8:55 Welcome and Introductions
9:00 Exploring the New Stark and Anti-Kickback Landscape: Flexibilities for Providers and Value-Based Care in a Post-COVID Environment
Kelsey U. Jernigan, K&L Gates LLP, Research Triangle Park
Steven G. "Steve" Pine, K&L Gates LLP, Research Triangle Park
While providers navigate a sea of waivers and exceptions related to COVID-19, significant changes to the federal Stark Law, Anti-Kickback Statute and Civil Monetary Penalties Law are shaping provider collaboration and the fraud and abuse landscape for years to come. These long-awaited final rules contain significant accommodations for value-based care models, while modernizing the regulations in an aim to align with the current health care industry. This presentation explores how the health care industry can utilize these accommodations to pursue value-based care in a post-COVID environment.
10:03 Break
10:13 Telehealth Opportunities — For Patients, Profits, Personnel, Prosecutions and Penetration‡
Christian P. Dennis, Chilivis Grubman Dalbey & Warner LLP, Atlanta, GA
Barry S. Herrin, Herrin Health Law PC, Atlanta, GA
Jennifer B. "Jenny" Markham, UNC Healthcare System, Chapel Hill
COVID accelerated the adoption and deployment of remote diagnostic (telehealth) services faster than anyone thought possible. However, the speed of telehealth' adoption also created opportunities for health care fraud and the proliferation of cybercrime throughout the healthcare industry. The panelists discuss how health care providers have operationalized telehealth in their service offerings, continuing challenges in telehealth reimbursement, the growth of telehealth-enabled fraud, the impact of cybercrime on the increased "attack surface" created by telehealth, and adjustments required due to more workplaces being converted to "work from home" and away from traditional office environments.
11:50 Lunch Break
12:20 Managing Health Care Internal Investigations
Pearlynn G. Houck, Robinson Bradshaw & Hinson PA, Charlotte
Jonathan C. Krisko, Robinson Bradshaw & Hinson PA, Charlotte
An effective internal investigation depends upon the expertise and competence of a company's legal counsel and investigation team. Internal investigations have become larger and more complex, particularly in the healthcare industry, which presents unique risks of legal and regulatory pitfalls. The presenters discuss best practices in conducting healthcare-related investigations and the range of issues that may arise including privilege, document retention and preservation, confidentiality, employment-related complexities, and additional issues resulting from the COVID-19 pandemic.
1:57 Break
2:07 An Ounce of Prevention: Best Practices for an Effective Compliance Program
R. Ross Burris III, Polsinelli, Atlanta GA
Neal I. Fowler, United States Attorney's Office, Raleigh
Ted Lotchin, WakeMed Health & Hospitals, Raleigh
In an industry that is always evolving, one constant remains: a robust compliance program is the best medicine for protecting against serious regulatory risks and promoting ethical behavior. Panelists discuss best practices for implementing an effective compliance program and review recent guidance from the Department of Justice and the Office of the Inspector General. Dive into a discussion on strategies for developing, implementing, and improving corporate compliance initiatives.
3:10 Health Care Policy: The Winding Road Ahead
Karishma S. Page, K&L Gates LLP, Washington, DC
In the midst of a pandemic, a new president, and many other changes inside the Beltway, including a likely Supreme Court decision on the constitutionality of the Affordable Care Act, health care policymakers have their hands full in 2021. This session discusses what to expect from President Biden's administration, how the pandemic will help shape health policy in 2021 and beyond, the current state of the Affordable Care Act, and other key health policy developments that will undoubtedly have a dramatic effect on the health care industry going forward.
4:10 Adjourn
‡ Indicates portion providing Technology Training credit
Thank you for joining us for The New Normal Is That Nothing Is Normal (2021 Health Law Section Program).
The ongoing pandemic and the transition to a new presidential administration are expected to have significant and lasting impacts on the health care industry, requiring health care providers, payors, and policymakers, and the lawyers who serve them, to continually evolve in the coming months and years.
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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R. Ross Burris, III is a shareholder with Polsinelli in Atlanta, GA. He benefits clients by applying a strong business acumen to understanding the goals and challenges clients face, and by leveraging a commanding ability to counsel on intricate legal matters. His experience includes advising clients regarding the complex and ever-changing federal and state regulatory environment. Ross approaches each issue with a practical application that is unique to the client's context and draws on a strong background of working with numerous regional and national health care providers.
Ross's compliance work encompasses numerous federal and state health law requirements, including Medicare Reimbursement Audits, Medicaid issues and Commercial Payor disputes and Medicare billing guidelines. Ross is a former prosecutor and actively involved in the Atlanta community as a member of the Advisory Council for the Health Law Partnership (HeLP) and an Executive Committee Member for the Young Professionals Council of the Georgia Appleseed Center for Law and Justice. He is a frequent speaker and author for the American Health Law Association (AHLA), Health Care Compliance Association (HCCA), and the Georgia Hospital Association (GHA). Ross has been recognized several times by Super Lawyers in the area of Health Care.
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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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Christian P. Dennis is an Associate of Chilivis Grubman Dalbey & Warner LLP in Atlanta, GA. Christian handles civil and criminal matters, including government investigations, False Claims Act litigation, and white-collar criminal defense. Christian also handles administrative and regulatory matters including Medicare/Medicaid reimbursement appeals, internal investigations, medical board matters, compliance and counseling, and HIPAA matters. Before joining Chilivis Grubman, Christian defended medical providers and institutions in medical malpractice, administrative, and employment matters. Although the majority of Christian's clients are in the healthcare industry, he also represents clients in a wide variety of other industries in general liability and complex litigation claims.
Christian is a member of the State Bar of Georgia, American Health Lawyers Association (AHLA) and the Atlanta Bar Association. He received his B.B.A. degree from Georgia State University and his J.D. degree from Georgia State University College of Law.
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Neal I. Fowler is an attorney with the United States Attorney's Office in Raleigh. Mr. Fowler is a member of the North Carolina Bar Association. He received his B.B.A. degree from the University of Mississippi and his J.D. degree from Duke University School of Law.
John B. Garver III, Robinson Bradshaw & Hinson PA, Charlotte
John practices in the areas of health care, joint ventures and insurance law. He has a broad transactional health care practice, including assisting hospitals and health systems, physicians and their practices, and dialysis providers in structuring and closing acquisitions, affiliations, joint ventures and ownership transfers. John also advises clients on compliance and regulatory issues, including the Anti-Kickback and Stark laws, self-audits, overpayments and self-reporting. He served as a longtime leader of the firm's Health Care Practice Group and frequently writes and speaks on health law issues.
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Barry S. Herrin is the founder of Herrin Health Law PC in Atlanta, GA. He regularly advises his clients on a wide variety of transactional and regulatory issues, including operations and compliance, mergers and acquisitions, medical information privacy and confidentiality, cybersecurity and data breach response, insider threat mitigation, and the formation of alternative payment model structures.
Barry is one of very few attorneys in the United States that is both a Fellow of the American College of Healthcare Executives and a Fellow of the American Health Information Management Association, recognitions of his professional qualifications beyond the law. He also holds a Certificate in Healthcare Privacy and Security from the American Health Information Management Association, a credential shared by many professional healthcare information managers, as well as a Certificate in Cyber Security from Georgia Tech in Atlanta.
Barry retired in 2015 as a colonel in the U.S. Air Force Auxiliary, in which his last duty station was as the Chief Judge Advocate for the Auxiliary. He is an Eagle Scout, an active member of the Forsyth County Sheriff's Office Volunteer Unit, and is a certified barbecue judge.
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Pearlynn G. Houck is a member of Robinson Bradshaw & Hinson, P.A. in Charlotte. She is a versatile litigator and adviser. She represents companies and executives in complex business disputes, investigations and bet-the-company litigation. She has experience in matters involving fraud, breach of contract, unfair trade practices, financial products, securities, corporate governance, professional negligence and class actions.
Pearlynn regularly represents clients in noncompetition, trade secret and other employment disputes, conducts internal investigations, and assists clients in responding to government inquiries. She also co-chairs the firm's Government and Internal Investigations Practice Group.
Pearlynn's clients benefit from her courtroom experience. She has argued injunctions, temporary restraining orders and dispositive motions, participated in multiple jury trials and arbitrations, and litigated appeals in the North Carolina Court of Appeals and U.S. Courts of Appeals. Pearlynn received her B.A. degree with honors from the University of Montana in 2002 and her J.D. degree from Harvard Law School in 2005.
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Kelsey U. Jernigan is a partner in K&L Gates' Research Triangle Park office. Kelsey's practice focuses on all areas of health care regulatory, compliance and transactional law for hospitals, health systems, academic medical centers and other health care providers. She concentrates on potential Stark Law and Anti-Kickback Statute matters; hospital contracting with physicians, health care providers and vendors; and assisting clients with various operational matters, including medical staff and risk management issues.
Kelsey regularly conducts internal reviews of hospital clients’ financial arrangements with physicians and has assisted numerous clients in filing disclosures under the Stark Self-Referral Disclosure Protocol. She routinely analyzes complicated Anti-Kickback Statute and Civil Monetary Penalty matters and has drafted and submitted multiple Advisory Opinion requests to the OIG. Kelsey has experience advising hospitals on EMTALA issues, and counseling health care providers through licensure issues and adverse survey citations. In addition, Kelsey assists in all stages of affiliations and transactions between health care providers, ranging from due diligence, compliance and transactional matters, and preparation and submission of change of ownership filings.
Kelsey attended the University of North Carolina at Chapel Hill for both her undergraduate degree and her law degree. Prior to attending law school, Kelsey worked for two health care systems in public relations and government affairs.
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Jonathan C. "Jon" Krisko is a member of Robinson Bradshaw & Hinson, P.A. in Charlotte. He represents clients in complex, business-related litigation, which has included matters involving health care, product liability, technology, and government and regulatory investigations. His experience includes trials, arbitrations and appeals in federal and state courts.
Jon has represented public and private companies and individuals in high-stakes contractual and commercial disputes. His representations include multiparty cases, and mass and class actions in federal court, bankruptcy court and the North Carolina Business Court. In addition, Jon regularly counsels business clients as outside general counsel and oversees internal and government investigations. He serves as co-chair of the firm's Government and Internal Investigations Practice Group.
Jon is a member of the International Association of Defense Counsel. He received his B.A. degree from Duke University in 1995 and his J.D. degree with high honors from the University of North Carolina at Chapel Hill in 2002.
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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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Jennifer B. "Jenny" Markham is the System Vice President and Deputy General Counsel with UNC Healthcare System in Chapel Hill. Jenny is a member of the North Carolina Bar Association.
Jenny received her B.A. degree in Political Science from the University of North Carolina at Chapel Hill in 1999 and her J.D. degree from the University of Richmond School of Law in 2003.
Allen T. O'Rourke co-chairs the Cybersecurity and Privacy Practice Group at Robinson Bradshaw and is an IAPP Certified Information Privacy Professional (CIPP/US and CIPP/Europe). He leads cyber investigations, helps clients respond to data breaches, and represents clients facing lawsuits and government investigations arising out of cybersecurity incidents. Allen also provides legal guidance on privacy and data security law as well as digital advertising and analytics.
Before entering private practice, Allen was a cybercrime prosecutor who helped lead the Cyber Unit at the US Attorney's Office in Washington, DC, where he received two Special Achievement Awards for his work to combat cybercrime.
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Karishma S. Page is a member of K&L Gates LLP in Washington, DC. She is a member of the firm's public policy and law practice. Karishma concentrates her practice on federal legislative and regulatory policy, focusing on tax, financial services, health care, retirement, and employee benefits issues. She has extensive experience working on a variety of legislation, such as the Tax Cuts and Jobs Act, the Protecting Americans from Tax Hikes Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, and the Affordable Care Act. She also works on related rulemaking and regulatory activity.
Karishma develops and implements a variety of advocacy strategies to advance client objectives, both from a Congressional and administrative perspective. In particular, she leads complex, multi-faceted policy campaigns incorporating lobbying, coalitions and third-party advocates, grassroots/grasstops strategies, and traditional and new media. Additionally, she has experience building, managing, and working with coalitions.
Karishma works closely on issues involving the House Ways and Means Committee, Senate Finance Committee, House Financial Services Committee, Senate Banking Committee, House Education and the Workforce Committee, Senate Health, Education, Labor, and Pensions Committee, and Senate Aging Committee, as well as the Department of the Treasury, Internal Revenue Service, Department of Labor, and financial regulators.
She received her B.A. degree from the University of Michigan in 2002, her M.P.P. degree from the University of Michigan in 2003 and her J.D. degree from Georgetown University Law Center in 2008.
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Steven G. "Steve" Pine is a partner with K&L Gates LLP in Research Triangle Park. He is in the firm's health care practice group. He concentrates his practice on the intersection of health law compliance and dispute resolution, primarily representing public and private academic medical centers, hospitals, and health systems. His areas of focus include certificate of need contested cases; governmental and nongovernmental payment and reimbursement; health privacy; HIPAA and Common Rule research compliance; clinically integrated network (CIN) formation; alternative payment models and value-based reimbursement; federal False Claims Act litigation; administrative reconsiderations, reviews and appeals (e.g., EMTALA QIO hearings, RAC appeals and hearings, UPIC/ZPIC appeals); and Affordable Care Act compliance.
Steve joined K&L Gates as a summer associate in 2011. Prior to attending law school, Steven was a commercial real estate broker with a regional land development company.
Steve is a member of the North Carolina Society of Health Care Attorneys' Board of Directors (Chair of Governance and Planning Committee), American Health Lawyers Association, North Carolina Bar Association and the Wake County Bar Association.
Steve earned his B.S., summa cum laude, from North Carolina State University and his J.D. from Harvard Law School.
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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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