8:55 Welcome and Introductions
9:00 Transactions in the Health Care Industry: A View from the C-Suite
Brett J. Denton, Atrium Health, Charlotte
Jennifer Csik Hutchens, Robinson Bradshaw, Charlotte
Join the conversation with experienced corporate attorneys and in-house legal executives as they discuss unique aspects of health care transactions and provide tips for early career corporate attorneys in the health care industry.
10:02 Innovations and Hot Topics
Antonia A. Peck, Womble Bond Dickinson (US) LLP, Research Triangle Park
Robert W. Shaw, Smith Anderson Blount Dorsett Mitchell & Jernigan LLP, Raleigh
Explore how attorneys play a role in helping health care stakeholders adapt to a world turned upside down by the pandemic and shifting toward innovative care models. Then dive into a variety of developments that are revolutionizing the delivery of care and the health care sector generally, including telemedicine, population health, digital health partnerships, value-based care, employee wellness and more.
11:04 Break
11:14 Fraud and Abuse
Norman Acker, K&L Gates, Research Triangle Park
Vonne M. Jacobs, Hall Render Killian Heath & Lyman PC, Raleigh
Sean A. Timmons, Polsinelli PC, Raleigh
Discuss the federal regulatory landscape — focusing on the Stark Law, the Anti-Kickback Statute, and the False Claims Act — with experienced fraud and abuse attorneys. Discover how these laws impact health care entities in real time, explore common scenarios faced by health care attorneys, and consider the importance of compliance efforts in mitigating potential fraud and abuse risks.
12:27 Lunch Break
12:57 Privacy and Information Security‡
Allyson J. Labban, WakeMed, Raleigh
Patricia A. Markus, Nelson Mullins Riley & Scarborough LLP, Raleigh
Phishing? Ransomware? Spoofing? Electronic health records? The health care industry faces more threats to the privacy and security of sensitive information than ever. Receive a crash course in HIPAA, information blocking, relevant international authority, and other key laws and regulations designed to protect this critical data. Cover the basics of these key rules, as well as common business practices such as the use of de-identified data and reliance on third-party vendors, and discuss counseling clients to minimize risk of liability and government enforcement in this corridor.
2:01 Health Care Litigation
Melanie M. Hamilton, Ott Cone & Redpath PA, Greensboro
Elizabeth "Liz" Sims Hedrick, Fox Rothschild, Raleigh
Marcus C. Hewitt, Fox Rothschild LLP, Raleigh
Learn the ins and outs of health care-specific dispute resolution pathways from a dynamic group of litigators with many years of experience managing medical malpractice litigation, payor disputes, antitrust reviews, IP contests and administrative law proceedings.
3:04 Adjourn
‡ Indicates portion providing Technology Training credit
Thank you for joining us for Health Law Boot Camp (2022 Health Law Section Fall Program).
The Health Law Section is pleased to introduce the inaugural Health Law Boot Camp CLE, an exciting new program for early-career lawyers, lawyers looking for a refresher, and others serving the health care industry.
Norman Acker is of counsel with K&L Gates in Research Triangle Park. He brings more than three decades of experience as an Assistant United States Attorney to help guide clients facing government False Claims Act investigations or other allegations of fraud or abuse of government programs. He is a member of the Health Care and FDA practice.
Prior to joining the firm, Norman served as acting U.S. attorney, the chief federal law enforcement officer in the Eastern District of North Carolina. He previously served as an assistant U.S. attorney for more than 30 years, focusing his practice on the investigation and civil prosecution of health care fraud and other fraud against the government. In this capacity, he worked closely with the Health and Human Services Office of Inspector General (HHS-OIG), the North Carolina Medicaid Investigations Division (NC-MID), the Department of Defense Criminal Investigation Service (DCIS), the Drug Enforcement Administration (DEA), the FBI, and other law enforcement agencies. For 17 years, he served as the Deputy Chief of the Civil Division, where he both handled his own case load of civil fraud and health care fraud cases, as well as supervising all of the civil fraud, health care fraud, and False Claims Act cases for the Eastern District of North Carolina. He served briefly as the civil chief, supervising all civil litigation for the USAO, before becoming the first assistant, supervising all civil, criminal, and appellate litigation in the office.
Norman earned his B.A., Political Science, from the University of North Carolina at Chapel Hill and his J.D. from the University of North Carolina School of Law.
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Brett J. Denton is Executive Vice President & Chief Legal Officer at Atrium Health in Charlotte. He is responsible for the office of general counsel, corporate compliance, privacy, enterprise risk management, internal audit, corporate risk management and corporate insurance groups. Atrium Health, headquartered in Charlotte, is one of the most comprehensive and integrated healthcare systems in the nation with more than 70,000 teammates, 40 hospital facilities and over 1,000 care locations in North Carolina, South Carolina, Georgia, and Alabama.
Brett previously served as Senior Vice President, Regional Executive for Atrium Health, where he was responsible for the Atrium Health Regional Partnerships group and managed Atrium Health’s regional hospitals and health networks in North Carolina and South Carolina. He also previously served as Senior Vice President and Deputy General Counsel for Atrium Health. Prior to joining Atrium Health in 1999, Brett practiced law for six years with the firm Robinson Bradshaw and Hinson PA in Charlotte, where he primarily litigated business disputes.
Brett earned his B.S., Business Administration, from the University of North Carolina at Chapel Hill and his J.D. from the University of North Carolina School of Law. During law school, he served on the North Carolina Journal of International Law and Commercial Regulation. He also graduated from the North Carolina School of Science and Mathematics in Durham.
Brett is active in the Charlotte community, recently serving as Treasurer on the Arts and Science Council board of directors and previously chairing the board of directors of Crisis Assistance Ministry. He also has served on the state Health Law Council for the North Carolina Bar Association and chaired the fee dispute resolution committee of the Mecklenburg County Bar. Brett and his wife, Natalie, have three children. His oldest daughter is a trauma nurse at the University of Virginia Health System, his son is a student at UCLA, and his youngest daughter is a student at UVA.
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Lauren S. Gennett is a senior associate at King & Spalding in Asheville. Her practice focuses on the representation of healthcare clients including hospitals, healthcare companies, home health and hospice, and post-acute providers. She regularly defends healthcare organizations in government enforcement matters including investigations and False Claims Act litigation. She also advises clients on internal investigations including remediation strategies such as voluntary refunds and self-disclosures. She has significant experience counseling clients on compliance program design and effectiveness strategies, as well as obligations stemming from Corporate Integrity Agreements. She also assists clients in government audits and appeals and advises clients in various regulatory compliance and reimbursement matters.
Lauren is Certified in Healthcare Compliance (CHC), and has served as a guest lecturer at the Georgia State College of Law and the Emory Rollins School of Public Health.
Lauren earned her B.A., with highest honors, in Public Policy from the University of North Carolina at Chapel Hill, where she was elected to the Order of the Golden Fleece Honorary Society. She earned her M.P.H., with a focus in Health Policy, from the Emory University Rollins School of Public Health. She earned her J.D., with honors, from the Emory University School of Law. During law school, she was awarded the James Colson Scholarship and served as a Notes and Comments Editor for the Emory Law Journal.
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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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Melanie M. Hamilton is an attorney at Ott Cone & Redpath PA in Greensboro. She represents healthcare systems and hospitals in efforts to increase revenues. She works closely with healthcare systems in areas related to Medicaid eligibility as well as identifying other potential payment sources. She has extensive experience in administrative and court proceedings.
Melanie also focuses extensively on payment audits, billing issues, and compliance matters. She has represented hospitals and healthcare systems in connection with Medicare billing and other compliance matters before the U.S. Department of Justice. She has assisted in resolving potential civil exclusionary actions as well as negotiating and implementing corporate integrity agreement (CIAs) with the Department of Health and Human Services Office of Inspector General (OIG).
Melanie has been recognized as one of "The Best Lawyers in America" by the U.S. News & World Report and Woodward/White for Health Care Law and Litigation – Health Care and served as Chair of the Health Law Section of the North Carolina Bar Association.
Melanie earned her B.A. in Political Science and Spanish from Alma College and her J.D., cum laude, from Wake Forest University School of Law.
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Elizabeth S. "Liz" Hedrick is a partner at Fox Rothschild in Raleigh. She is a litigator who focuses primarily on real estate litigation and health care claims. She represents clients in a variety of disputes including business disputes, malpractice claims, landlord-tenant litigation and administrative law matters. She regularly represents health care clients in both civil and administrative litigation, including at the Court of Appeals, in a variety of contexts, including medical malpractice defense, peer review, medical staff matters, Certificate of Need and other regulatory and business disputes.
Liz is a contributing author on Fox Rothschild's North Carolina Appellate Practice Blog, which provides news, information and tips for practicing law in North Carolina's State and Federal Appellate Courts.
Liz earned her B.A., with highest honors, in Journalism and Mass Communication with a concentration in Public Relations from University of North Carolina at Chapel Hill and her J.D., with honors, University of North Carolina School of Law.
Liz is active in the community, serving as President of the board of directors for Artsplosure, Raleigh's nonprofit art and cultural events production studio. She is a former member of the executive leadership team of the American Heart Association's Triangle Go Red for Women and a member of its Circle of Red. Liz is also the former President of the Eastern District of North Carolina Federal Bar Association and is still a member of its Executive Board. She is also active in Triangle CREW.
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Marcus C. "Marc" Hewitt is a partner in the Raleigh office of Fox Rothschild and has practiced in the areas of health care and administrative litigation for almost 20 years. His practice focuses on administrative litigation, regulatory matters and a variety of commercial and business disputes. He represents hospitals, dialysis providers, diagnostic service providers, nursing facilities and other private providers and handles commercial disputes in state and federal courts, as well as state administrative litigation matters including Certificate of Need (CON) matters, licensure matters, and state government contract matters for external quality review organizations (EQROs) and Medicaid Prepaid Health Plans.
Marc also advises health care providers and related entities such as dental support organizations (DSOs) and HMOs on regulatory compliance, contracting and related issues before the North Carolina Department of Health and Human Services, professional licensing boards and North Carolina Department of Insurance.
Marc earned his B.A., with distinction, in Economics from the University of North Carolina at Chapel Hill and his J.D. from the University of North Carolina School of Law.
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Jennifer Csik Hutchens is a shareholder and corporate health care attorney at Robinson Bradshaw & Hinson PA in Charlotte. She co-chairs the firm's Health Care Practice Group. She represents health care providers, ancillary service providers, licensed agencies, nonprofits, management services organizations and other industry-based clients of all sizes.
Jennifer's transactional practice is focused on joint ventures, mergers and acquisitions, and other affiliation and collaboration transactions, as well as health care contracting matters (professional services, managed and value-based care, and other contracts). She also serves as outside general counsel to several health care clients.
Jennifer has deep experience interpreting federal and state health care guidance, including the Anti-Kickback and Stark laws, corporate practice of medicine and fee-splitting prohibitions, scope of practice rules, surprise/balance billing laws and price transparency rules. She regularly advises clients on topics in health innovation, ranging from telehealth to concierge medicine.
Jennifer earned her B.A., summa cum laude, in Political Science from Duke University and her J.D., magna cum laude, from Duke University School of Law.
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Vonne M. Jacobs is of counsel with Hall Render Killian Heath & Lyman PC in Raleigh. She focuses her practice in the area of health care transactions. Calling upon her years of dedicated experience, Vonne provides practical, pragmatic advice to help her clients achieve their strategic goals.
Within the highly regulated health care industry, Vonne advises clients, including hospitals, health systems, AMCs and large physician groups, on transactions. She serves as a regulatory advisor, providing fraud and abuse analysis in the context of a deal and ensuring her clients remain compliant with the regulations that govern health care transactions.
Vonne is a member of the American Health Law Association and serves on the Development and Advancement Council. She is also a Board member for the Lucy Daniels Center, a non-profit that focuses on children with behavioral needs. Additionally, she is an active member of Delta Sigma Theta Sorority Inc., through which she participates in local community service.
Vonne earned her B.A. in Business Administration/Computing Business from Furman University and her J.D. from Duke University School of Law.
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Allyson J. Labban is Associate General Counsel at WakeMed in Raleigh. She provides regulatory compliance guidance on topics ranging from HIPAA and data privacy and security, Medicare and Medicaid claims filing requirements, compliance with CMS and Joint Commission standards, and Certificate of Need and facility licensure issues, as well as guidance regarding risk management and clinical-legal issues.
Prior to joining WakeMed, she was a partner and health care attorney at Smith Moore Leatherwood LLP, now Fox Rothschild LLP, in Greensboro.
Allyson earned her B.A. in Spanish and History from Wofford College and her J.D. from Duke University 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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Patricia A. "Trish" Markus is a partner at Nelson Mullins Riley & Scarborough LLP in Raleigh. She represents healthcare providers and related organizations across the country on an array of healthcare regulatory compliance, reimbursement, licensure, and operational matters, with a special focus on issues surrounding health information privacy, security, and technology. She provides strategic and practical advice regarding HIPAA and other data privacy and security laws, information blocking and interoperability requirements, telehealth and health information exchange initiatives, technology licensing and services arrangements, cybersecurity risks and data breach prevention and response, clinical research and patient care issues, and compliance and fraud and abuse matters. She also works with physicians, hospitals, accountable care organizations, post–acute care facilities, behavioral health and substance use disorder facilities, and pharmacies on licensure and reimbursement matters, acquisitions, and divestitures. She writes frequently and speaks nationally on healthcare topics.
A frequent author and speaker, Trish currently serves as the President-Elect of the American Health Law Association and is a past Chair of AHLA's Health Information and Technology Practice Group. A Fellow of the American Bar Foundation, she is listed in Chambers USA in Healthcare, North Carolina Super Lawyers in Health Care and as one of the "Top 50 Women" attorneys in North Carolina (2015), and she has been listed in Best Lawyers in America, Health Care Law, annually since 2009.
Trish earned her B.A., with honors, in English from Haverford College her J.D. from Boston College Law School.
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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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Robert W. Shaw is a partner in the Raleigh law firm of Smith Anderson Blount Dorsett Mitchell & Jernigan LLP in Raleigh. He has extensive experience in solving health care and tax challenges important to clients. He regularly handles complex restructuring, M&A work on the buyer side and seller side, Medicare and Medicaid audits, tax planning and controversy, hospital joint ventures, employment agreements, corporate advice and regulatory compliance. He has represented clients in acquisitions, including public company hospitals, private equity firms and regional and national health care providers across the country. Robert has represented clients in tax controversies involving a broad range of issues at federal, state and local levels in multiple jurisdictions.
Robert's robust health care regulatory practice includes advising clients with respect to Medicare/Medicaid compliance, accountable care organization regulations, heath care antitrust, HIPAA, Anti-Kickback Statute, and Stark Law matters around the country. He has advised health care clients with respect to CLIA certification, enrollment and credentialing issues, managed care organization relations, and Affordable Care Act compliance. He has broad experience with regulatory compliance issues faced by ambulatory surgical centers, hospitals, physician groups, developmental disabilities providers, home health and hospice providers, substance abuse clinics, mental health providers, skilled nursing companies, and speech therapy agencies.
Robert earned his B.S. in Mathematical Economics from Wake Forest University and his J.D. from University of North Carolina School of Law.
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Sean A. Timmons is a shareholder at Polsinelli PC in Raleigh. He draws on a wealth of practical experience and solid understanding of the health care industry, coupled with a firm grasp of substantive law in this highly regulated environment to craft an effective legal strategy to assist clients in reaching their business goals. He advises clients on complex regulatory issues affecting their key strategic initiatives and has extensive experience counseling clients on clinical integration activities, including hospital-physician contracting, such as professional services agreements, service line co-management agreements, and hospital efficiency agreements and development and ongoing representation of clinically integrated networks (CINs) and accountable care organizations (ACOs). He has extensive experience advising all types of clients on compliance with federal and state fraud and abuse laws and regulations, including the Stark and anti-kickback laws. He regularly assists clients on acquisitions and joint ventures involving healthcare entities. He also regularly advises clients on state and federal laboratory regulation.
Sean earned his. B.A., cum laude, in English and Music from Williams College and his J.D. from Duke University School of Law.
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