mr. Washlick
The importance of a Letter of Intent and Term Sheet to help navigate the parties through the course of a business transaction should not be overlooked. Yet, often times, parties skip this important step as a waste of time and money, only to find themselves arguing rather than negotiating. Come to understand the value of a Letter of Intent and a detailed term sheet to keep a transaction on track.
8. Community HealthChoices (CHC): Using Managed Care to Deliver Medicaid-Funded Long-Term Services and Supports (LTSS) in Pennsylvania
Mr. Miller-Wilson, Ms. Torregrossa
The state is implementing its ambitious initiative to have more than 420,000 Pennsylvanians who are dually eligible for Medicare and Medicaid and individuals with physical disabilities receive services from three Medicaid managed care plans. Examine how the program has rolled out in Southwest and Southeast PA, plans for the roll out in the rest of PA starting in 2020 and whether it has helped dually eligibles to receive better coordinated care and better serve those needing LTSS receive those services in the community.
9. Choosing the Best Financing Option for Your Healthcare Facilities
Mr. Brodsky, Mr. Connell, Mr. Cunningham
We will discuss different types of financing for health care facilities, with particular emphasis on tax-exempt financing for capital facilities. Topic include: • Basic mechanics of tax-exempt financings • Types of facilities that are eligible for tax-exempt financings • Overview of legal considerations • Public offerings vs. private placements • Disclosure considerations • Post-issuance considerations.
2:15 – 2:25 pm
2:25 – 3:25 pm
10. Research Compliance: 2018/2019 Year in Review
Come to hear about research related topics in the OIG 2019 Work Plan. We will address any new laws, regulations or guidance provided by research oversight agencies including OHRP, FDA, ORI, and OMB. We will also outline recent enforcement cases related to off-label uses, research misconduct, human research protection violations and much more.
11. Working with Hospital Leadership: Who Is the Client?
Ms. Nagele, Ms. Sher
A hospital is a complex organization with multiple leadership constituencies – board, administration and medical staff. What is particularly unique is that the hospital medical staff is an organizationally distinct entity within the hospital structure, acting as an agent of the hospital in carrying out professional oversight activities. For legal counsel working with hospital leadership, this can give rise to ethical dilemmas and potential conflicts of interest. We will address: • Navigating legal representation with multiple leadership constituencies • Managing the conflicting agendas that can arise in the academic medical centers, community hospitals and multi-entity health systems • Identifying potential conflicts of interest and when to engage separate counsel • Special challenges that arise in a jurisdiction (e.g., New Jersey, California) that recognizes the medical staff as an independent entity capable of suing the hospital.
12. Increased Scrutiny of “No-Poach” Agreements and the Impact on Health Care Practices
Ms. Datte, Ms. Levine, Mr. Young
In recent years, private plaintiffs, the federal antitrust agencies, state attorneys general and Congress have all turned their focus to “no-poach” agreements, which prohibit companies from hiring or soliciting each other’s workers. Private class action plaintiffs have increasingly targeted no-poach and wage-setting agreements with success in fields including health care. We will examine the current governmental and private plaintiff scrutiny of no-poach agreements, particularly as to how they may affect the health care industry in terms of “non-solicitation” and “no-hire” agreements between health care entities.
13. Policy Implications of Big Data in Health Care
Big Data is coming to health care. The widespread adoption of electronic health records (EHRs) in the health care industry means that huge quantities of data can now be generated and stored in data warehouses for use. The benefits of data analytic tools are potentially groundbreaking for the health care industry – high-risk patients can be identified, reducing emergency department costs; hospitals can analyze admission rates over short periods to improve staffing; risk of security breaches and fraud can be prevented; patient outcomes can be improved through wearable devices and other analytical tools that monitor and track patient data and progress. The risks: data mining will put physicians under pressure to reduce substandard performance, destabilizing their relationship with hospitals. Data analytics will uncover higher levels of adverse events, while destabilizing the doctor-hospital relationship.
14. Obtaining and Maintaining Medicare Billing Privileges
Attend to learn the legal considerations relating to the obtaining and maintaining of Medicare billing privileges, including common changes that must be reported, deadlines for reporting changes to enrollment information, the legal impact of failing to maintain enrollment. Explore Part-B enrollment requirements (including physician practices, individual practitioners, and independent diagnostic testing facilities), and examine requirements for DMEPOS suppliers.
15. HIPAA Privacy and Security Enforcement
Mr. Artz, Ms. Holland, Mr. Mayernick
Join us for a discussion of the HIPAA Privacy and Security cases from the Office for Civil Rights over the past few years, including the newly published ALJ decision in OCR v. University of Texas MD Anderson Cancer Center, which resulted in a $4,348,000 fine. That case imposed significant sanctions on the employer even though the misconduct at issue arose from criminal theft by a third party and employee noncompliance with the employer’s policies and procedures. There are other class actions throughout the United States with varying results regarding negligence and other theories asserted against health care providers. All of the decisions yield important compliance points that will be discussed.
3:25 – 3:35 pm
3:35 – 4:35 pm
Pennsylvania’s Attorney General’s Actions on Emerging Healthcare Issues
Attorney General Shapiro
Pennsylvania Attorney General Josh Shapiro will fill you in on the most significant and emerging issues in healthcare and his office’s actions to address them. You’ll hear about responses to the opioid crisis, defense against adverse federal action, and so much more. Bring your questions for the question and answer period to follow!
4:35 – 5:30 pm
The “Safe Harbor” Reception
You are invited to a relaxing and enjoyable reception immediately following the keynote address by our special guest speaker, Attorney General Josh Shapiro. Enjoy great food and drink with the music of our jazz trio in the background. It’s the perfect way to unwind and visit with your colleagues at the end of the day. Join us!
Wednesday, March 13, 2019
8:30 – 9:30 am
17. When Misconduct Allegations Require an Independent Investigation and Doing It Right (ETHICS)
Senior employee misconduct, “behaviors or business practices that are illegal, or unethical,” are risks to your whole organization. Topics include: • Project planning for special board committee or audit committee in overseeing investigation • Lessons from Wells Fargo, Equifax, Rochester, DVA, Broward Health, Uber, and other “independent” investigations • Satisfying the standards for DOJ “presumption of declination” to prosecute with full disclosure and remediation • In Weinstein’s Wake - addressing fairness to accused and accuser, risks to institutional reputation, responsiveness to stakeholders and public.
9:30 – 9:45 am
9:45 – 10:45 am
18. PA Department of Human Services Update
Hear an update on healthcare-related activities of the Department of Human Services in the past year.
19. Damned if You Do, Damned if You Don’t: Hazards for Out of Network Providers From Fee Waivers to Surprise Billings
Explore the changes in the healthcare reimbursement landscape arising out of the proliferation of narrow network and tiered insurance plans, and the corresponding increases in the numbers of providers choosing to “go out of network.” Non-contracted providers frequently offer fee discounts and other waivers of patient financial responsibility as a means of gaining or retaining (after a contract termination) market share. In the first portion of our discussion we will explore the successes and failures of various legal theories that plans are increasingly advancing to deter referrals to out-of-network providers. In the second portion we will examine recent federal and state efforts to limit patient exposure to “surprise billings” and other forms of balance billing (including ACA reforms for out-of-network coverage of emergency medical services).
20. Class Action Check-Up: Alleviating TCPA Risk for Healthcare Providers
2018 was a huge year for the Telephone Consumer Protection Act (TCPA) - a draconian law prohibiting unsolicited text message, fax and telephone communications. In the healthcare context, the law regulates the use of automatic telephone dialing systems to contact patients for debt collection purposes, as well as text messages to send health care-related reminders and confirmations (like flu shot and appointment reminders, lab results, and prescription notifications). The TCPA has become a booming business for plaintiff’s lawyers seeking to take advantage of uncapped statutory damages. And all it takes is one unsolicited communication for a nationwide class action. Recently, we successfully defended such a case against a health system, and can provide helpful insight to minimize the risk of, and defend against, a TCPA class action.
21. Hot Medical Staff Topics for Medical Staff Leaders and Counsel Who Advise Them
Take this opportunity to be updated on significant national trends including: • Medical staff unification within health systems: CMS advocates it; data shows it enhances quality; but the Pennsylvania DOH is not comfortable. How can counsel help Pennsylvania clients? • Trends in Peer Review: the impact of Reginelli on peer review in group practices affiliated with hospitals • Expanding role of advanced practice clinicians • Dealing with sexual harassment allegations in medical staffs in the #MeToo era • Strategies for alleviating physician burnout • 2018 NPDB Guidebook revisions.
22. Risky Business – Compromised Emails
Mr. Bielby, Mr. Packel, Ms. Winchester
In 2017 and 2018, healthcare entities saw a massive increase in email inbox compromise incidents, particularly for those organizations using Microsoft Office 365. Email compromises are on the rise because they are relatively easy to carry out, profitable, and threat actors are able to use the email accounts for a variety of purposes. Attackers can leverage the account to request fraudulent wire transfers, redirect an employee’s payroll, steal sensitive information within the inbox, and send targeted spam emails to other users from a trusted inbox. Attend to hear an incident response expert dive into how these attacks occur, how best to respond, the costs associated with responding, regulatory implications and cost-effective steps your organization can take to prevent these attacks.
10:45 – 11:00 am
11:00 am – 12:00 pm
23. PA Department of Health Update
Ms. Black, Mr. Koltash, Mr. Snyder
Join us to explore the issues that were addressed by the Pennsylvania Department of Health during the past year and that are expected to remain of prime importance in 2019. Find out about implementation of any recently enacted legislation and any forthcoming promulgation of new and revised regulations.
24. Medicaid Managed Care: Past, Present & Future
Mr. Chu, Dr. Fliszar
Attend to hear the statutory authorities for implementing mandatory Medicaid managed care as well as the original implementing regulations. We will discuss the proliferation of Medicaid managed care, and cover sections of the 2016 Medicaid Managed Care Final Rule, which is still being rolled out. We will conclude by discussing the use of Medicaid managed care for Medicaid expansion during the Obama and Trump eras, including an overview of the litigation and controversy over Medicaid work requirements.
25. Safeguarding the Bioeconomy: Challenges to Data Security, Health and National Security
The failure to recognize health-related data as a driver for the U.S. bioeconomy and therefore a national security concern has allowed foreign entities to gain significant access to U.S. genomic data, biological samples and other health-related data through research partnerships, contracts, investments, mergers, and acquisitions. This access could be used to support and accelerate a foreign competitor’s own bioeconomy in areas such as precision medicine and pharmaceutical development efforts. This also presents an alternative and more concerning perspective on the growing interest and targeting of health data by hackers. This presentation will focus on the need to better safeguard the U.S. bioeconomy and how not doing so would undermine existing international trade agreements and patent law and would represent a significant, existential national security threat to the U.S. economy and research and development efforts.
26. Negotiating Boilerplate Provisions in Healthcare Transactions and Other Healthcare Commercial Contracts
Ms. Hepp, Ms. Schreiber
Come to learn the negotiation of boilerplate provisions in healthcare transactions and other healthcare commercial contracts. We will discuss typical boilerplate provisions and the interaction between these provisions and the other substantive provisions in an agreement. Specifically, we will address areas where contradictory provisions (such as the exercise of remedies and limitation of liabilities) can result in unintended consequences for the parties.
27. Strengthening Compliance to Avoid Management’s Liability for Opioid Diversion
The government may turn to the Responsible Corporate Officer (“RCO”) doctrine to prosecute health system or pharmaceutical company executives for failure to detect opioid diversion, given the current opioid crisis in the United States. Making disclosures about individuals for diversion as required to earn “cooperation credit” with the DOJ creates a dilemma for management in light of the RCO doctrine. In February 2017, the DOJ released compliance program guidance that provides resolution to this dilemma. Bolstering compliance to detect and prevent diversion of opioids could preclude charges on a RCO prosecution theory.
12:00 – 1:15 pm
Lunch for all attendees
1:15 – 2:15 pm
28. Shut Off the Faucet and Stop Mopping the Floor: Handling the Current Healthcare Mess
Explore how our current health care system delivers such low value for the monies we spend. Examine the key concepts of population health and population health management. Take away predictions as to how care will be disrupted via patient engagement and through implementation of the tenets of population health into the delivery system.
2:15 – 2:25 pm
2:25 – 3:25 pm
29. Thinking Straight about Mental Health Coverage – PA Insurance Department Perspective
Mr. Mendelsohn, Ms. Ykema
Mental health and substance use coverage – what is parity and how may you identify it? Parsing parity in treatment limitations and financial requirements. Nine years after enactment, what questions about the Affordable Care Act are still up in the air?
30. Wellness Centers
More and more workplaces are including wellness centers and wellness activities as part of the employers efforts to maintain a healthy and productive workforce. These efforts are laudable but come with added requirements on the employers to maintain measures that will safeguard the information gathered in these environments. Complying with HIPAA and state privacy laws generally and breach notification laws in particular are challenging for many companies, including healthcare organizations, and has become more so in recent months as the GDPR and other laws have imposed yet more stringent obligations in this area. In particular, we will review: • The breach reporting obligations under HIPAA • FDA regulations • The FTC Act • The EU GDPR • Related legal obligations at the state level.
31. Due Diligence in Healthcare Transactions: Looking Under the Hood to Avoid Expensive Compliance Disasters
Mr. Joseph, Mr. Peck, Mr. Mattioli (moderator)
Health care transactions are at an all-time high. Once the deal is done, any latent compliance issues that are brewing at the just acquired entity are now yours! Take away suggestions for making the due diligence process successful. Topics include: • Knowing the inter-relationship between diligence, compliance and operating an acquired business • Diligence requires more than checking the boxes – helping the client understand the business implications of what you find • How to assess the impact on the value of the deal versus the necessary compliance steps • Strategies to effectively evaluate risks that may be faced post-closing.
32. Interesting Ethical Issues That Arise in Healthcare Transactions (ETHICS)
This interactive presentation will consist of several “real” ethical issues and questions that have arisen in connection with a variety of healthcare transactions and challenge the audience to determine how they were (or were not) resolved. Audience participation is encouraged.
33. Hospital-Physician Exclusive Agreements: New Developments!
As more and more community hospitals join health systems, there is an increased interest by the health system to explore having one group of providers serve as the exclusive provider of a particular service in all of the Health System’s hospitals. Sometimes the exclusive providers are health system employees, but often they are an independent group. Come to explore the legal as well as the practical issues that often arise with such transactions. Examine recent legal developments that will affect the terms that should be included in hospital exclusive agreements.
3:25 – 3:35 pm
3:35 – 4:35 pm
34. The Prosecution and Defense of a Healthcare Professional License Discipline Action
Mr. Dearden, Ms. Guilfoyle
Join us for a discussion on: • How Board investigations begin • Representing the professional during an investigation • Types of discipline • Collateral consequences when discipline is imposed • Consent agreements and orders • Professional health monitoring • Formal charges • Preliminary motions/ answers and new matter • Potential defenses • Prehearing procedures • The formal hearing • The adjudication • Appeal issues.
35. New Developments in the Opioid Epidemic
Mr. Moak, Dr. Snyder
Dr. Richard Snyder, Senior Vice President and Chief Medical Officer of Independence Blue Cross, and Douglas Moak, counsel in the Independence Blue Cross legal department, will discuss the clinical bases and legal implications of new developments in the opioid epidemic in Pennsylvania, focusing on developments in addiction prevention, accountable use of opioids, options for helping opioid-addicted patients, and crisis/overdose response. Audience participation and discussion will be encouraged.
36. The European Union’s General Data Protection Regulation: Its Impact on US Healthcare and What You Need to Know
Ms. Fischer, Ms. Rakoski
The European Union’s General Data Protection Regulation (“GDPR”) took effect this year, drastically impacting the collection, processing, storage, and use of data related to a European Union data subjects. Any entity that processes data related to an EU data subject will be required to comply with the granular technological, administrative and legal requirements laid out in the GDPR. We will discuss the global impact of the GDPR on the collection, processing, and storage of health-related data, including a comparison of the requirements for security and privacy under HIPAA and the HITECH Act, with a comparison to the requirements of the GDPR.
37. What’s Good for GM…? Self-Funded Health Plans
Ms. Gifford, Mr. Leeds
In the fall of 2018, General Motors announced that it had entered into an arrangement with the Henry Ford Health System to provide health benefits to 24,000 salaried employees in Southeast Michigan. Recent years have seen other employers with self-funded health plans contract directly with providers for services at discounted rates. We will: • Address the emergence and motivating forces behind these employer-provider relationships • Explore legal and practical issues in these relationships • Consider relevant contracting strategies • Take into account employer, provider and third party administrator perspectives.
38. Tax Reform, Reaction and Reinterpretation: A 2018-19 Tax Update for Healthcare Lawyers
Attend to hear an update of various tax issues and developments affecting the healthcare industry, and, specifically, tax-exempt healthcare providers. The topics will be based on the most recent developments over 2018 and early 2019 including the following: • Interpretation, application and impact of federal tax reform legislation • Recent federal income tax cases, rulings and other developments • Section 501(r) compliance/audits • IRS Form 990 and other procedural updates • Pennsylvania state/local tax developments.