The event of the year for every health law professional
The Institute Kicks Off with the Always Popular “Year in Review”
Take this opportunity to stay on top of all of the significant developments in health law in our opening session. In this energetic discussion you will be taken on a journey through all of the new and important case law and regulatory changes by Charles Artz, Barbara Blackmond and Nancy Bonifant Halstead. 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
Explore the Sweeping Changes to the Anti-Kickback and Stark Law Regulations
OIG and CMS have proposed changes to the Anti-Kickback Safe Harbors, the beneficiary inducement prohibition exceptions and the Stark Law regulations. Join Nicole Aiken-Shaban, Mark Mattioli and Karl Thallner as they examine how the changes will affect structuring arrangements and compliance counseling. Take away tips on how to address violations.
Are You Ready for the Future – Artificial Intelligence
How will artificial intelligence redefine care delivery? Eric Fish, John Harris, René Quashie and Dale Van Demark will address the most promising AI innovations redefining care delivery. Examine the legal issues involved in AI innovations including: the role of physicians, malpractice, evolving industry standards, data ownership and privacy, bias in algorithms and cybersecurity.
The Much Anticipated False Claims Act Update
Courts are continuing to release False Claims Act decisions at a brisk pace. Gregory David, Chief of the Civil Division, U.S. Attorney’s Office, Eastern District of PA, Pamela Coyle Brecht and Matthew Hogan will examine the recent decisions. You’ll hear each panelist’s point of view on these cases.
Keynote Address: How Life Sciences Changes the World (Including the Legal)
Author, Academic and Futurist, Juan Enriquez is a business leader recognized as one of the world’s leading authorities on the economic and political impacts of life sciences.
Juan Enriquez is one of those unique individuals who lives in the future and works on the cutting edge of discovery. He is an active investor in early-stage private companies in the life sciences sector, and is one of the world’s leading authorities on the uses and benefits of genomic research. Bioscience is beginning to affect the way we live, work and do business, and Juan is an articulate and effective advocate of its promise.
He thinks and writes about the profound changes that genomics and brain research will bring about in business, technology, politics and society. He will explore how the ability to understand, edit and write life code will change every aspect of our lives. Here is your opportunity to hear from a thought leader!
Juan Enriquez thinks and writes about the profound changes that genomics and brain research will bring about in business, technology, politics and society.
Jim Sheehan is back with a fascinating discussion on Conflicts of Interest in Health Care Organizations
What lessons can be learned from three recent cases – Memorial Sloan Kettering, the University of Maryland Health System, and the University of California San Diego? Jim Sheehan will examine the ethical implications of conflicts of interest. He will review the law, regulations and policies governing management and reporting of conflicts, the risks to organizations and best practices. Always an Institute favorite!
Returning This Year! Basics Bootcamp
Tuesday, March 10, 2020
A Day-long Health Law Refresher to Kickoff the 2020 Institute
We heard you! The Basics Track is now Basics Bootcamp. A full-day refresher with longer, in-depth sessions, more topics and 6 credits for only $99.
Build a solid foundation for your clients and your practice with sessions about:
- Health professional licensure in PA
- Health care facility licensure in PA
- Long term care issues
- Medical staff issues
- Third party payments
- Medicare/Medicaid fraud and abuse
- HIPAA privacy
- HIPAA security
Wednesday, March 11, 2020
8:35 – 10:05 am
The Health Law Year in Review
Mr. Artz, Ms. Blackmond, Ms. Halstead
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 regulatory updates. They will also offer their insights into the trends in health law and what lies ahead in these areas.
10:30 am – 12:00 pm
1. Regulatory Sprint to Coordinated Care Delivers Changes to Federal Fraud and Abuse Regulations
Ms. Aiken-Shaban, Mr. Mattioli, Mr. Thallner
OIG and CMS have proposed sweeping changes to Anti-Kickback Safe Harbors, the beneficiary inducement prohibition exceptions, and the Stark Law regulations. The proposals include expansive new rules aimed at reducing barriers to value-based arrangements and other consequential new interpretations and regulatory changes meant to clarify and reduce the burden of compliance with the Stark Law. We will focus on how the changes will affect structuring arrangements, compliance counseling and addressing violations.
2. Artificial Intelligence in Health Care – Get Ready for Transformation
Mr. Fish, Mr. Harris, Mr. Quashie, Mr. Van Demark
Explore how artificial intelligence will redefine care delivery and disrupt traditional business models. AI will address all phases of care delivery from wellness coaching to diagnosis and treatment, likely changing the role of physicians. AI will also transform business models, empowering consumers for smarter shopping and giving employers, insurers and consumers tools to overcome their frustrations with traditional healthcare providers. With these AI innovations will come a bevy of legal issues, including: the role of physicians, malpractice, evolving industry standards, data ownership and privacy, bias in algorithms and cybersecurity. We will discuss the most promising AI innovations, potential partnership or vender options, developing regulatory structures and key legal considerations.
3. 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!
1:15 – 2:15 pm
4. HIPAA Privacy and Security Enforcement
Mr. Artz, Ms. Ballay, Mr. Mayernick, Ms. Welch
Join us for a survey of all of the 2019 cases involving fines and sanctions relating to HIPAA Privacy and Security published by the Office for Civil Rights. One of the most significant decisions is an appeal pending in the Fifth Circuit U.S. Court of Appeals. This case resulted in a fine on the Covered Entity even though the misconduct at issue was caused by a third party criminal theft and employee noncompliance with the employer’s policies and procedures. There have been other significant OCR settlements and published federal and state court cases that will be discussed.
5. Finding the Value in Value-Based Contracts
Ms. Gopal, Mr. Rotella
Come to learn how to negotiate managed care contracts on behalf of health care providers with commercial payors that include value-based elements. Some of the issues include: • shared savings arrangements • quality incentives • privacy law considerations • antitrust concerns • attribution of patients to providers for performance measurement purposes • payment mechanics, including upside and downside provider risk, care coordination fees, and the timing of supplemental payments • key contract provisions, such as termination rights, rights to recoup by offset, and incorporation of general payor policies and procedures into value-based contracts.
6. Ethical Considerations in Asserting Attorney-Client Privilege in Compliance Investigations (ETHICS)
Ms. Lawrence, Mr. Wachlin
Asserting the attorney-client privilege over materials developed during compliance investigations raises a number of ethical issues. We will review the relevant PA Rules of Professional Conduct and the contours of the attorney-client privilege based on the relevant statute of case law.
7. Patient Data in Today’s Evolving Health Care Arena: Practical Risk Considerations and Exposure
Mr. Contreras, Mr. Rostolsky
With the advent of the General Protection Data Regulation (GDPR) and the California Consumer Privacy Act (CCPA), in addition to the continuing impact of HIPAA, the manner in which businesses and providers interact with patient data can feel like a minefield. We will focus on the practical concerns associated with accessing, managing, and storing patient data in light of the often logistically challenging regulatory prohibitions that are often at odds with business practicalities.
8. Representing the Healthcare Practitioner in the Opioid Epidemic
Ms. Dietrich, Ms. Nandan, Mr. Russo
In today’s climate of strong enforcement and criminal investigations in the medical field, it is critical for health law attorneys to be able to identify the issues involved in (or that may arise from) a government investigation. We will discuss the civil, criminal and licensure ramifications that flow from scrutiny of a client’s practice.
2:25 – 3:25 pm
9. Contract Providers and Traps for the Unwary
We will discuss the Reginelli case and its implications for sharing peer review information with contracted providers. We will also explore whether a recent California case, Economy v. Sutter East Bay Hospitals and its million dollar jury verdict, is a creature of California law or whether hospitals in Pennsylvania should be concerned if a hospital enforces a contractual provision that permits the hospital to instruct a contracted provider to remove a provider of a contracted service from the hospital without a hearing.
10. Transparency as a Primary Government Strategy in Health Care: Cheap but Ineffective
Government loves transparency. As a regulatory tool, it sounds good, is cheap to develop and implement and appears to give consumers market bargaining power. Transparency has value under some circumstances. But it is highly limited by informational deficiencies, patient cognitive biases and limitations, and provider limits. Health care is not a market in any sense, and information is most useful when the buyer has market power. Explore the multiple flaws in the government model of transparency, and develop some more profitable ways to improve both health care quality and cost control.
11. Telehealth 360
Attend to hear about: • telehealth’s enormous capability to increase quality, efficiency and access to care, and its implementation challenges • evolving state licensure issues, CMS and accreditation requirements for credentialing, privileging and peer review • the federal and commercial reimbursement environment • fraud and abuse issues in developing telemedicine service arrangements • regulatory, accreditation and business issues arising out of the use of APPs in telehealth.
12. Cyber Ethics: The Crossroads of Cybersecurity and Ethics
Mr. Chu, Mr. Fliszar
We will focus on a lawyer’s ethical duty to safeguard sensitive client information and steps to take if the lawyer experiences a breach of client information. We will address an attorney’s duties of confidentiality and competence in regard to securing client information, cloud computing concerns and recent ABA ethics opinions on securing client information and obligations after an electronic data breach.
13. How to Manage Physician Expectations of Private Equity Investment in Medical Practices
Mr. Schaff, Mr. Washlick
We will provide a real-world look at private equity investments in healthcare and what it means for providers and what advisors and attorneys need to know to counsel their clients. Topics include: • review of PE activity in healthcare space • PE business model – real world fact pattern case study • why are PE firms interested in medicine? • what does the influx of PE mean for physicians and other healthcare providers? • review of typical deal terms in PE transactions • examine restrictive covenants and liquidating and exit rights • regulatory issues presented by PE deals • legal traps and how to avoid them • planning considerations.
3:35 – 4:35 pm
14. Keynote Address: How Life Sciences Change the World (Including the Legal)
Just as the digital world fundamentally changed our lives, the ability to understand, edit, write life code will change every aspect of our lives. Juan Enriquez is one of those unique individuals who lives in the future and works on the cutting edge of discovery. He is an active investor in early-stage private companies in the life sciences sector, and is one of the world’s leading authorities on the uses and benefits of genomic research. Bio-science is beginning to affect the way we live, work and do business, and Juan is an articulate and effective advocate of its promise. Come to hear this engaging discussion on genomics!
Thursday, March 12, 2020
8:30 – 9:30 am
15. Life After Tax Reform: A 2019-20 Tax Update for Healthcare Lawyers
Attend to receive an overview of various tax issues and development affecting the healthcare industry and specifically, tax-exempt healthcare providers. The topics will be based on the most recent developments over 2019 and early 2020 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.
16. Research Law and Compliance 2019-2020 Year in Review
Learn about new research related laws, regulations, administrative guidance and enforcement cases from the last year: • OIG Workplan updates on research • DOJ/OIG enforcement cases in research • OHRD, ORI, FDA regulations and guidance • ways to incorporate these new laws, regulations and guidance into your research compliance programs.
17. A Revolution in the Offing? Individual Coverage Health Reimbursement Arrangements Take Their Shot
Mr. Leeds, Ms. Okafor
The newly minted Individual Coverage Health Reimbursement Arrangement could change the way many employers provide health coverage to their employees. The ICHRA allows an employer to determine a fixed dollar amount that it will contribute to an HRA to fund the payment of premiums for coverage that its employees purchase on the individual health insurance market. We will review the legal requirements that apply to ICHRAs, review whether this option will be attractive to physician practices and other employers and consider the effect of these new programs on relevant health insurance markets.
18. Managing Employment Challenges in the Age of the Opioid Epidemic
Ms. Flitter, Ms. Kirshenbaum, Ms. Rosenblum
Join us for a discussion on challenges associated with suspected diversion and impairment at work. We will explore when and under what circumstances institutions and licensees must report individuals to State and Federal authorities. Panelists will also offer guidance on approaching providers under these delicate circumstances while mitigating the risks of claims under the Family and Medical Leave Act and laws prohibiting disability discrimination.
19. Late Career Practitioner Policies: Patient Safety Initiative or Age Discrimination?
Advocates point out that as we all age, certain conditions are more likely to develop. Physicians may function in silos, with little opportunity to notice potential risk to patients until harm occurs, so a policy is a prudent patient safety protective tool. Others say that focus on age as a trigger for any scrutiny – even testing – violates the Age Discrimination in Employment Act, as more physicians become employed by hospitals and affiliates, and many are retiring later. Is the law and evidence supporting policies evolving?
9:45 – 10:45 am
20. PA DHS Update and Preparing for Your Long Term Care Future
Mr. Newell, Ms. Oakes
Attend to hear a brief update on recent matters of interest involving the Pennsylvania Department of Human Services. We will provide a more lengthy discussion of Medicaid long term care eligibility requirements. Following this session, you will be older, closer to your long term care future, and hopefully wiser and better able to help your family, friends and clients navigate the long term care system.
21. A Diverse and Inclusive Community of Health Lawyers: Strategies for In-House Counsel and Law Firms (ETHICS)
Ms. O’Rourke, Ms. Stevenson
Take a deep dive into strategies to improve diversity and inclusion in both the in-house legal department and law firm settings with particular attention to the health care industry. We will discuss the current status of diversity and inclusion in the legal field, how diversity and inclusion improves the effective delivery of legal advice to internal and external clients, share proven and cutting-edge partnerships between in-house counsel and their law firm partners to move the needle on parity in the legal profession, and provide metrics to measure success. You will leave with new ideas, practical strategies and tactics to impact diversity and inclusion in your own workplace.
22. Paying Physicians for Cancer Care
Cancer care has been paid for under a perverse model where physicians make money on the discounts on drugs given to them by pharmaceutical companies, rather than being paid for the complex services they provide to patients, most of which are not recognized by most payors, and tops among them Medicare. Medicare institutes a new model of payment, Oncology Care Model, two years ago, but it has not been well received by most physicians. As the baby boomers age, cancer care will become a bigger portion of the health care spend. How we got where we are and where we are headed is worth considering in an organized way.
23. Corporate Minutes for Healthcare Entities – Who, What, When, Where and Why and Best Practices
Ms. Hepp, Ms. Schreiber
We will address best practices for corporate minute taking on the board of director level, board committee level, and for internal department meetings. Specifically, we will discuss the format for taking minutes, what is required to be included and what should be omitted and the reasons for inclusion or omission. Finally, we will address the risks associated with improper minute taking.
11:00 am – 12:00 pm
24. PA Department of Health Update
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 2020. Find out about implementation of any recently enacted legislation and any forthcoming promulgation of new and revised regulations.
25. Update on NJ Cannabis Law
Attend to gain valuable insights and strategies for handling many of the new situations that will likely arise as a result of the NJ Cannabis Law. Explore the most impactful issues and take away guidelines and practical tips for your practice. Come to get your questions answered!
26. Best Practices for In-House Counsel and Litigators in Dispute Resolution
Mr. Drucker, Mr. Jacobs, Ms. Meyer
This interactive program covers step-by-step how to use mediation and arbitration to address fact patterns drawn from real health law cases. Learn how to build effective conflict resolution tools into relationships between health care organizations and apply these tools when tensions mount.
27. Preparing for the Fight of Your Life: Anatomy of a Healthcare Fraud Prosecution
How should healthcare attorneys and their clients prepare when facing a criminal and/or civil false claims prosecution? Key issues include: • the pre-indictment and the Grand Jury process • the battle of expert witnesses on coding, compliance, medical and Daubert issues • the government’s use of peer-comparison evidence • what standard governs the billings in dispute, the CPT codes, or some other “clinical criteria” • evidence of intent and the “Good Faith” defense • evidence of claims, procedures and other conduct not contained in the indictment • navigating the differences between the policies, rules and regulations of government and private insurance companies.
1:15 – 2:15 pm
28. Conflicts of Interest in Health Care Organizations: Not Just About the Money (ETHICS)
The complexity of roles and relationships in modern healthcare organizations require identification and management of conflict issues – for physicians, executives, board members, IRBs and government grantees. Three recent cases – Memorial Sloan Kettering, the University of Maryland Health System, and the University of California San Diego – will be used to review the law, regulations and policies governing management and reporting of conflicts, the risks to organizations and best practices.
2:25 – 3:25 pm
29. The Affordable Care Act’s Impact on Health Insurance in Pennsylvania
Ms. Beam, Mr. Hendrickson, Ms. Ykema
Come to hear about: • Pennsylvania’s new State- Based Exchange and Reinsurance Program • the current landscape in PA of ACA insurance reforms designed to make adequate and affordable health insurance accessible to nearly everyone, including regulatory and judicial efforts to undermine them • the gains that have been made and the road ahead.
30. The Good, Bad and Ugly of Cloud Service Provider Contracts
Ms. Klein, Mr. Pennington, Ms. Titterton
Join us for a discussion on: • how cloud service provider agreements really work • the pitfalls to watch out for • practical tips in navigating negotiations with cloud vendors in the highly regulated healthcare environment. Learn strategies to better protect and control data use by third party cloud vendors.
31. Risky Business – Advancing Your Assessments and Analyses Beyond that Old Time Rock and Roll
Mr. Beattie, Mr. Miller
Trends and surveys have demonstrated that many in-house counsel and compliance officers find that their risk assessment and analysis processes, foundational elements of effective compliance controls, are in need of improvement. Learn best practices and techniques for structuring and designing risk assessment and analysis processes, from initiating assessment workgroups to presenting final results and recommendations.
32. Surprise Billing: Can Plans Dictate Provider Prices?
Ms. Martin, Mr. Raphaely
Providers are seeing a rise in health plans that do no contract with providers, but offer payment to the provider based on a reference price (e.g. a percentage of Medicare) after the plans’ members are treated as these types of plans gain traction in the market. We will explain referenced based pricing, as well as the public perception and the political and legal realities facing providers who treat members of plans which utilize referenced based pricing. Providers will be armed with the information they need to navigate the complex intersection of surprise billing legislation, the ACA, the Fair Debt Collection Act and common law contract theory to preserve the integrity of their pricing structure.
3:35 – 4:35 pm
33. Navigating the Dilemma of Medical Marijuana: Practical Guidance for Facilities
Ms. Hein, Ms. Unger
Medical marijuana is currently legal in 33 states, including Pennsylvania, which is now in its fourth year of implementing its Medical Marijuana program, and New Jersey, which recently overhauled and dramatically expanded its Medical Marijuana program. Despite the rapid expansion of state programs, the federal government has not changed its position on marijuana’s Schedule I status under the CSA. The conflict between state permission and federal prohibition leaves health care facilities reliant on Medicare and Medicaid funding in a difficult position. We will focus on practical guidance for facilities balancing the conflicting dictates of the state and federal regimes.
34. Conscience Protections in Healthcare: Current Legal Issues
Mr. Chopko, Ms. Gniady
Navigating the legal issues surrounding the protections for conscience in the healthcare industry is rarely straightforward. Current trends include increasingly detailed regulations and ongoing litigation seeking the right balance between faith and healthcare. This matter is complicated by the radical differences in approach between Administrations. Using recent regulations and litigation results, we will examine the effects on healthcare entities (both religious and secular), employees in healthcare, and implications for larger transactions across the industry.
35. Digital Health: Navigating the Reimbursement Landscape
Mr. Bowers, Ms. Petrillo
As digital health platforms become more prevalent, digital health providers will need to navigate the regulatory environment applicable to both governmental and private payors in order to be reimbursed for their services. We will discuss the relevant laws, as well as the contracting and payment issues that such providers will face.
36. How Ambulance Contracts Can Drive Facilities into Non-Compliance
Mr. Brody, Mr. Wolfberg
DOJ has applied the False Claims Act to facilities that order ambulance services – even though the facility’s contracted ambulance service submits the claims for services. This new “throughput” theory of liability is an emerging FCA concern for facilities, and we will review these recent actions. Also, facility arrangements with ambulance and medical transport providers pose significant risks under the anti-kickback statute and we will review key cases and advisory opinions in that context.
Create your own program - so many great topics
The Institute offers so many breakout session options, addressing significant health law topics from numerous angles - all designed to provide you with information and practice tips to make you better at what you do. Tailor a program to your specific needs by selecting the sessions that matter to you and your practice. This is just one of the many features that make this Institute an outstanding investment of time in your professional development.
Ankura Consulting Group, LLC
Buchanan Ingersoll & Rooney PC
Duane Morris LLP
Pepper Hamilton LLP
Post & Schell, P.C.
Thomas Jefferson University
Fox Rothschild LLP
Greenberg Traurig LLP
Horty Springer & Mattern
Morgan Lewis & Bockius LLP
Reed Smith LLP
Pietragallo Gordon Alfano Bosick & Raspanti LLP
Stevens & Lee, P.C.
Each day of this Institute has been approved by the Pennsylvania Continuing Legal Education Board for 6 hours of CLE credit. Workshop choices will determine whether credits are in substantive law, practice and procedure or ethics, professionalism or substance abuse.
All attendees will receive the course materials as a digital book. A printed copy of the course book is available, at a discount to attendees, for $80. Additional copies are available at full price. If you wish to purchase the printed version of the course book, please call PBI Customer Service at 800-932-4637. Printed versions of the course book will not be distributed at the course; please allow up to two weeks after the program for the printed versions of the course book to be shipped.