The following is an excerpt from Practice Perspectives: Vault's Guide to Legal Practice Areas.
Heather O'Shea is a co-leader of the firm's Health Care & Life Sciences practice. For more than 20 years, she has represented clients in federal and state government investigations and litigation involving fraud and abuse enforcement, including the False Claims Act (FCA), the Anti-Kickback Statute (AKS), Stark Law, and Medicare and Medicaid reimbursement. Heather represents clients on regulatory and compliance matters involving Medicare and Medicaid, fraud and abuse laws, reimbursement regulations, the Physician Payments Sunshine Act (Open Payments), clinical research compliance, and U.S. Food & Drug Administration (FDA) regulations. She has extensive experience conducting internal investigations, handling voluntary disclosures, and counseling clients on refunds to Medicare. Heather also has significant experience advising clients on compliance program development and implementation, and conducting assessments of existing compliance programs.
Laura Koman represents healthcare and life sciences companies on complex regulatory and compliance matters in emerging areas. Laura advises large healthcare systems and national provider organizations on unique legal, regulatory, and reimbursement structures impacting the remote delivery of healthcare services and multijurisdictional digital health strategy. Laura also represents global life sciences organizations on the contractual, regulatory, and ethical issues associated with clinical research, including those related to decentralized clinical trials and clinical trial diversity initiatives.
Describe your practice area and what it entails.
The Health Care & Life Sciences practice at Jones Day is a multidisciplinary team of lawyers who represent clients across the entire healthcare and life sciences spectrum, from hospital systems and academic medical centers to provider organizations, healthcare investors, and emerging companies, along with leading and startup pharma, biotech, medical device, digital health, and food and cosmetics companies in matters ranging from litigation, transactional, compliance, and regulatory. Our firm’s approach to the health sector—with an integrated global health industry team of more than 300 lawyers—affords us the opportunity to work with colleagues in other practices to best serve the firm’s health industry clients.
What types of clients do you represent?
We represent clients across the industry—from traditional healthcare provider organizations (hospitals, academic medical centers, post-acute care facilities, skilled nursing and rehabilitation centers, senior care facilities, physician groups, urgent care and ambulatory surgery centers, and telehealth/telemedicine organizations), to emerging technology and digital health enterprises, healthcare investors (PE/VC funds), manufacturers and developers of healthcare products (pharmaceuticals, biologics, medical devices, food/dietary supplements, cosmetics, tobacco products), and outsourced vendors (contract research organizations, contract manufacturers).
What types of cases/deals do you work on?
Heather: My practice focuses on government enforcement—investigations and litigation involving the False Claims Act at the federal and state levels. Given the matters I work on, my practice also involves regulatory and compliance counseling. I am able to see both sides of the coin, so to speak—areas that the government is focused on, but also best practices and business solutions for addressing issues in a compliant manner.
How did you choose this practice area?
Laura: One of the things that drew me to Jones Day in the first place is the firm’s New Lawyers Group—a program that offers first-year lawyers exposure to a variety of practices and lawyers across the firm before officially joining a particular practice group. I knew that I was interested in joining a practice that allowed me to work with complex statutes and regulations, interact with regulators, and work on both litigation and transactional matters, and I tried projects in several different regulatory focused practices during my first year. My very first assignment, though, was a healthcare matter that involved interpreting state regulations in the context of remote optical health services, and I was immediately hooked. I worked directly with a partner who is an expert in the telehealth space and got to research recently enacted state regulations, interact with state regulators regarding the interpretation of the regulations, and participate in the client call to deliver our guidance. I loved it!
What is a typical day like and/or what are some common tasks you perform?
Laura: One thing that I enjoy about this practice is that every day looks a little bit different. Nearly every day involves some sort of legal research, typically looking at federal or state statutes and regulations and related agency guidance to advise clients on questions that often do not have a clear-cut answer. I also do a good amount of drafting, whether it’s a formal memo containing a regulatory analysis, helping clients draft documents to set up appropriate corporate and regulatory-oriented structures for their healthcare arrangements, or drafting and advising on commercial agreements. No matter what I am working on, it usually involves close collaboration and communication with clients and with others at the firm. I am frequently collaborating with Health Care and Life Sciences lawyers in other offices (we have a presence in nearly every U.S. office, as well as globally) and with lawyers in other practice groups. Jones Day’s commitment to client service means that we bring in the right lawyers with the right experience to deliver the best work product for our clients, regardless of practice designation or office location. This is great for associates, who get the chance to work with a lot of different people and see how a big project comes together.
What training, classes, experience, or skills development would you recommend to someone who wishes to enter your practice area?
Heather: While a background in healthcare is always helpful, it is certainly not required. Given the multidisciplinary nature of our practice, we look for associates with a wide set of skills and experience. As far as classes, we would definitely recommend taking Administrative Law, where possible, because understanding how federal agencies like the Department of Health & Human Services operate is a critical component of our practice. Drafting, negotiations and mediation, and trial advocacy skills are all areas that would be beneficial.
What is the most challenging aspect of practicing in this area?
Heather: I think one of the most challenging aspects of this practice is also one of the best—this is a fast-paced industry driven by science, innovation, and an incredibly complex legal framework that is itself evolving at a rapid pace. The firm’s approach to client service allows us to access knowledge and expertise that keeps pace with the industry.
What do you like best about your practice area?
Laura: I like that the practice is constantly evolving. I learn something new with every project—there is always a new regulation or guidance document to catch up on! This also creates an opportunity for junior associates to become subject matter experts on new policy developments. In my case, I was able to work on telehealth projects at the very beginning of my career, pre-COVID, and developed a deep understanding of the digital health regulatory landscape that was very helpful when the adoption of remote services exploded during COVID. I also really enjoy working with our clients, most of whom are focused on better serving patients and improving health outcomes. To be able to help them with this work, in some small way, is very meaningful. And being at Jones Day, of course, means we get to work with clients who are the best at what they do. The projects we work on are often complex and cutting-edge and require a team-oriented approach; nowhere does a team come together better to face challenges than at Jones Day.
What are some typical tasks that a junior lawyer would perform in this practice area?
Laura: Junior lawyers are involved in all aspects of the projects we work on, working alongside and with the guidance of partner and senior associate mentors. Typical tasks include conducting legal and regulatory research, communicating with clients and regulators, drafting pleadings and motions, drafting regulatory submissions, drafting and revising transactional documents, reviewing documents (due diligence or discovery), and participating in witness interviews. My personal favorite task is conducting deep regulatory research and trying to distill that into practical guidance for our clients.
How do you see this practice area evolving in the future?
Heather: The clear trend in the health sector is toward collaboration of participants across the industry. And while the pandemic accelerated this trend, it was in fact emerging before the health crisis. There are a number of factors causing this, including: globalization of healthcare, innovation and new technologies, new entrants and new roles for health industry participants, consumer-driven healthcare, and pressures on pricing and demand for transparency. As the industry evolves, so too must our legal practice and the way we approach the clients we serve. This is where Jones Day excels thanks to an international footprint, cross-practice collaboration, and client-oriented culture. This allows us to deliver not only on a specific matter, but also to appreciate other factors that may impact the client.