8:55 Welcome and Introductions
9:00 Health Care Innovations and Their Impacts
Robert Saunders Ph.D, Duke University Margolis Center for Health Policy, Durham
Listen as an expert in health care policy taps into his experience — as a former senior director of health care policy at the White House, former administrator for CMS, former commissioner of the FDA, and a leading authority on our nation's COVID-19 response — to address recent innovations and their impact on the future of the health care industry.
9:34 The Telemedicine Explosion: Policy Considerations and Practical Realities
Gina L. Bertolini, K&L Gates LLP, Research Triangle Park
Marcus B. Jimison, North Carolina Medical Board, Raleigh
John H. Lawrence, K&L Gates LLP, Research Triangle Park
Leah D'Aurora Richardson, K&L Gates LLP, Research Triangle Park
Receive an outline of telemedicine in North Carolina and survey state law changes nationwide. Explore current telemedicine models, corporate practice of medicine considerations, federal waivers and exceptions, pending legislation affecting the expansion and reimbursement of telemedicine, and government enforcement trends. Then examine Medical Board and other policy considerations, pending legislation affecting the expansion and reimbursement of telemedicine, government enforcement trends, and practical realities of long-term expanded telemedicine.
11:06 Break
11:16 HR Gone WILD: Shots, Shouts, Shortages and More
Patricia Kelly, Novant Health, Charlotte
Alexander Lyon "Alex" Maultsby, Ramseur Maultsby LLP, Greensboro
Patti West Ramseur, Ramseur Maultsby LLP, Greensboro
This panel discussion brings together an in-house lawyer from a large health system with private practitioners to analyze the pandemic's impact on employment law, including mandatory vaccinations, exemption requests, employee shortages and burnout, and how shifting state and federal regulations have created a new landscape.
12:47 Lunch Break
1:17 Privacy and Data Compliance Challenges From All Angles: Practical Tips to Manage Risk‡
Tara N. Cho, Womble Bond Dickinson (US) LLP, Raleigh
From the HIPAA proposed rulemaking and Office for Civil Rights' continued right of access enforcement, to the FTC's renewed focus on healthcare app developers, Office of the National Coordinator for Health Information and Technology's information blocking rules, and countless ransomware attacks, the health care industry is faced with compliance challenges across all aspects of operations. The rapid expansion of telehealth services throughout the pandemic and continued innovation across the health-tech sector provide essential benefits to patients and consumers but also add to the complexities of data privacy and cybersecurity risk. This session addresses practical ways to manage risk without stifling creative advancements in health care models.
2:17 How to Be a Peace-Filled Attorney†
William M. "Bill" Satterwhite, Herrin Health Law PC, Atlanta, GA
Listen, learn and laugh as an attorney-physician walks through the effects of stress on the human body and the influences of our diet, as well as concrete actions we each can take to decrease our personal stress.
3:18 Adjourn
† Indicates portion providing Substance Abuse/Mental Health credit
‡ Indicates portion providing Technology Training credit
Thank you for joining us for Change Can Happen Fast — Bring an Umbrella (2022 Health Law Section Program).
It is no secret that health care is evolving at a rapid pace. Driven by necessity to keep up with a world forever changed by the pandemic — increasingly driven by technology and remote interaction — providers, payors and other stakeholders must continue to innovate how health care is delivered.
Gina L. Bertolini is a partner with K&L Gates LLP in Research Triangle Park. She concentrates her practice exclusively on health law; primarily representing academic medical centers, health systems, community hospitals, physician practices, and ancillary providers. As a result of this diversified practice, her proficiency extends to federal and state regulatory compliance matters, Medicare and Medicaid reimbursement, faculty practice plan and other physician compensation models, health care fraud and abuse, the Emergency Medical Treatment and Labor Act (EMTALA), health care privacy and data protection issues including HIPAA and 42 CFR Part 2, health care group purchasing organizations (GPOs), and health care corporate governance matters. She likewise maintains an active transactional practice, representing health systems, physician practices, and ancillary providers in acquisitions and joint ventures.
Gina is an active author and speaker on critical issues affecting the health care industry.
Gina earned her B.F.A., with honors, from DePaul University and her J.D. from the University of California Hastings College of Law.
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Tara N. Cho chairs Womble Bond Dickinson (US) LLP's Privacy and Cybersecurity Team in Raleigh. Her practice is dedicated to counseling clients on privacy and data security issues across industries such as technology, retail, e-commerce, healthcare, health-tech, and life sciences. She advises clients on matters related to the CCPA, CPRA and other state privacy laws, HIPAA, Gramm-Leach-Bliley Act, TCPA, CAN-SPAM, and other state and federal privacy, cybersecurity and data breach laws in the U.S. She also advises clients on the GDPR (and UK GDPR) and related requirements of European data protection laws.
Tara helps companies establish and assess compliance programs, respond to data breaches and security incidents, conduct risk analyses, negotiate contracts that govern data use and security, respond to regulator requests and investigations, and address new and evolving issues stemming from the development of mobile and web-based applications, cloud computing, machine learning and AI tools, IoT devices, and other technology solutions that rely on personal data.
Tara became certified as a legal specialist in Privacy and Information Security Law by the North Carolina State Bar Board of Legal Specialization in 2018 as part of the inaugural class of specialists in this field. She is also recognized by the IAPP as a certified information privacy professional for the US (CIPP/US) and Europe (CIPP/E).
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Sarah B. Crotts is of Special Counsel with Parker Poe Adams & Bernstein LLP in Charlotte. She has more than a decade of experience advising hospitals, physician groups, insurers, life sciences companies, and a range of health care providers. She has particularly extensive knowledge of health care compliance issues. She has helped clients navigate federal and state regulations regarding the Stark Law, Anti-Kickback Statute, anti-markup rule, account billing laws, corporate practice of medicine, Medicare reimbursement, Physician Payments Sunshine Act, certificate of need requirements, HIPAA, and the HITECH Act. She has also counseled clients on responding to government and insurance company audit requests.
In addition, Sarah has reviewed, revised, and drafted managed care agreements for both providers and insurance companies. She has also prepared and reviewed a variety of physician recruitment, employment, vendor, business associate, professional services, and lease agreements.
Sarah is certified by the North Carolina Dispute Resolution Commission (NCDRC) as a Superior Court mediator. She began her health law career as an attorney with Womble Bond Dickinson (US) LLP and then moved to Wall Babcock LLP.
Sarah is deeply invested in community service. She is a leader within the North Carolina Bar Association's Health Law Section, serving as its vice chair, past secretary, past treasurer, and Continuing Legal Education (CLE) Committee co-chair. She is currently secretary of the board of the YWCA of Winston-Salem and a member of the board of the Washington and Lee University Winston-Salem Alumni Chapter.
Sarah received her B.A. degree, cum laude, from Washington and Lee University in 2002 and her J.D. degree from Wake Forest University School of Law in 2005.
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John W. Gibson is an associate at Smith Anderson Blount Dorsett Mitchell & Jernigan LLP in Raleigh. He is a member of the firm's Health Care group. He focuses his practice on advising a variety of health care stakeholders, including large physician group practices, clinically integrated networks, accountable care organizations, laboratories, long term care providers and investors focused on the health care industry. His experience includes helping clients navigate the complex federal and state regulatory environment surrounding the health care industry, including compliance under HIPAA, HITECH, Stark Law, the Anti-Kickback Statute and the False Claims Act. He also provides strategic counsel related to value-based care programs and accountable care issues generally.
John also advises clients on commercial transactions and corporate matters, including mergers and acquisitions, governance issues, contract negotiation, business formation and compliance with licensing rules and regulations.
John earned his B.A. from Clemson University, his M.H.A. from University of South Carolina Arnold School of Public Health and his J.D. from University of South Carolina School of Law.
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Marcus B. Jimison is the Senior Board Attorney at the North Carolina Medical Board in Raleigh. He represents the Board in disciplinary cases involving physicians, physician assistants and other licensees. He advises the board on issues related to the corporate practice of medicine and advanced practice and allied health providers. Marcus is the primary medical board attorney assigned to the board's Advanced Practice Providers and Allied Health Committee, Nurse Practitioner Joint Subcommittee and Joint Subcommittee Panel, Joint Midwifery Committee, and the Perfusionists Advisory Committee.
Previously, Marcus was the staff attorney for the North Carolina Prisoner Legal Services from 1993 to 1998 and the managing attorney for the Land Loss Prevention Project from 1998 to 2002.
Marcus received his B.A. in History and Economics from UNC-Chapel Hill and his J.D., cum laude, from North Carolina Central University. He has been a member of the North Carolina Bar Association Health Law Section since 2002 and was a Health Law council member from 2008 to 2011.
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Patricia Kelly is Director and Associate General Counsel at Novant Health in Charlotte. She's worked at Novant Health for since 2017 and assists with employment-related matters, compliance issues, sponsorships, athletic-related contracts, and other transactional work.
Patricia earned her B.A. in Marketing from University of Notre Dame and her J.D. from University of Notre Dame Law School.
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John H. Lawrence is a partner at K&L Gates LLP in Research Triangle Park. He primarily counsels healthcare clients in responding to governmental investigations and defending False Claims Act lawsuits. He frequently represents hospitals, hospital systems, academic medical centers, health care corporations, laboratories, pharmaceutical companies, durable medical equipment companies, and individuals in health care fraud investigations involving the U.S. Department of Justice, U.S. Attorneys' Offices, and other federal and state agencies. His background also includes significant experience handling complex civil litigation inside and outside of health care.
In addition to his litigation practice, John advises clients on health care regulatory matters, including those involving the Stark Law and Anti-Kickback Statute.
Prior to joining the firm, John was an associate at law firms in Nashville and Chattanooga, Tennessee where he concentrated his practice on health care fraud and abuse, compliance and government investigations, and commercial litigation.
John earned his B.A. from Duke University, his M.Div. from Wake Forest University and his J.D. from University of North Carolina at Chapel Hill School of Law.
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Ted Lotchin is Vice President, Chief Compliance & Privacy Officer with WakeMed Health & Hospitals, a 1,200-bed health system located in Raleigh. In that role, he is responsible for the development, implementation, and oversight of WakeMed's comprehensive corporate integrity and compliance program.
Prior to joining WakeMed, Ted was a partner in the health law group of an international law firm. He counseled a broad range of clients, including hospitals and academic medical centers, physician practices, ambulatory service providers, and pharmaceutical and medical device companies, on regulatory, reimbursement, and transactional matters, as well as on False Claims Act litigation. He has extensive experience representing health care companies on compliance with the Stark Law, the Anti-Kickback Statute, and other relevant Medicare and Medicaid fraud and abuse issues. He has defended numerous qui tam cases, and handled internal investigations, self-disclosures, overpayments and other enforcement matters.
Ted previously served as in-house counsel to a major academic medical center, where he advised deans, department chairs, and other senior executives on transactional and compliance matters related to network development strategies, patient centered medical homes, and accountable care organizations, as well as on clinical outreach, data privacy and security issues, and data breach response investigations.
Ted is a member of the Health Law and Privacy & Data Security Sections of the North Carolina Bar Association. He is also a member of the Health Care Compliance Association, American Health Lawyers Association and the National Association of College and University Attorneys.
Ted earned his B.S. in Psychology and History from the University of North Carolina at Chapel Hill, his M.P.H. in Health Sciences from Boston University and his J.D. from the College of William and Mary – Marshall Wythe Law School.
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Alexander Lyon "Alex" Maultsby is a labor and employment attorney with Ramseur Maultsby LLP in Greensboro. For twenty-five years, he has focused his practice on employment law—because he enjoy the human element, using the law to find solutions for clients that face people-problems in the workplace.
This focus means talking to clients on the phone or in person, helping them achieve objectives within the many laws that operate at the state and federal levels. His own experience is quite broad and varied, across many industries and many issues, whether in litigation or in a counseling and advising role. He works to keep their corporate clients in compliance and to defend them when they are sued – or sue on their behalf, such as when non-compete and trade secret issues are at stake.
Of course, this overall role requires knowledge of Title VII, Title IX, the Equal Pay Act, the ADEA, the details and interactions of the ADA and FMLA and workers compensation, the FLSA, non-compete, and trade secret laws, contract law, many state laws, and more. Sometimes clients need a good listener, a patient advisor, and a practical thinker. At other times, clients need an aggressive and dedicated advocate who understands the ins and outs of litigation.
Alex earned his B.A., cum laude, from Davidson College and his J.D., with honors, from University of North Carolina School of Law.
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Antonia A. "Toni" Peck is a partner in the Womble Bond Dickinson (US) LLP's Research Triangle Park office and a member of the firm's Healthcare Team. Her practice is focused on assisting healthcare providers in a variety of regulatory compliance and corporate matters, including Stark law and federal and state Anti-Kickback Statute compliance, HIPAA, 340B Drug Pricing Program, physician recruitment, medical staff issues, and antitrust concerns.
Toni also counsels healthcare entities on transactional and business matters, including mergers and acquisitions, joint ventures, reorganizations, management services organizations, academic medical center affiliation agreements, and hospital-physician alignment strategies.
Toni is recognized in The Best Lawyers in America© in the field of Healthcare, as well as by Business North Carolina as a Legal Elite "Young Gun." She is active within the community, and currently serves on the Board of Directors for SouthLight Healthcare and the Goodwill Community Foundation.
Toni earned her B.A. from Duke University, her Education Certificate from University of Pennsylvania and her J.D. from Wake Forest University School of Law.
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Patti West Ramseur is an partner with Ramseur Maultsby LLP in Greensboro.
Over the last twenty-one years, Patti has focused on employment and commercial cases—for employers of all sizes, from non-profits to publicly traded companies. Her practice involves advising employers and litigating claims under Title VII, the ADA, the ADEA, the FLSA, the FMLA, and the REDA as well as claims of sexual harassment, wrongful discharge, wage and hour disputes, breach of contract, non-compete, and misappropriation of trade secrets.
Patti is the 129th President of the North Carolina Bar Association. She will also serve as President of the North Carolina Bar Foundation in 2023-24.
Patti earned her B.S., magna cum laude, from North Carolina State University and her J.D. from Wake Forest University School of Law.
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Leah D'Aurora Richardson is a partner in the K&L Gates LLP's Research Triangle Park office. She advises academic medical centers, health systems, hospitals, hospices, and ancillary service providers, such as pharmacies, and durable medical equipment suppliers and clinical laboratories, on all areas of transactional and regulatory health law.
Prior to attending law school, Leah was a medicinal chemist for almost ten years at GlaxoSmithKline and Albany Molecular Research.
Leah earned her B.S., magna cum laude, in Chemistry and B.A., magna cum laude, in Psychology from Wheeling Jesuit College, her M.S. in Physical Organic Chemistry from The Ohio State University and her J.D., University of North Carolina at Chapel Hill School of Law (Valedictorian, Highest Honors, Order of the Coif, Honors Writing Scholar, Vol. 90 Managing Editor, North Carolina Law Review).
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William M. "Bill" Satterwhite, M.D., CPE, is an Attorney at Law and Of Counsel with Herrin Health Law PC in Atlanta, GA. He brings a unique and practical perspective to the firm as both a licensed attorney and a licensed physician.
Bill spent five years practicing health care and hospital law before going to medical school. He practiced pediatrics for 15 years before moving into an executive role with a major academic medical center as its first Chief Health and Wellness Officer. During his time in this position, he used his combined knowledge and experience to develop direct care and alternative payment models for self-funded employers that saved the employers money, improved employee health, and brought significant revenues to the medical center.
Bill also is the founder of a health tech startup that has developed new patient acquisition tools. His experience is in health law, direct care models, and unique medical plans under ERISA.
Bill earned his B.A. in History at Davidson College, his J.D. from University of North Carolina School of Law and his Doctor of Medicine from Wake Forest University School of Medicine.
Bill enjoys being outdoors, reading, and public speaking. He and his wife live in Davidson where they enjoy spending time with their four children and five grandchildren.
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Robert Saunders Ph.D is Research Director, Payment and Delivery Reform at Duke-Margolis. In this role, he manages the Center's portfolio for payment and delivery reform initiatives, including bringing together faculty from across the University for developing the strategic vision in this area. He also leads specific projects in digital health technologies, evaluation of new payment policies, and federal physician payment reforms.
Prior to joining Duke-Margolis, Robert was a Senior Director and then Senior Advisor to the President of the National Quality Forum, where he managed a large federally-funded project that provided recommendations on more than 200 quality measures for 20 different federal programs in a period of two months. As Senior Advisor, he directed special projects on topics including data, payment reform, systems engineering, and future of healthcare quality measurement. There, he authored targeted communications to translate the organization’s technical work for a broad audience, including journal perspectives, white papers, and blogs and supported the development of new funding opportunities, including developing relationships with foundations and authoring concept papers and proposals. He was previously Senior Program Officer at the Institute of Medicine and managed health care legislative affairs for Representative Rush D. Holt.
Robert has previously served as an adjunct professorial lecturer at American University and the Duke University Program in Medical Physics.
Robert earned his B.S. in Physics from the College of William and Mary and completed his Ph.D. in physics and a Postdoctoral Fellowship in Medical Physics at Duke University. He served on the Duke University Board of Trustees from 2005-2007.
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David A. Senter Jr. is a shareholder at Young Moore & Henderson PA in Raleigh and focuses his practice on privacy and data security, particularly within the healthcare industry. He educates and advises clients in matters pertaining to privacy and data security, including breach investigation, notification and reporting requirements, as well as compliance with state, federal, and foreign privacy and data security laws, including HIPAA, FERPA, CCPA, GDPR, and PIPL, among others.
David previously served as the Interim Associate Compliance Officer and Director of Privacy of an Academic Medical Center in North Carolina.
David has been named to the North Carolina Lawyers Weekly 2023 Power List for Healthcare. He is also recognized in the 2024 edition of The Best Lawyers in America© in the areas of Health Care Law and Product Liability Litigation-Defendants.
David's healthcare practice includes reviewing and developing HIPAA related policies and procedures, release of information procedure manuals and authorizations, business associate agreements, and employee training materials regarding privacy and security standards. he also assists healthcare providers and other entities with privacy and data security risk assessments and incident investigations.
In addition to his privacy and data security work, David maintains an active litigation practice where he advises and represents clients in state and federal court in a number of areas including trucking and transportation, products and premises liability, and business litigation.
David holds the Certified Healthcare Privacy Compliance designation through the Healthcare Compliance Certification Board.
David earned a B.A. in History from Wake Forest University and his J.D. from Wake Forest University School of Law. While at Wake Forest, he was a member of the Moot Court Board and the Student Trial Bar Board. He was selected to represent the school as a member of both the Philip C. Jessup International Law Moot Court Team, and the National Moot Court Team.
Prior to law school, David worked in sales at CDW in Chicago, IL.
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