McDermott Will & Schulte, a global law firm

Emily Jane Cook serves as counsel to clients in the healthcare sector from start-ups to established market leaders on a wide range of critical regulatory matters to ensure compliant business operations. Her guidance allows these organizations to prospectively and retrospectively manage the risks associated with operating in a high-complexity and highly-regulated sector.

A national authority on the 340B drug pricing program, Emily also helps clients across the country navigate a wide range of complex federal and state healthcare regulations. Her counsel encompasses issues such as navigating federal and state fraud and abuse laws, development of innovative models for healthcare delivery, Medicare provider-based and co-location rules, pharmacy laws and licensure, graduate medical education, and federally qualified health centers. This depth of knowledge across many regulatory issues allows her to provide her clients with comprehensive legal advice and guidance, which allows them to fully evaluate risks in their business and clinical operations. She works closely with colleagues in McDermott’s diverse practice areas to deliver fully realized solutions for her clients.

Emily’s deep insights into US healthcare regulation stem from her previous tenure at the US Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA). For more than five years, she worked with providers and across government agencies to address regulatory barriers to healthcare delivery. She advised senior HHS leadership on Medicare and Medicaid regulation and reimbursement issues affecting rural communities and providers, and served as senior policy advisor to the National Advisory Committee on Rural Health and Human Services.

Emily is an active member of the American Health Law Association, where she most recently served as the Chair of their Medicare and Medicaid Institute. She is also a member of the firm’s Health/White Collar cross-practice group.

Steven J. Schnelle is a trusted advisor to investors, executives, general counsel, and business operators in the healthcare and life sciences sectors, delivering actionable strategies to help them achieve market leadership, drive transformative growth, and navigate complex regulatory landscapes. With a national reputation for his transactional acumen and regulatory insights, Steven brings clarity and alignment to multifaceted arrangements, empowering organizations to excel in today’s dynamic healthcare environment.

Steven is a recognized authority in national reimbursement strategy, enabling clients to maximize the value of healthcare services and products. His counsel is particularly sought after by executive leadership teams and general counsel in hospital systems, as well as by professional groups; pharmacy service providers; clinical laboratories; and manufacturers of pharmaceuticals, medical devices, and durable medical equipment. He has extensive experience in advising on cutting-edge regulatory developments and innovative business models, ensuring his clients remain competitive and compliant.

Core Areas of Experience:

• Healthcare Mergers and Acquisitions (M&A). Guiding transactions involving changes of ownership and control with a focus on seamless regulatory coordination
• Federal Healthcare Oversight. Managing audits, investigations, and compliance with federal programs
• Third-Party Payer and Reimbursement. Addressing challenges and opportunities in payer participation and payment structures
• Medicare Administrative Appeals. Driving favorable outcomes in high-stakes appeals
• Sector-Specific Regulations. Navigating the nuanced regulatory requirements of health facilities, corporate practice, pharmacy, clinical laboratories, hospice care, and pharmaceutical/device manufacturing
• Pharmacy Matters. Counseling pharmacies on state and federal regulatory frameworks, Medicare enrollment disputes, and revocations

Steven has also cultivated a niche practice in navigating the complexities of the 340B Drug Pricing Program, providing tailored guidance on program development, audit response, manufacturer repayments, and litigation. His ability to resolve intricate issues relating to duplicate discounts and alleged diversion has earned him accolades from healthcare providers and pharmacy services providers alike.

Thought Leadership

Steven’s thought leadership has been widely recognized, with accolades from Chambers USA and other prestigious legal directories. He is a sought-after speaker at industry conferences, addressing topics ranging from healthcare M&A trends to reimbursement innovation. His insights have also been featured in leading publications, and he frequently mentors the next generation of legal talent in the healthcare sector.

Kelsey R. Reinhardt focuses her practice on regulatory and transactional matters affecting a wide range of clients across the healthcare industry.

While in law school, Kelsey competed as a semi-finalist in the USC Gould School of Law Hale Moot Court Honors Program and served as events chair for the Women’s Law Association.