12 CLE CREDITS INCLUDING ETHICS | 14 CPA CREDTIS | 12 NURSING HOME ADMINISTRATOR CREDITS

24TH ANNUAL HE ALTH L AW INSTITUTE The event of the year for every health law professional!

GREAT REASONS 5 TO ATTEND 1. Get the latest word on what’s happening at HHS from current Deputy Secretary of HHS Eric Hargan.

2. Highly sought after speaker and leading expert and researcher on health care management and economics, Professor Van Horn, delivers Tuesday’s keynote address.

3. Choose the topics that matter most to you and your clients – over 48 different topics!

4. Take away impressive Institute materials that you’ll refer to time and time again. 5. Enjoy networking with your TUE. & WED., MAR. 13 & 14, 2018 colleagues at the Safe Harbor PA CONVENTION CENTER, 12TH & ARCH STREETS Reception! 8:30 am to 4:35 pm; check-in and continental breakfast begin at 7:45 am each day 24TH ANNUAL HE ALTH L AW INSTITUTE

ith so many changes on the horizon, the Health Law Hear directly from Eric WInstitute delivers critical new content in a practical, Hargan, current Deputy well-rounded agenda. The Institute provides a place for Secretary at U.S. Health you to learn new information and insights on the most and Human Services important developments and practice challenges. Join Deputy Secretary Eric Hargan at us for this annual event where more than 400 health law HHS will be sharing his insights professionals gather for a rich educational experience – about the initiatives of the and the opportunity to network and socialize! Department. His remarks are sure to off er you and your The Institute kicks off with the always clients a new perspective on the role of HHS now and in popular “Year in Review” the months ahead. This session kicks off Wednesday’s sessions – you won’t want to miss hearing what Deputy Take this opportunity to stay on top of all of the Secretary Hargan has to say. significant case law developments and regulatory changes in health law in our opening session. In this Special Guest Speaker: energetic hour you will be given a journey through Professor Van Horn all of the new and important case law and regulatory on the Changing developments by Charles Artz, Barbara Blackmond and Healthcare Customer Mark Gallant. It’s the perfect way to explore what is The healthcare conversation in happening across a broad spectrum of health law issues. the US has been dominated by You’ll also get a glimpse at what is on the horizon in government health care policy. Relatively little attention health law. has been paid to changes in the private sector and how this will aff ect the future of health care provision. The dynamic and engaging Professor Van Horn will contrast government initiatives around the ACA with the “You receive invaluable evolving posture of employers with respect to health interaction with state and benefits. This change has resulted in a new healthcare customer – the individual consumer. How must health federal regulators!” care providers think about their business diff erently? How will health law be impacted? Professor Van Horn will challenge the way you think about the future of health law. Professor Van Horn’s remarks will be followed immediately by the Safe Harbor Cocktail Reception – join us!

2 HE ALTH L AW An unparalleled opportunity to be updated on the most significant health law developments of the year and what is trending!

The much anticipated False Claims Act Alice Gosfi eld addresses Update is back one of the hottest issues in health law Courts are continuing to release False Claims Act decisions at a brisk pace. You’ll hear each panelist’s Physician leasing has become viewpoint on the latest cases. Our stellar panel includes one of the hot button issues in Margaret Hutchinson, Chief of the Civil Division of the US health law. Join Alice Gosfield to Attorney’s Off ice, Eastern District of PA; David Laigaie and find out why leasing has become Matthew Hogan. Come to hear the insightful banter and such a big issue and how the landscape is changing. Are to be updated on all that’s new! restrictive covenants necessary? How do you handle the introduction of new physicians? Who owns the records? Tips for medical staff leaders and counsel Gosfield will answer these and many more questions who advise them about this important area of health law practice. Guaranteed to be a crowd pleaser! Do you advise medical staff leaders? If so, this Super Workshop is one you’ll want to attend. In a lively Jim Sheehan looks at discussion, Barbara Blackmond and Linda Haddad will “Reporting Up” to the fill you in on the most significant issues for medical “Highest Authority that staff leaders. The issues are getting more and more Can Act on Behalf of the complicated each year. Take away tips that will help you Organization” and your clients navigate these complex issues more eff ectively. How should lawyers act when they believe that corporate agents Be updated on all that’s new in engage in actions or refuse to engage in actions which health care reform violate the legal obligations of the organization? Join Jim Sheehan to examine the ethical duties and options Our outstanding panelists, Mark Gallant, Laval Miller- for attorneys with knowledge of actual or potential Wilson and Sandra Ykema, will not only off er the illegal conduct by the organization or its agents in this absolute latest information about healthcare reform, thought-provoking ethics hour. but will break down how it will impact your clients. The health care provider, consumer and commercial insurance perspectives will all be provided. “I love that there are sessions on so many current and developing topics.”

3 TUESDAY’S SCHEDULE MAR 13

8:30 – 8:35 Welcome

8:35 – 10:05 The Health Law Year in Review MR. ARTZ, MS. BLACKMOND, MR. GALLANT

10:05 – 10:30 Break

1 SUPER WORKSHOP 2 SUPER WORKSHOP False Claims Act Update Hot Topics for Medical Staff Leaders Mr. Hogan and Counsel Who Advise Them Ms. Hutchinson Ms. Blackmond Mr. Laigaie Ms. Haddad

10:30 – 12:00 3 JUST THE BASICS 10:30 – 11:00 4 JUST THE BASICS 11:00 – 11:30 5 JUST THE BASICS 11:30 – 12:00

Fundamentals of HIPAA Privacy The ABCs of HIPAA Security Submission and Payment of Claims Ms. Kornrumpf Mr. Shay Ms. Brancatella

12:00 – 1:15 Lunch for all attendees

6 7 ETHICS 8 9 10 11 Inside the OCR Codes of Conduct: Representations Beyond Repeal: What Is Happening Changing Horses: Investigation/Audit Do They Really and Warranties Developments for in NJ Health Law Legal and Practical Process Prevent Unethical/ in Healthcare Health Benefit Plans Issues Surrounding Ms. Palestini Illegal Conduct? Transactions under the Aff ordable Electronic Health Dr. Fliszar Care Act Record (EHR) Ms. Holland Mr. Hoff man Ms. Hepp Transitions Ms. Smith Ms. Schreiber Ms. Giff ord Mr. Leeds Mr. Shay 1:15 – 2:15

12 JUST THE BASICS 1:15 – 1:45 13 JUST THE BASICS 1:45 – 2:15

Health Care Facility Licensure in Pennsylvania Medical Staff Issues Ms. Johnson Ms. Nagele

2:15 – 2:25 Break

14 ETHICS 15 16 17 18 19 To Disclose or Not to Informed Consent The Business Antitrust Law: Scenes from Blockchain and Disclose: Is It Ever a Aft erShinal Implications of What’s New? a Medical Staff Healthcare Privacy Question? Health Reform Hearing Laws Just Don’t Mix Mr. Ryan Mr. Honart Mr. Mustokoff Mr. Harris Mr. Bubba Mr. Guagliardo Mr. Thallner Ms. Shields Ms. Klein 2:25 – 3:25 20 JUST THE BASICS 2:25 – 2:55 21 JUST THE BASICS 2:55 – 3:25

Basics of Medicare/Medicaid Fraud & Abuse Fraud & Abuse Compliance Mr. Sokolow Mr. Sokolow

3:25 – 3:35 Break

KEYNOTE ADDRESS

The Changing Healthcare Customer: What It Means for US Healthcare PROFESSOR VAN HORN 3:35 – 4:35

4:35 – 5:30

JOIN US! The “Safe Harbor”Reception You are invited to a relaxing and enjoyable reception immediately following the keynote address by our special guest speaker, Professor Van Horn. Enjoy great food and drink with the music of The Mélange Collective Jazz Trio in the background. It’s the perfect way to unwind and visit with your colleagues at the end of the day.

4 WEDNESDAY’S SCHEDULE MAR 14

8:30 – 9:30 News from Washington: What’s Happening at HHS CURRENT DEPUTY SECRETARY HARGAN, HHS

9:30 - 9:45 Break

1 SUPER WORKSHOP 2 SUPER WORKSHOP 24 25 26 SUPER WORKSHOP 27 28 False Claims Act Update Hot Topics for Medical Staff Leaders Recent 2018 Research Law Healthcare Reform: State and Federal Successful Integration Developments at in Review How the Landscape Is Changing Criminal and Civil and Use of Advanced Mr. Hogan and Counsel Who Advise Them the PA Department Enforcement Priorities Practice Professionals Ms. Murtha Ms. Hutchinson Ms. Blackmond of Human Services Mr. Gallant in Healthcare in 2018: (APPs) Mr. Laigaie Ms. Haddad Mr. Miller-Wilson A Discussion Ms. Grogan Ms. Ykema Ms. Nagele 9:45 - 10:45 Ms. Leisch Ms. Fullmer Ms. Sher 3 JUST THE BASICS 10:30 – 11:00 4 JUST THE BASICS 11:00 – 11:30 5 JUST THE BASICS 11:30 – 12:00 Ms. Leahy Ms. Malone Fundamentals of HIPAA Privacy The ABCs of HIPAA Security Submission and Payment of Claims Mr. Raphael Ms. Kornrumpf Mr. Shay Ms. Brancatella 10:45 - 11:00 Break 12:00 – 1:15 Lunch for all attendees 29 30 SUPER WORKSHOP 31 32 33 6 7 ETHICS 8 9 10 11 Community Health Lessons Learned What’s the Future The Opioid Epidemic Living with MACRA Inside the OCR Codes of Conduct: Representations Beyond Repeal: What Is Happening Changing Horses: Choices and the New from Physician Leasing of the CMS 60-Day in Pennsylvania: (The Medicare Investigation/Audit Do They Really and Warranties Developments for in NJ Health Law Legal and Practical Federal Medicaid Overpayment Rule – Top 10 Legal Access and CHIP Process Prevent Unethical/ in Healthcare Health Benefit Plans Issues Surrounding Managed Care Rules Ms. Gosfield Can Negligence Considerations Reauthorization Act Ms. Palestini Illegal Conduct? Transactions under the Affordable Electronic Health Really Trigger for Health Care of 2015) and Value Dr. Fliszar Mr. Cherry Care Act Record (EHR) False Claims Act Providers Based Payments in Ms. Holland Mr. Hoffman Ms. Hepp Mr. Hancock Transitions 11:00 - 12:00 Exposure? the Real World Ms. Smith Ms. Schreiber Ms. Gifford Ms. Leisch Mr. Moak Mr. Leeds Mr. Shay Ms. Hein Mr. Mattioli Ms. Rowland Dr. Moses 12 JUST THE BASICS 1:15 – 1:45 13 JUST THE BASICS 1:45 – 2:15 Mr. Sherry

Health Care Facility Licensure in Pennsylvania Medical Staff Issues 12:00 - 1:15 Lunch for all attendees Ms. Johnson Ms. Nagele 34 35 36 ETHICS 37 38 39 2:15 – 2:25 Break Hot Issues in Health Smashing into Being Professionally Stark Self-Disclosure Community Health Beyond the Insurance from the Windows: The Responsible in Protocol—Do New Choices: Using Financial Terms: 14 ETHICS 15 16 17 18 19 Insurance Regulator Limits of Consumer a Sometimes Rules Indicate a New Managed Care to Understanding Perspective Sovereignty in Irresponsible Attitude? Deliver Medicaid- Key Legal Issues To Disclose or Not to Informed Consent The Business Antitrust Law: Scenes from Blockchain and Health Care Healthcare World Funded Long-Term in Payer-Provider Mr. Mendelsohn Mr. Casale Disclose: Is It Ever a After Shinal Implications of What’s New? a Medical Staff Healthcare Privacy Services and Contracts in 2018

1:15 - 2:15 Ms. Ykema Prof. Furrow Ms. Benesch Question? Health Reform Hearing Laws Just Don’t Mix Supports (LTSS) in Mr. Ryan Mr. Honart Mr. Wax Mr. Raphaely Mr. Mustokoff Mr. Harris Mr. Bubba Mr. Guagliardo Pennsylvania Mr. Thallner Ms. Shields Ms. Klein Mr. Miller-Wilson Ms. Torregrossa 20 JUST THE BASICS 2:25 – 2:55 21 JUST THE BASICS 2:55 – 3:25 2:15 - 2:25 Break Basics of Medicare/Medicaid Fraud & Abuse Fraud & Abuse Compliance Mr. Sokolow Mr. Sokolow 40 41 SUPER WORKSHOP | ETHICS 42 43 44

3:25 – 3:35 Break PA Department of Advice for Lawyers Considering Regulatory Implications of Tax Issues One Call Away: Health Update “Reporting Up” Information about Various Hospital Service Impacting Healthcare Configurations – An Update Tax-Exempt Telephone KEYNOTE ADDRESS Mr. Koltash Illegal Conduct “To the Highest on Provider-Based Status, Healthcare Consumer Ms. Leshko Authority” Co-Location Arrangements Organizations Protection Act

2:25 - 3:25 Mr. Snyder and Micro Hospitals (TCPA) Class Mr. Sheehan Mr. Hennessey Actions Ms. LaManna Ms. Raleigh Mr. Rosenthal

3:25 - 3:35 Break

45 46 47 48 49 New LLC Law in PA: Telemedicine The Regulation of Medical Clinical Laboratories: Advancing Value- How Is It Changing the Implementation: Marijuana Under Federal They’re Back Under Based Contracting for Structure of Healthcare Do’s and Don’ts and Pennsylvania Law the Government Prescription Drugs and Entities and Whistleblower’s Medical Devices

3:35 - 4:35 Mr. Quashie Mr. Goldberg Microscope Mr. Hoy Ms. Rosenthal Mr. Bassman Ms. Jacobs Ms. Brecht Mr. Boise

5

“This program is one of PBI’s best, actually it is THE BEST!” SESSION DESCRIPTIONS

provider risk. Explore common payment concerns • the effect of Allstate Insurance Company v. MAR including the process for submitting claims, prompt Northfield Medical Center, P.C. on captive PC payment, overpayment recovery, coordination of structures and management services • the new Tuesday benefits, and emerging regulatory issues related to (effective February 1, 2018) exception to the Codey 13 value based payments. Law prohibition against physician self-referrals for alternative payment models (“APMs”). 1:15 pm – 2:15 pm 8:35 am – 10:05 am 11. Changing Horses: Legal and Practical Issues Surrounding Electronic Health 6. Inside the OCR Investigation/Audit Process Record (EHR) Transitions The Health Law Year in Review DR. FLISZAR, MS. HOLLAND, MS. SMITH MR. SHAY MR. ARTZ, MS. BLACKMOND, MR. GALLANT Come to learn about important HIPAA compliance Discover the reasons why physicians change Don’t miss your chance to catch up on all of the updates from the past year, as well as how to EHRs, and examine common problems relating to important healthcare developments over the past prepare for a phase 2 audit or other investigations changing EHRs, including those relating to data year. Our dynamic panel will bring you the hottest by OCR. transfer, HIPAA concerns, and other issues. Consider developments related to physicians, hospitals and EHR license agreement provisions and how they can Affordable Care Act (ACA) litigation and reimbursement ETHICS affect this process. Take away practical suggestions developments. They will also offer their insights into the for navigating the transition from one EHR to trends in health law and what lies ahead in these areas. 7. Codes of Conduct: another. Do They Really Prevent Unethical/Illegal Conduct? am pm 10:30 – 12:00 MR. HOFFMAN JUST THE BASICS (1:15 – 1:45 pm) SUPER WORKSHOP The health care industry has a long history of implementing corporate compliance programs to 12. Health Care Facility Licensure 1. False Claims Act Update prevent and detect potential illegal conduct. Often in Pennsylvania MR. HOGAN, MS. HUTCHINSON, MR. LAIGAIE overlooked is the requirement that an “ethics” MS. JOHNSON program must play an important role in order for a The number of False Claims Act cases filed and Attend to understand the who, what and why of compliance program to be effective. This session settled continues to rise. Join our distinguished health care facilities licensure in Pennsylvania, will discuss recent unethical and illegal conduct in panel as they examine the most notable False including: • a breakdown of the main health care a variety of industries and will focus attention on Claims Act cases from the past year. The panel will licensing agencies • the relevant licensure laws and the value and effectiveness of Codes of Conduct also discuss major issues that have arisen—or that regulations • a discussion of cross-jurisdictional in accomplishing the mandates of corporate loom on the horizon—involving the FCA. Always a licensure issues • the interplay between federal compliance. lively discussion! reimbursement requirements and state licensure requirements. SUPER WORKSHOP JUST THE BASICS (1:45 – 2:15 pm) 2. Hot Topics for Medical Staff Leaders and Counsel Who Advise Them 13. Medical Staff Issues MS. BLACKMOND, MS. HADDAD “Health lawyers in the public and MS. NAGELE Join us for a lively discussion on: • medical staff private sectors gather together Take away an understanding of the unique implications of the opioid crisis • unification of medical oversight structure for physicians and medical staffs within hospitals in systems other professionals who practice in hospitals, • reorganization of hospital medical staffs to share information!” ACOs, CINs, clinics and large physician practices. • strategies to address physician burnout. Attend to learn: • federal and state regulatory and accreditation requirements • Medical Staff Bylaws, JUST THE BASICS (10:30 – 11:00 am) Rules and Regulations • Peer Review Privilege, 8. Representations and Warranties in Policies and Procedures • HCQIA Immunity and 3. The Fundamentals of HIPAA Privacy Healthcare Transactions NPDB Reporting • managing patient safety and MS. KORNRUMPF MS. HEPP, MS. SCHREIBER conduct. Learn about the HIPAA Privacy Rule in a post- Come to discover the importance of representations HITECH world. We will explore: • who must comply and warranties in healthcare transactions from with HIPAA/HITECH and what information HIPAA/ both the Buyer’s and Seller’s perspectives, including HITECH protects • the obligation of covered entities pm pm ways to minimize risk in transaction documents. 2:25 – 3:25 and business associates on the use and disclosure Examine the interplay between representations and of protected health information • the rights of warranties and indemnification. Explore options ETHICS individuals and their protected health information. for insurance to help address risk and bridge the 14. To Disclose or Not to Disclose: gap between representations and warranties and JUST THE BASICS (11:00 – 11:30 am) Is It Ever a Question? indemnification obligations. MR. MUSTOKOFF 4. The ABCs of HIPAA Security MR. SHAY 9. Beyond Repeal: Here is your chance to hear a discussion of trends in Developments for Health Benefit Plans health care fraud and abuse enforcement, and the Learn about the HIPAA Security and Breach Under the Affordable Care Act ethical questions these trends present to healthcare Notification Rules in a post-HITECH world. We will MS. GIFFORD, MR. LEEDS attorneys. Using the complex arrangements explore: • the obligations of covered entities and between pharmacies and physicians, salespeople business associates to secure protected health Whether or not any provisions of the Affordable and attorneys as a backdrop, we will address key information and electronically protected health Care Act are repealed or replaced, changes are issues that arise during healthcare investigations, information • the requirements of the breach coming. Come to acknowledge those changes, with including: • identifying the actual client • working notification rule • enforcement and penalties. a particular focus on how they affect the health with corporate counsel and deciding whether benefit plans of healthcare providers. JUST THE BASICS (11:30 am – 12:00 pm) to continue existing relationships with outside professionals • protecting the attorney-client 10. What Is Happening in NJ Health Law 5. Submission and Payment of Claims privilege • determining whether to enter joint MS. PALESTINI MS. BRANCATELLA defense agreements and when to divorce from Attend to hear about the developments in New alleged bad-actors • to disclose or not—fulfilling Hear the nuts and bolts of common compensation Jersey healthcare law, including: • opioids and the obligations to report alleged misconduct to methods under payer/provider contracts such as regulatory environment • healthcare facility and regulatory authorities. fee-for-service and capitation payments, and touch service licensure/certification updates and insights on the evolving world of value based payments and

6 15. Informed Consent After Shinal JUST THE BASICS (2:55 – 3:25 pm) 9:45 - 10:45 MR. RYAN 21. Fraud & Abuse Compliance Explore the wide-reaching effects of the PA 24. Recent Developments at the PA Department MR. SOKOLOW Supreme Court’s recent decision on informed of Human Services consent in Shinal v. Toms, including: • what exactly It is often said in sports that the best offense is a MS. GROGAN, MS. LEISCH is the holding of Shinal? • how must hospitals, good defense. By analogy, in the heavily regulated Hear an update on healthcare-related activities of physicians, and other healthcare providers adjust health law field, one of the keys to the successful the Department of Human Services in the past year. their informed consent policies and practices to growth and operation of any health care business Specific topics include: • changes to the home-and comply with Shinal? • how will Shinal affect the is a good corporate compliance program. Attend community-based waiver services for individuals litigation of informed consent claims? • will Shinal to learn the importance of health care compliance with physical disabilities or an intellectual disability be effective in achieving its stated goals? programs, how to establish them, implement them or autism • 2017-18 budget of Department programs and determine if they are operating effectively. • litigation against the Department in a variety of 16. The Business Implications of Health Reform Their potential impact on Medicare and Medicaid areas. MR. HARRIS, MR. THALLNER revenues will also be discussed. Just as we were getting comfortable with the 25. 2018 Research Law in Review regulations and strategies associated with the 3:35 pm – 4:35 pm MS. MURTHA Affordable Care Act, we face the continuing Come to understand all of the new laws, prospect of uncertain changes. We will address the KEYNOTE ADDRESS regulations, and agency guidance on research- business implications and legal considerations of related topics affecting research universities, 22. The Changing Healthcare Customer: up-to-the-minute ACA changes. We will focus on hospitals and institutes. We will also review What it Means for US Healthcare Medicare value-based payment models (ACOs and DHHS, PHS, and OIG enforcement initiatives in bundled payments), health insurance exchanges, PROF. VAN HORN clinical research as well as new litigation related and changes to Medicaid funding. The healthcare conversation in the US has been to research topics. Finally, we will identify how dominated by government health care policy. research organizations should address these new 17. Antitrust Law: What’s New? Relatively little attention has been paid to changes issues and initiatives. MR. HONART in the private sector and how this will affect the SUPER WORKSHOP Attend to hear the latest developments concerning: future of health care provision. The dynamic • provider-provider integration including health and engaging Professor Van Horn will contrast 26. Healthcare Reform: system mergers, health system/physician government initiatives around the ACA with the How the Landscape is Changing transactions, and physician group mergers evolving posture of employers with respect to MR. GALLANT, MR. MILLER-WILSON, MS. YKEMA • provider/payor integration • payor/payor mergers health benefits. This change has resulted in a new • joint ventures involving providers and payors. healthcare customer – the individual consumer. Join us to understand the changes that may How must health care providers think about happen with healthcare reform. We will share from 18. Scenes from a Medical Staff Hearing their business differently? How will health law be our perspectives concerning both government MR. BUBBA, MS. SHIELDS impacted? Professor Van Horn will challenge the programs and commercial insurance. We will walk way you think about the future of health law. you through the current state of the law and how it Experience a “re-enactment” of an internal hospital affects your clients. hearing in which a physician’s clinical privileges

and medical staff membership are at risk. The 27. State and Federal Criminal and Civil re-enactment will provide a procedural format Enforcement Priorities in Healthcare in 2018: to discuss HCQIA, medical staff bylaws, what A Discussion constitutes an adverse recommendation, hearing What a valuable event – MS. FULLMER, MS. LEAHY, MS. MALONE, MR. RAPHAEL notice contents, the importance of re-hearing “ conferences, the role of the Hearing Officer, We will discuss criminal and civil enforcement discovery considerations, strategic use of expert well worth the cost!” priorities in health care for 2018 and beyond. witnesses, settlement negotiations, and appellate Topics include: • changes in criminal enforcement review standards. priorities for the Medicaid Fraud Unit of the Attorney General’s Office of Commonwealth of Pennsylvania 19. Blockchain and Healthcare Privacy Laws Just in 2018 and beyond • the Attorney General’s use of Don’t Mix civil statutes to pursue providers • an update on MR. GUAGLIARDO, MS. KLEIN federal criminal and civil enforcement priorities MAR under the Trump Administration. Many experts believe blockchain technology will Wednesday drive innovation in health information and that 28. Successful Integration and Use of Advanced it has the potential to solve critical health care 14 Practice Professionals (APPs) issues, including interoperability, security, records MS. NAGELE, MS. SHER management and data exchange. But will the heavily regulated health care industry be able The use of APPs in the hospital and ambulatory am am to adopt the technology in a meaningful way? 8:30 – 9:30 setting is expanding rapidly, driven by quality, Learn how blockchain technology works, as well efficiency and economic factors. We will address a as potential applications in health care, including PLENARY SESSION host of challenges: • licensing and clinical oversight regulatory barriers to implementation and privacy of APPs • credentialing and privileging challenges 23. News from Washington: What’s Happening concerns. • establishing scope of practice • engaging the at HHS supervising/collaborating physicians in effective JUST THE BASICS (2:25 – 2:55 pm) CURRENT DEPUTY SECRETARY HARGAN oversight of APPs • integrating APPs into medical Hear directly from the Deputy Secretary of Health staff governance. 20. Basics of Medicare/Medicaid Fraud & Abuse and Human Services about what is happening MR. SOKOLOW in Washington. You will learn about any new It is essential that health law professionals have guidelines or initiatives. Don’t miss this opportunity a grasp of the cornerstones of leading fraud and to get the “inside scoop”! abuse laws such as the Anti-Kickback Statute, the Stark Law and the False Claims Act. Here is your opportunity to explore the broad scope of these laws, recent amendments, and ongoing enforcement efforts designed to protect the public funds that support the Medicare and Medicaid programs.

7 SESSION DESCRIPTIONS

33. Living with MACRA (The Medicare Access 37. Stark Self-Disclosure Protocol— MAR and CHIP Reauthorization Act of 2015) and Do New Rules Indicate a New Attitude? Wednesday Value Based Payments in the Real World MR. CASALE MR. MATTIOLI, DR. MOSES, MR. SHERRY continued 14 Beginning on June 1, 2017, providers must use The move towards value based payment models CMS’s updated Stark Self-Disclosure. Attend to will continue to create disruption throughout the hear: • an overview of the new protocol • what has medical community, and especially in the physician changed • what has remained the same am pm 11:00 – 12:00 community. Explore the underlying issues that • how the new rules and policy statements that these models may create in terms of practical day were published in the November 15, 2015 Federal 29. Community Health Choices and the New to day operations, as well as the potential legal Register are affecting this process. Federal Medicaid Managed Care Rules issues that may be generated as a result of these MR. CHERRY, MR. HANCOCK, MS. LEISCH new developments. 38. Community Health Choices: Using Managed Care to Deliver Medicaid-Funded Long-Term Community Health Choices (CHC) is Pennsylvania’s Services and Supports (LTSS) in Pennsylvania new managed care program for health care and 1:15 pm – 2:15 pm MR. MILLER-WILSON, MS. TORREGROSSA long-term services and supports rendered to older persons and persons with physical disabilities. We The state has begun its ambitious initiative to 34. Hot Issues in Health Insurance from the will address the new federal Medicaid managed put more than 420,000 Pennsylvanians who are Insurance Regulator Perspective care regulations issued in 2016; DHS’s experience dually eligible for Medicare and Medicaid and MR. MENDELSOHN, MS. YKEMA navigating those requirements; and the unique individuals with physical disabilities into Medicaid components of CHC, including the complaints and Come to hear about the hot topics in health managed care. Examine how the program has rolled grievances process. insurance from the perspective of the state out in Southwestern PA, plans for the roll out in regulator, including: • the alphabet soup in the Southeastern PA starting in July 2018 and what it SUPER WORKSHOP news, AHPs, STLDIs, HRAs, HSAs, CSRs, §1332 and has meant for providers and consumers. more • MHPAEA—mental health parity requirements 30. Lessons Learned from Physician Leasing and enforcement • inter-agency efforts to address 39. Beyond the Financial Terms: Understanding MS. GOSFIELD the opioid crisis • national litigation update Key Legal Issues in Payer-Provider Contracts Attend to discover: • issues in the Professional • state legislation update. in 2018 Services Agreement • whether there is a separate MR. RAPHAELY Management Services Agreement • whether Attend to become aware of the key non-financial restrictive covenants are necessary • how to handle terms of payer-provider contracts. Topics include: the introduction of new physicians • dispute • limited networks • audits and data requests resolution • fair market value issues • clinical “This Institute has an excellent mix • assignment • tiered networks • takebacks and integration • who owns the records • how is the offsets • after-acquired providers • utilization second negotiation different. of pertinent topics affecting review • regulatory requirements • eligibility determinations • all products clauses • leases 31. What’s the Future of the CMS 60-Day and rental network • dispute resolution • issues Overpayment Rule — Can Negligence Really the healthcare industry. ” presented by self-insured plans • value based Trigger False Claims Act Exposure? programs • contract amendments. MS. HEIN, MS. ROWLAND Join us for a discussion on: • the 60-Day Rule 2:25 pm – 3:25 pm application to Medicaid and Medicare • the 35. Smashing into Windows: The Limits of must-watch, ongoing federal litigation brought Consumer Sovereignty in Health Care by United Healthcare Insurance Company’s Part C PROF. FURROW 40. PA Department of Health Update plans against the United States to square agency MR. KOLTASH, MS. LESHKO, MR. SNYDER “Transparency” in health care imagines model rulemaking imposing a negligence standard for patients who can manage their own illness, process Join us to explore the issues that were addressed by addressing overpayments on Medicare Part C and all information, and partner with the doctor. the Pennsylvania Department of Health during the D providers with the FCA’s stricter “knowledge” Consider the structural, legal, and behavioral past year and that are expected to remain of prime requirement • steps that providers can take to barriers to such an ideal model of patient choice, importance in 2018. Learn about implementation mitigate against potential fraud liability in this including physician constraints, hospitals’ lack of of any recently enacted legislation and any uncertain regulatory landscape. responsibility, and patient bounded rationality. forthcoming promulgation of new and revised Examine the evolution of consent models. Explore regulations. 32. The Opioid Epidemic in Pennsylvania: structural changes such as patient engagement Top 10 Legal Considerations for Health Care in accountable care organizations (ACOs), and SUPER WORKSHOP ETHICS Providers technologies such as virtual tools and social media MR. MOAK to improve patient decision-making. 41. Advice for Lawyers Considering Explore the top ten legal issues presented by “Reporting Up” Information about Illegal the opioid epidemic in Pennsylvania, including ETHICS Conduct “To the Highest Authority” the evolving regulatory landscape, clinical MR. SHEEHAN 36. Being Professionally Responsible in a collaboration among providers, managed care and Sometimes Irresponsible Healthcare World How should lawyers act when they believe that reimbursement issues, obligations with respect MS. BENESCH, MR. WAX corporate agents engage in actions or refuse to the criminal justice and child welfare systems, to engage in actions which violate the legal In a complicated, and ever-changing legal litigation, and future changes on the horizon. obligations of the organization? What factors environment, healthcare lawyers often walk a fine should they consider? What record should line in determining what is legal, what is ethical, they develop? Examine the ethical duties and and what is not. We will address: • who is the client options for attorneys with knowledge of actual or in various hospital/physician situations • conflicts potential illegal conduct by the organization or of interest in healthcare corporate and litigation its agents. Analyze the differing rules that apply in settings • the role of counsel versus business advisor Pennsylvania and New Jersey to the same conduct, • confidentiality and sharing information with and additional obligations imposed by Sarbanes- third parties • the role of indemnity in healthcare Oxley. documents.

8 42. Regulatory Implications of Various Hospital 3:35 pm – 4:35 pm 47. The Regulation of Medical Marijuana Under Service Configurations — An Update Federal and Pennsylvania Law on Provider-Based Status, Co-Location MR. GOLDBERG 45. New LLC Law in PA: How Is It Changing the Arrangements and Micro Hospitals Structure of Healthcare Entities For thousands of years marijuana has been MS. LAMANNA, MS. RALEIGH MR. HOY, MS. JACOBS believed to provide health benefits. In 1970, it Explore with us: • provider-based status – was officially outlawed as a Schedule 1 drug Learn the changes to LLC law in Pennsylvania, mid-build attestations, shared space considerations under the Controlled Substances Act. Over time resulting from the enactment of Act 170, effective and provider-based audits • regulatory issues with a number of states passed legislation permitting April 1, 2017: • structure and context of the new co-located providers and suppliers, including the cultivation, processing, dispensing and LLC law • governance of LLCs • duties of members hospitals within hospitals and satellites • micro consumption of marijuana for medical and/or and managers • nature and transferability of hospitals – what are they and can they survive recreational purposes, including Pennsylvania. membership interests. regulatory scrutiny? The story on marijuana is expansive and evolving. This session focuses on the current and historical 43. Tax Issues Impacting Tax-Exempt Healthcare federal framework for cultivating, selling and using Organizations marijuana in the U.S., and Pennsylvania’s medical MR. HENNESSEY “This is the best place to get marijuana legislation. Take away an update on various tax issues 48. Clinical Laboratories: specifically affecting tax-exempt Section 501(c)(3) CLE credits and learn about the They’re Back Under the Government healthcare organizations. Topics include: • impact and Whistleblower’s Microscope of ACA repeal/replacement and federal tax reform latest in healthcare law!” MS. BRECHT legislation • recent federal income tax cases, rulings and other developments • status of Section Join us for a discussion on: • clinical laboratory 501(r) compliance/audits • IRS Form 990 and other cases which have been settled or are being litigated procedural updates • Pennsylvania state/local tax throughout the United States • fraud theories that issues. 46. Telemedicine Implementation: are new or back after many years • the prosecution Do’s and Don’ts and qui tam relators’ theories, as well as some of 44. One Call Away: Healthcare Telephone MR. QUASHIE, MS. ROSENTHAL the defenses that are being raised • the interesting Consumer Protection Act (TCPA) Class defense and government motion practices that are Cross-border licensure, reimbursement, scope Actions occurring in some of these laboratory cases. of practice, credentialing, vendor selection, MR. ROSENTHAL contracting, cybersecurity, and liability are some of 49. Advancing Value-Based Contracting for In the healthcare context, the Telephone the issues organizations need to properly address to Prescription Drugs and Medical Devices Consumer Protection Act (TCPA) law regulates establish a compliant and functioning telemedicine MR. BASSMAN, MR. BOISE the use of automatic telephone-dialing systems program. Join us to learn the best practices to to contact patients for debt collection purposes, observe when implementing a proper telemedicine Rising health care and prescription drug prices as well as healthcare related text reminders and program, as well as common missteps that may have dominated the headlines for months, as confirmations (like flu shots and appointment potentially reduce the chance of success. lawmakers and companies search for solutions that reminders, lab results, and prescription lower costs while preserving quality of care. Payors, notifications). Take away helpful insights to government and industry have endorsed using minimize the risk of, and defend against, a TCPA value-based contracting for prescription drugs and class action. devices, but significant regulatory hurdles still exist. Using a case study, examine issues in value-based contracting, including contractual considerations.

THANKS TO OUR DEDICATED INSTITUTE PLANNING TEAM

Andrea M. Kahn-Kothmann, Esq. Mark L. Mattioli, Esq. Edward F. Shay, Esq. Ruth M. Siegel, Esq. THOMAS JEFFERSON UNIVERSITY GREENBERG TRAURIG, LLP, PHILADELPHIA PHILADELPHIA HERSHEY PHILADELPHIA Mr. Mattioli concentrates his health law Mr. Shay retired from the practice of law. Ms. Siegel practices exclusively in the Ms. Kahn-Kothmann is Senior Counsel practice in the areas of antitrust, privacy, He practiced in the health care field with field of health law. Her practice includes at Thomas Jefferson University in fraud and abuse, credentialing, HITECH/ special emphasis on complex regulatory representation of institutional and Philadelphia, where she has been a HIPAA and commercial litigation involving problems and provider relationships individual health care providers in member of the legal team for 11 years. healthcare providers. His practice with payors. Much of his practice focused business and regulatory matters. In addition to representing the health includes representation of, among on the critical intersection between sciences university and its component others, clients in antitrust litigation, class e-health, electronic health information professional schools on general action litigation, fraud, false claims act, management and such rapidly evolving legal matters, her primary clients are breach of contract and negligence claims payor relationships as consumer directed Jefferson’s various health care provider where he has dealt with the discovery health arrangements, performance based entities, including a 650-physician, of electronic evidence in a variety of compensation and data driven care multi-specialty faculty practice plan and different contexts. solutions. several acute care hospitals which she represents on health care regulatory and transactional issues.

9 OUR OUTSTANDING FACULTY

Charles I. Artz, Esq. Kevin E. Hancock Jessica C. LaManna, Esq. Jeffrey N. Rosenthal, Esq. ARTZ MCCARRIE HEALTH LAW CHIEF OF STAFF, PA DEPARTMENT OF SENIOR COUNSEL, UNIVERSAL HEALTH BLANK ROME LLP, PHILADELPHIA HARRISBURG HUMAN SERVICES, HARRISBURG SERVICES, KING OF PRUSSIA Kaitlin M. Rosenthal, Esq. Barak A. Bassman, Esq. Eric D. Hargan, Esq. M. Beth Leahy, Esq. ASSISTANT GENERAL COUNSEL, THOMAS LLP, PHILADELPHIA DEPUTY SECRETARY, U.S. DEPARTMENT U.S. ATTORNEY’S OFFICE FOR THE JEFFERSON UNIVERSITY HOSPITAL OF HEALTH AND HUMAN SERVICES EASTERN DISTRICT OF PA, PHILADELPHIA PHILADELPHIA Katherine Benesch, Esq. WASHINGTON, DC BENESCH & ASSOCIATES, LLP Edward I. Leeds, Esq. Barbara Rowland, Esq. PRINCETON, NJ John M. Harris, MBA LLP, PHILADELPHIA POST & SCHELL, P.C., WASHINGTON, DC VERALON PARTNERS INC., PHILADELPHIA Barbara A. Blackmond, Esq. Doris M. Leisch, Esq. Daniel F. Ryan, III, Esq. HORTY, SPRINGER & MATTERN, P.C. Elizabeth M. Hein, Esq. CHIEF COUNSEL, PA DEPARTMENT O'BRIEN & RYAN, LLP PITTSBURGH POST & SCHELL, P.C., PHILADELPHIA OF HUMAN SERVICES, PHILADELPHIA PLYMOUTH MEETING

Barry H. Boise, Esq. Daniel J. Hennessey, Esq. Tanya C. Leshko, Esq. Stephanie Winer Schreiber, Esq. PEPPER HAMILTON LLP, PHILADELPHIA STEVENS & LEE, KING OF PRUSSIA SENIOR COUNSEL, PA DEPARTMENT BUCHANAN INGERSOLL & ROONEY PC OF HEALTH, HARRISBURG PITTSBURGH Caroline B. Brancatella, Esq. Pamela E. Hepp, Esq. GREENBERG TRAURIG, LLP, ALBANY, NY BUCHANAN INGERSOLL & ROONEY PC Laurie A. Malone, Esq. Daniel F. Shay, Esq. PITTSBURGH CHIEF DEPUTY ATTORNEY GENERAL ALICE G. GOSFIELD & ASSOCIATES, P.C. Pamela Coyle Brecht, Esq. PA OFFICE OF ATTORNEY GENERAL PHILADELPHIA HARRISBURG PIETRAGALLO GORDON ALFANO BOSICK & David R. Hoffman, FCPP, Esq. RASPANTI, LLP, PHILADELPHIA DAVID HOFFMAN & ASSOCIATES, P.C. James G. Sheehan, Esq. PHILADELPHIA Seth A. Mendelsohn, Esq. CHIEF OF THE CHARITIES BUREAU Joseph A. Bubba, Esq. EXECUTIVE DEPUTY INSURANCE NY OFFICE OF THE ATTORNEY GENERAL Matthew J.D. Hogan, Esq. COMMISSIONER, PA INSURANCE NEW YORK, NY FITZPATRICK LENTZ & BUBBA DEPARTMENT, HARRISBURG CENTER VALLEY MORGAN, LEWIS & BOCKIUS LLP PHILADELPHIA Stephanie C. Sher, Esq. Henry M. Casale, Esq. THE JOHN HOPKINS HEALTH SYSTEM BALTIMORE, MD HORTY, SPRINGER & MATTERN, P.C. PITTSBURGH The willingness of our top flight faculty to share experiences, Daniel J. Sherry, Esq. Edward G. Cherry, Esq. practice tips and new ideas is one of the reasons the MARSHALL DENNEHEY WARNER COLEMAN & GOGGIN, P.C., KING OF PRUSSIA DEPUTY CHIEF COUNSEL, PA DEPARTMENT Health Law Institute is so popular year after year. OF HUMAN SERVICES, HARRISBURG Maraleen D. Shields, Esq. Gregory M. Fliszar, J.D., Ph.D. FITZPATRICK LENTZ & BUBBA CENTER VALLEY COZEN O'CONNOR, PHILADELPHIA Barbara J. Holland, Esq. Laval S. Miller-Wilson, Esq. REGIONAL MANAGER, U.S. DEPARTMENT EXECUTIVE DIRECTOR, PENNSYLVANIA Karen Smith Charlene Keller Fullmer, Esq. OF HEALTH AND HUMAN SERVICES HEALTH LAW PROJECT, PHILADELPHIA PHILADELPHIA ASSISTANT COMPLIANCE OFFICER U.S. ATTORNEY'S OFFICE FOR THE MAIN LINE HEALTH, RADNOR EASTERN DISTRICT OF PA, PHILADELPHIA Douglas L. Moak, Esq. Charles M. Honart, Esq. INDEPENDENCE BLUE CROSS Douglas A. Snyder, Esq. Professor Barry R. Furrow STEVENS & LEE, KING OF PRUSSIA PHILADELPHIA SENIOR COUNSEL, PA DEPARTMENT DREXEL UNIVERSITY THOMAS R. KLINE OF HEALTH, HARRISBURG SCHOOL OF LAW, PHILADELPHIA Timothy A. Hoy, Esq. Richard E. Moses, D.O., J.D. METTE, EVANS & WOODSIDE, HARRISBURG PHILADELPHIA David S. Sokolow, Esq. Mark H. Gallant, Esq. FOX ROTHSCHILD LLP, PHILADELPHIA COZEN O’CONNOR, PHILADELPHIA Margaret L. Hutchinson, Esq. F. Lisa Murtha, JD CHIEF OF THE CIVIL DIVISION ANKURA CONSULTING GROUP, LLC Karl A. Thallner, Jr., Esq. Alisa M. Gifford, Esq. U.S. ATTORNEY'S OFFICE FOR THE PHILADELPHIA REED SMITH LLP, PHILADELPHIA CIGNA, PHILADELPHIA EASTERN DISTRICT OF PA, PHILADELPHIA Michael M. Mustokoff, Esq. Ann G. Torregrossa, Esq. Seth A. Goldberg, Esq. Lisa R. Jacobs, Esq. LLP, PHILADELPHIA SWARTHMORE DUANE MORRIS LLP, PHILADELPHIA DLA PIPER, PHILADELPHIA Robin Locke Nagele, Esq. Prof. R. Lawrence Van Horn Alice G. Gosfield, Esq. Victoria Heller Johnson, Esq. POST & SCHELL, P.C., PHILADELPHIA VANDERBILT UNIVERSITY, NASHVILLE, TN ALICE G. GOSFIELD & ASSOCIATES, P.C. FOX ROTHSCHILD LLP, EXTON PHILADELPHIA Karen L. Palestini, Esq. Sharon R. Klein, Esq. DILWORTH PAXSON LLP, PHILADELPHIA Robert L. Wax, Esq. Kathleen A. Grogan, Esq. PEPPER HAMILTON LLP, PHILADELPHIA ST LUKE’S UNIVERSITY HEALTH NETWORK BETHLEHEM DEPUTY CHIEF COUNSEL, PA DEPARTMENT René Y. Quashie, Esq. OF HUMAN SERVICES, HARRISBURG Jonathan D. Koltash, Esq. COZEN O'CONNOR, WASHINGTON, DC SENIOR COUNSEL, PA DEPARTMENT OF Sandra L. Ykema, Esq. Joseph C. Guagliardo, Esq. HEALTH, HARRISBURG PA INSURANCE DEPARTMENT Kirsten McAuliffe Raleigh, Esq. HARRISBURG PEPPER HAMILTON LLP, PHILADELPHIA STEVENS & LEE, KING OF PRUSSIA Doreen D. Kornrumpf, Esq. Linda E. Haddad, Esq. THOMAS JEFFERSON UNIVERSITY Kevin E. Raphael, Esq. PHILADELPHIA HORTY, SPRINGER & MATTERN, P.C. PIETRAGALLO GORDON ALFANO BOSICK PITTSBURGH & RASPANTI, LLP, PHILADELPHIA David M. Laigaie, Esq. ECKERT SEAMANS CHERIN & MELLOTT R. Christopher Raphaely, Esq. LLC, PHILADELPHIA COZEN O'CONNOR, PHILADELPHIA

10 10023clw/eb-11/15/2017

24TH ANNUAL MAIL PBI 5080 Ritter Rd. HE ALTH L AW INSTITUTE Mechanicsburg, PA 17055-6903 Pennsylvania Convention Center, 12 & Arch Sts. | 8:30 am - 4:35 pm both days; check-in at 7:45 am

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r $200 Attorneys licensed 5 years or less, r $325 Attorneys licensed 5 years or less, judicial judicial law clerks & paralegals law clerks & paralegals CLE Credits: Each day of this Institute has been approved by the Pennsylvania Continuing Legal Education Board for 6 hours of CLE credit. Workshop FEES INCREASE $50 AFTER FEB. 20, 2018 FEES INCREASE $75 AFTER FEB. 20, 2018 choices will determine whether credits are in substantive law, practice and procedure or ethics, professionalism or substance abuse. ██ DIGITAL DOWNLOAD OF COURSE MATERIALS— INCLUDED IN YOUR REGISTRATION CPA Credits: The Pennsylvania Bar Institute has been accepted as a program sponsor by the PA State Board of Accountancy and the State of New Jersey Board of One copy of the always popular materials from the 24th Annual Health Law Institute © 2018 PBI Accountancy. Each day of this program qualifies for a is included for the day(s) of your registration. You will receive a link to the downloadable materials prior total of 7 hours of continuing education credit. to the Institute. PENDING Risk manager Credit: Approval is pending for Risk Manager credit for this program from ASHRM. You can purchase the printed versions for just an additional $50.

PENDING Nursing Home Administrator Credit: r I am attending and would like to purchase the printed materials. Approval is pending for Nursing Home Administrator credit for this program. If you’re a nursing home COURSE BOOK in addition to DIGITAL DOWNLOAD (2017 - 9611) $50 administrator, the Institute will offer an ideal way for you to meet, discuss and consider so many of the I cannot attend, but I would like to purchase the: legal issues with which you deal day in and day out. r COURSE BOOK (2018-10023): $149—Include $8.00 shipping and handling and $9.42 sales tax Registration Policy: Pre-registered customers will receive priority on the distribution of course for a total of $166.42 materials. Walk-in registrations will be accepted on a r DIGITAL DOWNLOAD (DL-10023): $149—Include $8.94 tax for a total of $157.94 space-available basis. Please check www.pbi.org or call (800) 247-4724 to confirm space is available and the schedule has not changed. If you are ordering printed course materials separately, please allow two weeks after the course for the Registration Transfers: Requests for transfers will be shipment of books. A 10-day return privilege applies to all book orders, less a handling & restocking fee of honored if they are received before the course date. $8.00. The return privilege does not apply to electronic downloads.

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PBI Scholarships: PBI offers substantially reduced Phone ( ) - Fax ( ) - tuition for most PBI seminars to allow attorneys experiencing financial hardship to fulfill their I have enclosed my discount coupon in the amount of $ for my ☐ 1st ☐ 2nd ☐ 3rd ☐ 4th ☐ 5th seminar mandatory education requirement. For details and an application, contact Scholarship Administrator at [email protected] or (800) 932-4637, ext. 2284 at A check made payable to PBI for $ is enclosed least 30 days before the program. (Scholarships are not available for Online CLE.) Charge my: ☐ American Express ☐ MasterCard ☐ Visa ☐ Discover Legal Services/Public Interest Lawyers: PBI will provide a complete waiver of tuition fees for the first Card # 12 hours of CLE taken to satisfy the Pennsylvania mandatory CLE requirement in any calendar year for all attorneys employed on a full-time basis Signature by Pennsylvania civil or criminal Section 501(c) (3) legal services or public interest organizations. For additional courses (over and above the first 12 hours), eligible attorneys may enroll at 50 percent of the highest member fee. This waiver applies only to attorneys in Section 501(c)(3) organizations that provide legal services at no or de minimus fee to .org individual members of the public. 11 THANK YOU FOR VOTING PBI THE BEST OF 2017 At PBI, we are focused on bringing you the best in Pennsylvania-specific CLE and maintaining the gold standard of quality we have set and strived for.

24TH ANNUAL HE ALTH L AW INSTITUTE

SPECIAL THANKS TO OUR SPONSORS

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Thanks to our cosponsors

PBA Health Care Law Committee Pennsylvania University of Pittsburgh Health Care Association School of Law The Healthcare Law Committee of the Business Law Section of the Philadelphia LeadingAge PA Thomas R. Kline School Bar Association of Law at Drexel University Pennsylvania Association of County Aff iliated Homes Widener University School of Law