AHLA Telehealth Law Handbook (Non-Members)

Jennifer R. Breuer, editor of this title and author of Chapter 1, is Vice Chair of Faegre Drinker’s Health Care Practice Group and Co-Chair of its Digital Health Team. Ms. Breuer provides strategic counsel to hospitals, health systems, physician practices, other providers, and health technology companies on the transactional, regulatory, and compliance matters they must address in the rapidly evolving health care landscape. She also develops data-sharing and privacy compliance strategies related to the use of electronic health records, health information exchanges, and other technology platforms. Ms. Breuer assists with the formation and operation of telehealth companies and counsels them on regulatory and compliance matters including privacy law, contracting, risk reduction, and breach response. She develops policies, procedures, and compliance programs to ensure compliance with state and federal regulations such as the Medicare and Medicaid Anti-Kickback Statute, Stark Law, HIPAA and 42 C.F.R. Part 2. Ms. Breuer earned a J.D. from Northwestern University Pritzker School of Law and a B.A. from Wesleyan University.

Jessa Boubker, co-author of Chapter 9, is a health care and life sciences lawyer with Foley & Lardner LLP. She is a member of the firm’s Health Care Practice Group. Ms. Boubker’s practice focuses on a broad range of federal and state regulatory compliance, transactional, and business matters for health industry clients. She helps advise clients on regulatory compliance considerations when developing and commercializing pharmaceutical and medical device products, including software as a medical device, and regularly assists clients in the development and maintenance of clinical trial compliance programs. She has also worked with a number of digital health companies to launch and scale their direct-to-consumer telehealth platforms and operations throughout the United States. Prior to joining Foley, Ms. Boubker served as the Editor-in-Chief of the American Journal of Law and Medicine. She earned a J.D. from Boston University School of Law, an M.P.H. from Boston University School of Public Health, and a B.A. from Smith College.

Kyle Y. Faget, co-author of Chapter 9, is a partner and business lawyer with Foley & Lardner LLP. She is the Co-Chair of the firm’s Health Care & Life Sciences Sector—Medical Devices and a core member of the firm’s life sciences and telemedicine industry teams. Ms. Faget advises investors, academic medical centers, physician practices, and consultants on a range of business, legal, and regulatory issues affecting the telemedicine industry. She helps companies build and refine corporate compliance programs including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code, and the PhRMA Code. She regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products, including licensing agreements, collaboration agreements, clinical trial agreements, and an array of services agreements. Prior to joining the firm, Ms. Faget held in-house positions at pre- commercial and commercial stage companies. She earned a J.D. from the University of Michigan Law School, a certificate in post-baccalaureate pre-medical studies from Bryn Mawr College, and an A.B. in physiological psychology, with a minor in neuroscience, from Smith College.

Andrea L. Frey, co-author of Chapter 2, is a partner at Hooper, Lundy & Bookman as well as Co-Chair of the firm’s Digital Health Practice Group and Reproductive Health Practice Group. She regularly counsels health care providers and suppliers on a wide range of transactions and regulatory matters, with a particular expertise in digital health. Ms. Frey’s experience includes assisting clients navigate the complex web of state and federal health privacy laws, state-level scope of practices issues (e.g., licensure, informed consent, practitioner-patient relationship establishment), corporate practice of medicine, and remote prescribing. Throughout the COVID-19 pandemic, she has also helped clients parse through the rapidly evolving federal and state developments and regulatory changes, particularly with regard to the provision of telehealth services, and frequently counsels clients on the development and operation of nation-wide digital health care platforms and other business lines. Ms. Frey earned her undergraduate degree from Tufts University and her law degree and master of public health from the University of Washington.

Adam H. Greene, author of Chapter 7, is a partner in the Washington, D.C. office of Davis Wright Tremaine LLP. He primarily counsels health care providers, technology companies, and financial institutions on compliance with health information privacy, security, breach notification, and information blocking rules. Previously, Mr. Greene was a regulator at the U.S. Department of Health and Human Services, where he played a fundamental role in administering and enforcing the HIPAA rules. At HHS, he was responsible for determining how HIPAA rules apply to new and emerging health information technologies and was instrumental in the implementation of the HIPAA enforcement process. Mr. Greene has been recognized as a Band 1 Privacy and Data Security attorney in Healthcare by Chambers and Partners, one of the top ten influencers in health information security, one of the top 50 health care IT experts, and is a frequent speaker and author on health information privacy and security and information blocking issues. He earned a J.D. from the George Washington University Law School, a Master of Public Health with a concentration in Epidemiology from the George Washington University Milken Institute School of Public Health, and a B.A. in Biology from the Johns Hopkins University.

Jennifer A. Hansen, co-author of Chapter 2, is an equity partner at Hooper, Lundy & Bookman and the Co-Chair of the firm’s Medical Staff Practice Group. She advises on telehealth credentialing issues and represents health care providers in a wide range of litigation. A significant portion of Ms. Hansen’s practice involves advising medical staffs in credentialing and privileging matters, governance, by-laws, policies and procedures, rules and regulations, investigations, and reporting to the state professional licensing boards and the National Practitioner Data Bank. Her representation of health care providers also includes payor/provider disputes and post-acute care facility defense. Ms. Hansen earned her undergraduate degree from the University of Wisconsin-Madison and her law degree from the University of Minnesota Law School.

Elinor A. Hiller, co-author of Chapter 5, is a partner in Alston & Bird’s Health Care Policy practice. Along with Sean Sullivan, she co-leads the firm’s Digital Transformation of Health Care initiative. Ms. Hiller represents clients across the health care industry on legislative and regulatory policy matters, with a focus on Medicare Advantage and Part D, Medicare fee-for-service payment rules, interoperability and price transparency, and federal insurance oversight. She previously served at the Centers for Medicare and Medicaid Services (CMS) and was an advisor to the CMS Administrator on issues including Medicare, telehealth, and price transparency. Earlier in her time at CMS, Ms. Hiller was the director of the Medicare Parts C and D Analysis Group in the Office of Legislation, where she managed interactions between the agency and Capitol Hill on a portfolio of issues including provider integrity. Ms. Hiller is a graduate of Georgetown University Law Center and Wellesley College.

Melania Jankowski, co-author of Chapters 3 and 6, is an associate in the Boston office of Orrick, Herrington & Sutcliffe. She assists health care providers, suppliers, and investors on issues involving transactions, regulatory compliance, corporate governance, and innovative business arrangements. Ms. Jankowski focuses largely on working with national telehealth platforms and digital help startups, helping them navigate various state-level scope of practice, licensure, and corporate structuring and scaling considerations. Previously, she worked as an associate for a national health law firm and also served as a law clerk for the Federation of State Medical Boards, where she gained invaluable experience tracking medical licensure and telehealth waivers during the COVID-19 pandemic. She earned a J.D. from Boston College Law School.

Amy M. Joseph, co-author of Chapter 6, is a partner in the Boston office of Orrick, Herrington & Sutcliffe. She advises a wide variety of health care providers and related entities, including telehealth platforms and startups, health systems, health care information technology companies, management organizations, physician groups, pharmacies, and health care investors on business and regulatory matters. A significant portion of Ms. Joseph’s practice is focused on fraud and abuse compliance, including counseling and advice regarding compliance of potential business structures with federal and state anti-kickback and self-referral laws, health information privacy and security, mergers and acquisitions, and other strategic affiliations. She earned a J.D. from UCLA School of Law.

Amy Lerman, author of Chapter 4, is a Member of the Health Care and Life Sciences Practice at Epstein Becker & Green, P.C. (EBG). Ms. Lerman’s diverse practice includes guiding EBG’s telehealth clients through their “life cycle” of legal needs. She helps these clients develop and execute strategies for company structure, development, and growth, while also advising on trends and the development of regulatory strategies for growing and expanding telehealth businesses to achieve nationwide footprints. Ms. Lerman also supports EBG’s clients on matters involving government investigations, audits, and related claims of fraud, false claims, and other noncompliant behaviors as well as a broad scope of regulatory questions, advising on compliance-related questions, and the development of corporate compliance program infrastructures. Ms. Lerman earned her Masters in Public Health from Columbia University and her J.D. from the University of Maryland. She is the lead author of EBG’s Telemental Health Laws app, a comprehensive survey of state telehealth laws, regulations, and policies for mental and behavioral health practitioners and stakeholders across all 50 states, the District of Columbia, and Puerto Rico. Ms. Lerman also has guest lectured on digital health law at Cornell Tech since 2018.

Joseph P. (“Joe”) McMenamin, M.D., J.D, co-author of Chapter 8, is a physician-attorney and a partner with Christian & Barton, LLP in Richmond, Virginia concentrating on the law of digital health. Mr. McMenamin advises institutional and professional telehealth service providers, academic medical centers, remote monitoring services, trade associations, telehealth platform companies, private equity firms, and telecoms on a broad array of medico-legal questions arising from distance care and, more recently, on the application of augmented intelligence to health care in general and to telemedicine in particular. He writes and lectures extensively on these and related topics. Mr. McMenamin also serves as general counsel to the Virginia Telehealth Network. He is a member of the Legal Resource Team of CTeL, the Center for Telemedicine and eHealth Law, and of the Board of Trustees of the American Board of Legal Medicine. He graduated summa cum laude from Washington and Lee with a B.S. in chemistry and holds medical and law degrees from the University of Pennsylvania. He trained in internal medicine at Emory University and Grady Memorial Hospitals in Atlanta.

Rachel V. Rogers, J.D., co-author of Chapter 8, is an associate with Christian & Barton, LLP in Richmond, Virginia where she practices in the health care and business law practice groups. Ms. Rogers advises clients on a variety of general health matters, including state and federal regulatory compliance, managed care agreements, telehealth, reimbursement issues, Medicare and Medicaid concerns, breach of health records requirements, and general corporate matters. Ms. Rogers serves as the Young Lawyers Division Representative to the Virginia Bar Association Health Law Section. She graduated summa cum laude from West Virginia University with a B.S. in journalism and holds a law degree, cum laude, from the College of William & Mary Law School.

Kerry K. Sakimoto, co-author of Chapter 2, is an associate at Hooper, Lundy & Bookman. Mr. Sakimoto’s practice focuses on transactional and health care regulatory matters, including digital health and health technologies, privacy, and the corporate practice of medicine. He is a member of the firm’s Digital Health Practice Group and its Reproductive Health Practice Group. Mr. Sakimoto holds a B.A. degree from Occidental College and a J.D. degree from UCLA School of Law, where he previously served on the UCLA Law Review and the UCLA Journal on Law and Technology.

Jeremy D. Sherer, co-author of Chapters 3 and 6, is a partner in the Boston office of Orrick, Herrington & Sutcliffe. Mr. Sherer is a nationally recognized telehealth expert who represents health care providers and suppliers including hospital systems, provider organizations, national telehealth platforms, and digital health startups on issues involving regulatory compliance, transactions, and innovative business arrangements. He has been interviewed by publications including Modern Healthcare, Bloomberg BNA, and MedCity News and has presented on telehealth matters to organizations including the Federation of State Medical Boards and the National Association of Medicaid Fraud Control Units and at conferences held by the American Health Law Association, the American Bar Association’s Health Law Section, the Center for Connected Health Policy, the National Consortium of Telehealth Resource Centers, and the Health Care Compliance Association. Mr. Sherer has also contributed telehealth chapters to a variety of health law treatises and participated in the formation of the Uniform Law Commission’s Model Telehealth Act.

Sean T. Sullivan, co-author of Chapter 5, is a partner with Alston & Bird’s Health Care Group and co-leads the firm’s Digital Transformation of Health Care team with Elinor Hiller. Mr. Sullivan assists health care providers and business associates, including health care technology companies, in maintaining regulatory compliance; understanding billing and reimbursement matters; advising on business forms and transaction structures; investigating, disclosing, and resolving potential noncompliance; and providing regulatory support to litigation and transactions as necessary. He also regularly advises private equity and other investors on the regulatory risks and structuring considerations associated with investing in the health care industry. Mr. Sullivan started his legal career in the U.S. Army JAG Corps, where he advised commanders on regulatory matters and defended soldiers and officers accused of misconduct in courts martial and hearings. Since leaving active duty, Mr. Sullivan has focused his career on advising national health care providers in regulatory actions, policy review, compliance, reimbursement, and liability prevention, including corporate practice of medicine, HIPAA, Stark Law, Anti-Kickback Statute, False Claims Act, and CMS rules. Mr. Sullivan earned his J.D., cum laude, from Georgia State University College of Law and his B.A. from Emory University.

Christine Burke Worthen, co-author of Chapter 3, is a Member of the Firm at Epstein Becker Green. Health care providers, payers, digital health companies, and investors call on her for legal and strategic advice as they navigate complex regulatory and business challenges in the continuously evolving health care delivery and reimbursement landscape. Ms. Worthen’s practical guidance enables clients across the health care ecosystem—including health systems, hospitals, physician practices, digital health companies, behavioral health providers, third-party administrators, health plans, telehealth, and investors—to implement both short- and long-term strategies that align with their organizational goals.

With a wealth of experience, Ms. Worthen focuses on matters concerning Medicare reimbursement, Medicare Advantage, participation in CMS Innovation Center payment models, managed Medicaid, managed care contract negotiations, and value-based payment arrangements with commercial payers, self-insured employers, and Medicare Advantage plans. She provides counsel on the regulatory, operational, and financial considerations necessary for maneuvering through the changing payment environment, including various forms of risk-based payment models, price transparency, revenue cycle and payment integrity, clinically integrated network development and value-based enterprise models, risk adjustment, and provider compensation arrangements.